chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a other health professional via call center representative and described the occurrence of injection site bruising in a 65-year-old female patient who received SHINGRIX (batch number HM3NC, expiry date 13th April 2021) for prophylaxis. On 22nd January 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In January 2019, less than a week after receiving SHINGRIX, the patient experienced injection site bruising, injection site erythema, injection site warmth, injection site swelling, injection site mass and injection site induration. On an unknown date, the outcome of the injection site bruising, injection site erythema, injection site warmth, injection site swelling, injection site mass and injection site induration were not recovered/not resolved. It was unknown if the reporter considered the injection site bruising, injection site erythema, injection site warmth, injection site swelling, injection site mass and injection site induration to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on left arm. After receiving the SHINGRIX, the patient developed bruising, redness, warmth, swelling and a hard mass at the injection site.
In less than 12 hours of receiving the flu shot my arm  was swollen, red , and warm to touch. It was extremely painful to move the arm and shoulder where the shot was given. By the next day i started having chills and trouble breathing. Once my rescue inhaler did not help the breathing i decided to go to the hospital. There i recevied breathing treatments by the respiratory technician and was given IV medicine for my shoulder. I was diagnosis with a allergic reaction to the flu shot and cellulitis in my right shoulder were the shot was given.
Woke up on 3/2 with "incredible nausea" and stomach cramps. Took Zofran with no improvement. 3/3 symptoms still present but milder, so he started taking Truvada for HIV prophylaxis, then nausea and stomach cramps worsened. Stopped Truvada on 3/5. Today on 3/9, nausea persists but mild; stomach cramps fully resolved.
vaccine was expired, no temperature excursions occurred and Moderna determined the vial "maintained the activity necessary to protect against the SARS Co-V 2 virus at the time of administration".   Patient reported no adverse reactions.
Three days after receiving the vaccine, I developed a blood clot in the lining of my stomach.; This is a spontaneous report from a contactable consumer. A 42-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: EN6201), dose 1 via an unspecified route of administration, administered in Arm Left on 15Mar2021 11:30 as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) included ethinylestradiol, norgestimate (SPRINTEC) taken for an unspecified indication, on an unspecified date. On 18Mar2021 05:30 the patient experienced three days after receiving the vaccine, developed a blood clot in the lining of her stomach (thrombosis). The patient was hospitalized for three days after receiving the vaccine, developed a blood clot in the lining of her stomach for 3 days. Therapeutic measures with blood thinners were taken as a result of three days after receiving the vaccine, developed a blood clot in the lining of her stomach. The outcome of the event was recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Headache 1st day Day 2/3 severe body aches, muscle and joint pain, fatigue, brain fog, insomnia
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 73 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 18Jan2021 as dose 1, single (Lot number: EL8982), in left arm, on 07Feb2021 as dose 2, single (Lot number: EL8982), in left arm, on 30Sep2021 as dose 3 (booster), single (Lot number: 30145BA), in left arm and on 23May2022 as dose 4 (booster), single (Lot number: FM9992), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Elevated BP" (unspecified if ongoing); "elevated cholesterol" (unspecified if ongoing); "menaires" (unspecified if ongoing). Concomitant medication(s) included: VERAPAMIL; AMLODIPINE; ATORVASTATIN; ESTRADIOL; VITAMIN D NOS. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Blood cholesterol: (unspecified date) Elevated; Blood pressure measurement: (unspecified date) Elevated; SARS-CoV-2 test: (unspecified date) Positive; (Dec2022) Negative; (Dec2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19: Paxlovid.
Tuesday 3/30 in the evening 3 middle toes on right foot began to swell. Over course of night, toes swelled, turned red, became painful. I iced them overnight and took ibuprofen. By Thursday morning they had developed blisters (the kind you get from hot spots / shoes rubbing). The pain subsided within ~36-48 hours, but the swelling, redness, and blisters remained for several days, slowly resolving over the course of about 7-10 days, with the blisters resolving first and the swelling and redness taking a few days longer. The blisters never did turn purple or peel like chillblains, they just resolved the way normal blisters do.
