chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (Did not want to drink her coffee, taste was terrible), SOMNOLENCE (Slept off and on all day), CHILLS (Severe chills/Shivering all night), MYALGIA (Aching) and FATIGUE (Fatigue/Felt zapped) in a 76-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. Concurrent medical conditions included Type 1 diabetes mellitus. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced CHILLS (Severe chills/Shivering all night), MYALGIA (Aching) and NAUSEA (Nausea). On 06-Feb-2021, the patient experienced TASTE DISORDER (Did not want to drink her coffee, taste was terrible), SOMNOLENCE (Slept off and on all day) and FATIGUE (Fatigue/Felt zapped). On 06-Feb-2021, CHILLS (Severe chills/Shivering all night), MYALGIA (Aching) and NAUSEA (Nausea) had resolved. On 07-Feb-2021, TASTE DISORDER (Did not want to drink her coffee, taste was terrible), SOMNOLENCE (Slept off and on all day) and FATIGUE (Fatigue/Felt zapped) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2020, SARS-CoV-2 test: positive positive positive for Covid via nasal swab the end of sep2020. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient says that on the following dates of 05/Feb/2021 until 06Feb/2021, she felt about the same as when she had Covid. Patient is on a "pump" for type 1 diabetes. Treatment information was not provided. A follow-up call was made to the patient on 30/Jun/2021 and she said she is feeling fine. Does not want to provide any email ID. Consent denied and hung up the call. This case was linked to MOD-2021-016356, MOD-2021-016705 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Reporter details and events outcome updated.
This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Pfizer product on 02/02/2021 and 02/23/2021. They tested positive for COVID-19 on 09/16/2021 at the nursing home/rehab facility at which they were a resident. They were admitted to hospital on 09/23/2021 with primary complaints of hypoxia and respiratory failure, after not tolerating non-invasive ventilation at the nursing home. They tested positive again for COVID-19 on 09/24/2021. They then had  a Pulseless electrical activity arrest for about 15 minutes. They were intubated, and they experienced cardiogenic shock. Bilateral pleural effusions were also discovered on CT scan.  The individual remained hospitalized until their death on 09/24/2021.
Patient fainted and fell on the floor within 15 minutes of vaccination.  Patient felt nauseous and was transported to the ER by EMS.
PT RECEIVED PPSV23 SUBQ AFTER HER OFFICE VISIT, 10 MIN LATER SHE CALLS AND STATES AFTER SHE LEFT THE OFFICE SHE NOTICED THE AREA WAS ITCHING, WHEN SHE GOT HOME SHE NOTICED A RASH IN BACK OF HER ARM AND WENT UP INTO HER ARMPIT. ADVISED PT TO TAKE BENADRYL AND APPLY A COOL COMPRESS, CALL US BACK IF AREA GETS WORSE OR IF AFTER HOURS SEEK TREATMENT AT ER OR URGENT CARE.
This was my second new shingles shot. I had the old one a year ago. I spiked a fever of 101 for 7 hours. I was so dizzy I could not stand. Bedridden. Nauseous. One second day still not good. Third day better. Arm very sore but i expected that. This totally prevented me from doing regular activities.
Patient was given a second Bivalent booster prior to indication for this and was given within 6 months of previous dose
numbness in arms and legs   tingling in fingers   too dizzy to walk without aid   very unsteady
This spontaneous report as received from medical assistant refers to a patient of unknown demographics. The patient's concurrent conditions, medical history and drug reactions/allergies were not reported. Concomitant therapy included sterile diluent (MERCK STERILE DILUENT). On 07-NOV-2016 the patient was vaccinated with unspecified doses of expired VARIVAX (lot # K018960, expiry date: 15-OCT-2016) and/or M-M-R II injection (lot # K020188, expiry date: 22-OCT-2016) (dose, frequency and route were not reported) for prophylaxis (expired product administered). It was not reported that, sterile diluent (MERCK STERILE DILUENT) used to reconstitute vaccines was expired. The reporter stated that, it was unknown whether the patient received MMR II or VARIVAX separately or MMR II concomitant with VARIVAX. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Albumin status for M-M-R II is recombinant human albumin (rHA).
Injection given in rt. deltoid on 04.04.2007. Pt returned to clinic on 04.06.2007 with c/o pain, redness and swollen. Pt stated pain started about 5hrs later. Pt advised to put Ice on the site and take ibuprofen, also pt had labs drawn.
My son was given a vaccine on 11/8/99( he was 19 months) (DTaP), he became sickly, and had loud pitched screams. He was wheezing and very uncomfortable for days to come. Not being an over protective parent, as this was my 2nd child,  I called the office to make a nurse call, who made me an appointment to come in (to an alternate doctor at a different office as our main ped, was on holiday) I saw this doctor, and he said my son had "croup" and treated him with albuterol. I had instructions on how to keep the room moist and misted etc. My son continued to be sick for days/weeks to come.. on and off with spouts of uncontrollable screaming, though some days, though lethargic, he seemed a "bit better". on 11/29/99 he began to have a seizure.. this was for about 25-40 sec. (witnesses varied in time, it was so traumatic to everyone , one even said 2minutes!).. when he came to, he was weak, the ambulance came, gave him oxygen (which he began to fight like a bull and regained his strength), they took us to the emergency room, where he was said to have had a febrile seizure.. weeks to come he was glassy eyed and distant, no longer sought or made eye contact.. babble sounds and littlewords he had, became non exsistant or turned into humming noises. at 22 months he was diagnosed w/ a PDD. He is now 7 and is classified as having autism, as opposed to being child who  sufferd brain damage/injury (as noted the possible side effects could have been) from this vaccine.  Medical record rec'd on 07/25/2005 has no new terms to be added. Follow-up: Language impaired / learning impaired. Tics stereotype, socially removed / socially inappropriate. Hyperactive, attention deficit. My son was permanently brain damaged by these vaccines - He had seizure activity and was never the same.
swollen neck glands on right side for 3 weeks; chills; fever 99.6 - 101.9 for 5 days; I was exhausted; Covid toe,(red rash pain and burn) on left big toe; Covid toe,(red rash pain and burn) on left big toe; Covid toe,(red rash pain and burn) on left big toe; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 24Aug2021 14:30 (Lot number: EWO165) at the age of 59 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing); "hashimotos" (unspecified if ongoing). Concomitant medication(s) included: BYSTOLIC; ARMOUR THYROID. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer, lot number=EWO217, lot unknown=False, administration date=03Aug2021, administration time=01:30 PM, dose number=1, vaccine location=Left arm, After I got first shot on left side which caused swollen neck glands on left side which lasted for 3 weeks), administration date: 03Aug2021, when the patient was 59 years old, for Covid-19 immunization, reaction(s): "swollen neck glands on left side which lasted for 3 weeks". The following information was reported: LYMPHADENOPATHY (non-serious), outcome "recovering", described as "swollen neck glands on right side for 3 weeks"; CHILLS (non-serious), outcome "recovering", described as "chills"; PYREXIA (non-serious), outcome "recovering", described as "fever 99.6 - 101.9 for 5 days"; FATIGUE (non-serious), outcome "recovering", described as "exhausted"; ERYTHEMA (non-serious), RASH (non-serious), PAIN IN EXTREMITY (non-serious), BURNING SENSATION (non-serious), outcome "recovering" and all described as "Covid toe,(red rash pain and burn) on left big toe". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymphadenopathy, chills, pyrexia, fatigue, erythema, rash, pain in extremity, burning sensation.  Additional Information: facility type vaccine: Public Health Clinic/Veterans Administration facility. if other vaccine in four weeks was no. other medications in two weeks was Bystolic, Armour Thyroid. I also got Covid toe,(red rash pain and burn) on left big toe, and have had it for 7 days so far. It was reported adverse event start date and time was 06Aug2021 02:30 PM. if covid prior vaccination was no. if covid tested post vaccination was yes. No known allergies.   No follow-up attempts are possible. No further information is expected.
Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). The delivery occurred on an unknown date.  At the time of the report, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.            Concomitant medications were not provided. Treatment information was not reported.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female (age unknown). Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
It was reported that a 23 year old male patient received a Yellow Fever vaccination on 09/09/02 at 9:00 pm. Reportedly on 09/10/02, the patient developed an area of cm or localized redness,swelling,and itching at the immunization site. Treatment of Benadryl and Motrin was prescribed. The patient reportedly recovered from this experience.