Mo. reports that when pt. awoke the next day his left arm was numb. He came into the health facility on 6/24/10 with his mother. He says he still has numbness and tingling down his left arm to his thumb all the time. The pt. demonstrated that he cannot extend his left arm out to side, front of him, or overhead without shaking. His arm eventually fell to his side each time. Pt. did have equally strong grasp in each hand and is able to perform adl's without difficulty.
pt recv vax 22JUL97 & pt exp inc bilirubin levels;levels were reported to be 3X nl values;Bilirubin levels will be redrawn as reported by the office manage;
H1N1 Clinic held for community. A one year old patient with foreign only speaking parent interviewed and child received 0.25 injection of the H1N1 on XX-XX-2009. On entering injection on the XXX XX-XX-2009 secretary found parent had taken child to the Pediatrician on XX-XX-2009 and H1N1 was recorded on the XXXX. RN in the clinic called the H1N1 Specialist on state level and instructions provided as to what needed to be done. (1st) record 2nd injection even though invalid (once entered) 2nd notify parent of specific return date for child's 2nd Injection and thru interpreter state date (28 days from invalid injection not the first injection that was given on XX-XX-2009) and ask parent to whom she will be taking child to get parent to be specific and state date and have parent call so child can be placed on schedule either clinic or Pediatrician and have her repeat Instructions to interpreter for proven verification and complete understanding (3rd) Pediatrician notified and information provided so their group will have that information as well All three instructions carried out as directed.
Headache, Fever, NauseaVomiting, fatigue and chills Narrative:  Employee reported fever, headache, fatigue, nausea and chills. Resulted in unable to work 3/15/2021.
Several days after the injection  a red circular area about 2 inches in diameter appeared near the injection site on the same arm. It wasn't warm to touch and did not spread. Initially it itched a bit but stopped in about 1-2 days. It wasn't hard nor painful. It is beginning to fade.
Fever, body aches, fatigue - all lasting 12 hours, then resolved. Also having cellulitis to injection site, started with adverse symptoms, still having & redness is getting larger now (55 hours after injection)
Initial vaccine side effects I had chills and achiness for 24 hours. Normal vaccine side effects. In June I tested positive for COVID. I felt post nasal drip thinking it was allergies in the beginning. 2 days later my muscles and joints were achy. I had a slight fever, and a scratchy throat and cough. I tested for COVID at home and tested negative first and then positive. I called my doctor and told her my stats and my O2 levels. This persisted for the next 4 days and I slept and took Tylenol. I was tired and fatigued and by the end of the week I was feeling a bit more energetic but still as the day progressed that also diminished. Today, July 13, I still have a slight cough. My o2 stats are back to normal and my energy is back to normal.
Boke out in rash 1 inch below the injection site; Itched; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE RASH (Boke out in rash 1 inch below the injection site) and PRURITUS (Itched) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Allergy to Latex).    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE RASH (Boke out in rash 1 inch below the injection site) and PRURITUS (Itched). At the time of the report, VACCINATION SITE RASH (Boke out in rash 1 inch below the injection site) and PRURITUS (Itched) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medicines reported. Treatment information included Benadryl.
Patient came in for a flu shot. When I announced the name of the patient for the next vaccine to enter the room, she stepped in thinking that it was for her. She received the covid vaccine when she did not ask for it.
recurring ache/ soreness; extreme pain; burning sensation; told that May be the vaccine was still frozen; sore arm for several days/sore arm for several days after, but the same as I experienced after the first shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (extreme pain), BURNING SENSATION (burning sensation), PRODUCT STORAGE ERROR (told that May be the vaccine was still frozen), MYALGIA (sore arm for several days/sore arm for several days after, but the same as I experienced after the first shot) and VACCINATION SITE PAIN (recurring ache/ soreness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced PAIN (extreme pain), BURNING SENSATION (burning sensation), PRODUCT STORAGE ERROR (told that May be the vaccine was still frozen) and MYALGIA (sore arm for several days/sore arm for several days after, but the same as I experienced after the first shot). On an unknown date, the patient experienced VACCINATION SITE PAIN (recurring ache/ soreness). On 22-Mar-2021, PAIN (extreme pain), BURNING SENSATION (burning sensation) and PRODUCT STORAGE ERROR (told that May be the vaccine was still frozen) had resolved. At the time of the report, MYALGIA (sore arm for several days/sore arm for several days after, but the same as I experienced after the first shot) and VACCINATION SITE PAIN (recurring ache/ soreness) outcome was unknown.            Patient stated that he experienced sore arm when he had his first shot for flu Concomitant and Treatment was not specified.    This case was linked to MOD-2021-331581 (Patient Link).