1st dose year ago, 2nd not yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date, over a year before date of reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 07-DEC-2022 Reporter's Comments: The pharmacist enquired if person failed to receive the 2nd dose for over a year, did the series need to be restarted.  The reporter consented to follow up. No further information provided The reporter mentioned submitting to safety as potential adverse event out of caution. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
a sore developed under the end of the band aid strip used to cover the injection site. The injection hole disappeared but the sore and some redness around it still present. The sore is about 1/8" around.  Both upper arms are sore.
after shot i didn't have any problems and then i came home. On Monday I slipped getting out of bed and hit my head on the floor , i couldn't move or talk,  Wife called 911 and went to ER. had a Stint put in my head. Went into ICU discharged. I was diagnosed with Stroke
Right side of jaw and ear area pain, mild swelling/inflammation. Rear molars would not meet together from inflammation. Hard to chew on the left side. At times feeling like an ear infection which I have not had in over 50 years.  It began 3/17/2021 and almost completely diminished on 3/22/2021
Full Dose Not Administered; Leakage from Syringe; Initial Report Received on 29-Sep-2020  A Medical Clinic Practice Manager reported to an Account Manager that a 23-year-old female received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and there was leakage between the chamber and top of the syringe while it was being administered.  No medical history was reported.   No concomitant medications were reported.  On 28-Sep-2020, the patient received a dose of HEPLISAV-B (Lot #933625, expiration date 12-Sep-2021 and NDC # not reported) to the right deltoid, and there was leakage between the chamber and top of the syringe while it was being administered. The patient did not report any reactions to the injection.   At the time of the report, no additional information was available.   At the time of report, the quality investigation was in progress and there was no indication of a malfunction.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
short generalized sz w/fever the noc following vax was seen by another MD in ER
Headache; chills; joint ache; fatigue; injection site pain; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 30Mar2021 at 19:15 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient did not have any allergies to food, medications, or other products. The patient did not receive any concomitant medications. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021, the patient experienced headache, chills, joint ache, fatigue and had injection site pain. Therapeutic measures were taken as a result of the events headache, chills, joint ache, fatigue and injection site pain which included treatment with ibuprofen (MANUFACTURER UNKNOWN). The clinical outcomes of the events headache, chills, joint ache, fatigue and injection site pain were resolved on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
My arm was burning as the vaccine was administered. About 15 minutes after, my legs felt itchy.  About 5- 10 minutes later, I was itching all over really bad. The nurses in the observation room contacted the doctor. I was instructed to take Zyrtec 10mg twice daily for 3 days. Today is my second day. The itchy feeling is there, just not as strong as yesterday.
Dizzy; Magnet is attracted to injection site; sore arm; This spontaneous case was reported by an other caregiver and describes the occurrence of DIZZINESS (Dizzy), VACCINATION COMPLICATION (Magnet is attracted to injection site) and VACCINATION SITE PAIN (sore arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced DIZZINESS (Dizzy), VACCINATION COMPLICATION (Magnet is attracted to injection site) and VACCINATION SITE PAIN (sore arm). At the time of the report, DIZZINESS (Dizzy), VACCINATION COMPLICATION (Magnet is attracted to injection site) and VACCINATION SITE PAIN (sore arm) outcome was unknown.            Concomitant products were not provided.  Treatment medication were not reported.
No side effects; PROQUAD and VARIVAX were inadvertently administered at the same time to a patient; This spontaneous report was received from a nurse practitioner and refers to a 15-month-old female patient. No information regarding patient's pertinent medical history, drug reactions, allergies and concomitant medications was reported.  On 20-JUN-2023, the patient was inadvertently vaccinated at the same time with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status: recombinant Human albumin (rHA)) (PROQUAD) subcutaneous injection, at a dose of 0.5 ml, lot # W036939, expiration date 19-MAY-2024, subcutaneously and varicella virus vaccine live (oka/merck)(VARIVAX) subcutaneous injection, at a dose of 0.5 ml, subcutaneously, lot # W018837, expiration date reported as 14-MAR-2024, but upon internal validation it was established as 14-JUN-2024 both as routine immunization (accidental overdose). No side effects reported.
Hive approx 2 hours after vaccine. Resolved within 15 min skin discoloration a few hours after vaccine and day after Fatigue- day of and day after vaccine tingling in mouth- day after vaccine   took Claritin and symptoms resolved
Bruise; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CONTUSION (non-serious), outcome "unknown", described as "Bruise".  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Tightening of throat, could not breathe. Anaphylactic response. Pt has many allergies.
pain, numbness and tingling inner aspect of left arm to radiating to thumb, started after getting vaccine but progressively became worse
Annoyances appeared; ringing in the ear 24 hours; Headaches; Hand arthritis; fatigue; they appeared is a continuous malaise that is changing my way of life and everything; I don't feel good emotionally; I am depressed; This is a spontaneous report from a non-contactable consumer (Patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration on Jan2021 as dose 1, single, dose 2 via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced annoyances appeared, ringing in the ear 24 hours, headaches, hand arthritis, fatigue, patient never had they appeared is a continuous malaise that is changing my way of life and everything, patient don't feel good emotionally, patient depressed. The outcome of event was unknown.  Information on the lot/batch number has been requested.
I started having stomach pain that was unrelenting. I went the emergency room and then I was starting to have pain in my neck on the left side.  They did some tests but no treatment. The next day I was down for the whole day. The stomach pain lasted a little more than 24 hours. The pain came and went. I have not had the symptom reoccur but my stomach is still a little tender.
Extreme tiredness - slept for hours, difficult to stay awake.   I had a migraine on April 18th, but did not take any medication for it. Woke up on Monday feeling good, but was exhausted that day (19th), and Tuesday  (20th).  Woke up with bad migraines on Tuesday and Wednesday mornings (April 20th and 21st).
Pt recvd vax MAR92 & following the vax pt exp aches & pains that were described as an arthritis type reaction & a fever;
Patient was Covid + on 10/31/2021. Patient received Pfizer vaccine with 1st dose on 03/19/2021 and 2nd dose on 04/09/2021.  Per H & P:   Assessment/Plan    #GI bleed likely upper GI bleed related to supratherapeutic INR  -Continue PPI  -GI medicine following , endoscopy when patient more stable  -Started on diet   #Acute blood loss anemia secondary to above  S/p transfusion  Monitor for now  #Acute on chronic respiratory failure related to possibly COPD versus Covid  Wean off oxygen as tolerated  Also on empiric antibiotics for possible pneumonia patient clinically appearing well  De-escalate if patient remains stable   #Supratherapeutic INR  S/p reversal with vitamin K   #Prior history of DVT on Coumadin which is currently on hold  -Resume anticoagulation when hemoglobin stable and okay with GI medicine   #COVID-19 positive status  -vaccinated  Patient appears to be doing fairly well up with this  -Continue steroids  -Monitor respiratory status   #Hypertension blood pressure on the lower side  Likely related to above currently improving   #History of chronic venous insufficiency and recent cellulitis   DVT prophylaxis  Active Diagnoses      GI bleed    Chief Complaint   Shortness of breath   History of Present Illness     Patient is a pleasant 63-year-old Caucasian male with past medical history significant for COPD on 3 L, chronic venous insufficiency with lower extremity swelling, history of DVT on Coumadin, diabetes type 2 came into the hospital for dark stools.  Patient was recently admitted to the hospital about 2 weeks ago for COPD exacerbation and did fairly well and went home.  Has been on Coumadin for long time for history of DVTs.  Patient just went back on his old regimen post discharge for Coumadin and started noticing for the last 2 to 3days stools which made him concerned and come to the hospital.  Patient had a critical hemoglobin of 4.4 upon admission.  INR was also critical with more than 24.3.  Patient reversed and was transfused also and last hemoglobin was 7.5.  His last  bowel movement was this morning with persistent dark stools.  He was seen by GI and no plans for endoscopy at this time.  Patient also tested positive for Covid patient had to be placed on BiPAP upon admission and is being weaned off at this time currently being weaned off of at this time .  Breathing well today.  Denies any significant difficulty breathing today.  No nausea vomiting.  No headache no blurry vision no fevers at home.  Patient has been vaccinated with 2 doses.