Ear infection and yeast infection dx'd on 3/31/02. Unexplained bruising and discoloration evident on 4/18/02. Dx'd and treated as ITP (Immune Thrombocytopenic Purpura) with platelet count of 6,000 on 4/19/02. Treated with human immunoglobin on 4/19/02 and 5/8/02 (IV). This is not considered acute until pt has had platelet count in normal range for 6 months (normal range is 150,000-400,000. Platelet destruction began right after immunizations on 3/29/02. It took 3 weeks to the day, to notice enough bruising to get him checked by a physician and have lab work done. He was hospitalized. He was also treated in another city. MD was consulted for treatment on 4/19/02 as well. The pt his still under care and treatment.
on 4/12: severe headache (8AM-2PM), sweats (11AM-12PM),  then chills(12PM-8PM),  then congested (9PM till sleep)
This case was reported by a pharmacist via other manufacturer and described the occurrence of therapy non-responder in a female patient who received ENGERIX B. Co-suspect products included ENGERIX B. On an unknown date, the patient received ENGERIX B at an unknown dose and ENGERIX B at an unknown dose. On an unknown date, an unknown time after receiving ENGERIX B and not applicable after receiving ENGERIX B, the patient experienced therapy non-responder and circumstance or information capable of leading to medication error. On an unknown date, the outcome of the therapy non-responder and circumstance or information capable of leading to medication error were unknown. It was unknown if the reporter considered the therapy non-responder to be related to ENGERIX B. Additional details were provided as follows: The patient received ENGERIX B at unknown date and unknown dose. The pharmacist stated that the physician wanted to double the patient's dose since ENGERIX B did not work. This led to therapy non-responder. If the patient receives double dose of ENGERIX B then it would be overdose and off label use by physician. This led to circumstance or information capable of leading to medication error.
Feeling worst/ Condition worst after having COVID vaccine; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling worst/ Condition worst after having COVID vaccine) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In July 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced FEELING ABNORMAL (Feeling worst/ Condition worst after having COVID vaccine). At the time of the report, FEELING ABNORMAL (Feeling worst/ Condition worst after having COVID vaccine) was resolving.            No concomitant medication provided. No treatment information mentioned.  In 2021, patient was feeling worse and felt worse after having COVID vaccine.  Reporters causality of events with Humira was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
20 minutes after the vaccine was given to me I developed a rash on my arms,  chest,  neck and face.  The pharmacist gave me 25mg of Benadryl and waited to see if that would stop the reaction.  Ten minutes later the rash was all ver my legs,  I started having heart palpitations,  my lips started to swell,  my tongue started tingling and my chest was getting tight.  The pharmacist gave me an epicenter injection in my left thigh and called paramedics.  Paramedics came and administered 130mg of solumedrol after listening to my breathing and my chest sound still tight along with 50 mg of Benadryl thru my IV.   They took me to a Hospital,  my rash was gone and my breathing was back to normal.  I stayed in the ER for observation for 2 hours with no further reactions so I was discharged with a prescription of prednisone for five days.
secondary was itchy skin; This is a spontaneous report from a contactable Consumer or other non-HCP (patient). A 66-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6Z08), dose 2 via an unspecified route of administration, administered in Arm Right on 10Mar2021 at 11:30 AM (at the age of 66-year-old), as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Environmental allergies, hypothyroidism and sleep apnea. The patient had no covid prior vaccination. The patient had no known allergies. Concomitant medication(s) included Sertraline; Azelastine hydrochloride (ASTELIN [AZELASTINE HYDROCHLORIDE]); Diphenhydramine hydrochloride (BENADRYL) and Fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]), all taken for an unspecified indication, start and stop date were not reported. The patient previously received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9262), via an unspecified route of administration, administered in Right arm on 17Feb2021at 09:30 AM (at the age of 66-year-old), as single for covid-19 immunisation and four days after, he experienced burning sensation on skin and Severe rash on neck. The patient received no other vaccine in four weeks. The patient had not been Covid tested post vaccination. On an unspecified date in Mar2021, after the second dose of vaccination, the patient experienced itchy skin. The patient outcome of the event was Unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Patient complained of feeling as if something was stuck in her throat and she could not swallow, that her throat felt "fat". As the minutes passed, the feeling of fullness was more pronounced. We offered EPI-PEN and to call 911. Patient wanted 911 only. We called 911, took her blood pressure (188/119). Paramedics arrived within 1 minute. After examination, patient was transported to hospital at 1:30p.m. accompanied by family members. At 3:55p.m.,  I spoke to her fiancé to inquire about her well being. She was still at ER at 3:55 p.m. She was given Benadryl, EpiPen, and Prednisone. Fiancé said she was breathing better but there was a rash and itching at injection site which was being treated with Benadryl and Prednisone. Fiancé said patient was frustrated at having to be at emergency room.
After injection, asked if patient needed to sit, patient reported felt okay to leave clinic. Had episode of syncope as exiting clinic exam room. Facial pallor. Able to arouse in one minute. Given juice and a granola bar. Parent reports child had not eaten yet that day. Patient remained in clinic for 15-20 more minutes until feeling stable enough. Patient denies any history of syncope after injections.
Five minutes after injection patient became nauseous and vomited. Pulse 100. BP 118/76. Patient waited 20 minutes after vomiting. Felt fine. Left office.
Patient started having myalgia, chills, nausea on the next day of the vaccination. on 2nd day (12/29) patient had chest pressure which made her present to Hospital ED. She had troponin elevation to 1.14. Cardiac Catheterization was done which was negative. On Trans Thoracic Echocardiogram, patient was found to have hypokinesis of the mid and distal segment with some sparing of apex proving Takotsubo (stress induced) cardiomyopathy. Patient did not have any underlying  emotional or physical stress going on in her life or family. Till now extensive infectious as well as inflammatory work up is done to rule out any secondary causes of cardiomyopathy which till date have remained negative.  As a diagnosis of exclusion, her presentation seems to be COVID-19 vaccine induced Takotsubo Cardiomyopathy
Large area of edema and erythema 6 cm x 7cm in right deltoid (14 days post immunization). Very warm to touch. Actual induration 1.5 cm round area - one for DTaP, one for Hep A. Suspect local Rxn to DTaP. We're reporting it due to the large size of erythema and edema - covers most of this child's right deltoid (initial swelling was 3.5" x 2.5").
Began with post-nasal drip, then headache, sneezing.  Over next 30 hours, progressed to severe headache with aches across chest and arms, nausea, 'adrenaline rush' sensation with tightening of chest and asthma symptoms-short of breath, cough, continued tight-chested feeling. So far, this has lasted through today, 10/13 at 1700.  I will be seeing my own PCP tomorrow as symptoms have persisted.
pediatric patients (children) were given the adult dose of Havrix.; pediatric patients (children) were given the adult dose of Havrix.; This case was reported by a physician via call center representative and described the occurrence of overdose in a child patient who received HAV (Havrix 1440) for prophylaxis.   On an unknown date, the patient received Havrix 1440. On an unknown date, unknown after receiving Havrix 1440, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.  Additional details were provided as follows: The reporter was a pediatrician. The age at vaccination was not reported. The pediatric patient was given the adult dose of Havrix, which led to overdose and adult product administered to child. The pediatrician´s office was still trying to identify the patient. Patient identifiers was not available till the time of reporting. The reporter consented to follow up. This is 1 of the 9 link cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021120523:same reporter US-GLAXOSMITHKLINE-US2021120525:same reporter US-GLAXOSMITHKLINE-US2021120526:same reporter US-GLAXOSMITHKLINE-US2021120528:same reporter US-GLAXOSMITHKLINE-US2021120519:same reporter US-GLAXOSMITHKLINE-US2021120521:same reporter US-GLAXOSMITHKLINE-US2021120516:same reporter US-GLAXOSMITHKLINE-US2021120532:same reporter
Approximately four hours after receiving the vaccination patient developed fatigue, "fogginess". Symptoms continued until this afternoon when patient developed palpitations, dyspnea with exertion, and myalgias with right anterior chest pain. Presented to this emergency department at that time.
patient recevied 0.5ml instead of 0.25ml dose.  No adverse affects.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient), for a Pfizer sponsored program (159558). A female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient developed viral gastroenteritis/stomach virus. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
A non-serious spontaneous report of a patient received expired FLUMIST was received from a registered nurse concerning a 14-year-old female. The patient's medical history and concomitant medications were not included. The patient received a dose of expired FLUMIST. The product expired on 20-Feb-2011. On 26-Feb-2011, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information received on 05-May-2011 and incorporated into case: no late occurring adverse events.
UrticariaPruritus, HYPERtension, numbness/itchines/tingling in mouth and throat, treated emergently with Prenisone. Narrative: