chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DIED; This spontaneous report received from a consumer via social media via a company representative concerned a patient of unspecified age, sex, race and ethnic origin. 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, and batch number were not reported) 1 in total, dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, it was reported that. "Facts I know a nurse an plenty of ppl fully vaxed that's died regardless....so... On an unspecified date, the patient died from unknown cause of death. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This report was associated with product quality complaint: 90000245172.; Sender's Comments: V0-20220809549-covid-19 vaccine ad26.cov2.s-Died. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Mother noticed red raised rash on 4/22/11 - went to walk in & was given script for prednisolone - by 4/23/11 - rash was worse, seen in doctors office 4/23/11 dx allergic urticaria, PEDIAPRED 1 1/2 tsp BID x 3d. BENADRYL 1 tsp Q6 hours PRN seen on 4/25/11 with improvement of allergic urticaria.
I administered 2nd dose of Covid vaccine to a  patient.  23 yo male  Vaccine was given at 08:56 AM Right Deltoid.  At 8:58 pt c/o mild itching at the vaccine site.  I accessed pt's arm, no redness, no inflammation, cool to touch.  At 9:00 I administered 50 mg of oral benadryl.  Monitored patient for an extra 30 mins.  Pt respirations was at 20.  At 9:30 before pt had left, pt felt fine, no itchiness, no redness, no inflammation, cool to touch.  I advised pt if he does not feel well or if sx returns and feel shortness of breath, difficult breathing to go to the ER.  Pt left with girlfriend and I advised the pt not to drive.  Pt left stable and ambulatory.  I notified my CM.
pain, redness, bruising, swelling 80x70 @ inj site, pt stated felt like a bee sting;arm sore 3-4 days;
p/vax pt started having trouble breathing-sounded like cramp only deeper;had T102.3 lasting on & off for approx 24hr;went to MD given decadron;mom reported pt had raised rash on trunk front & back;
After a month, I began to feel weak and trembly in my legs and arms. My legs felt like Jello. Very wobbly. Completely different feeling from my usual POTS symptoms. These come and go, meaning some days I have it all day, other days I don't have it at all. Over exertion can trigger it. My mouth also would twitch without provocation but that seems to have tapered off.
Initial symptoms were fatigue, malaise, headache. Fever started sometime during the night, which was accompanied by chills and rigors. Fever at 0600 on 1/8/2021 was 105.7.
5/9-traveled to; 5/22- getting sick (likely pertussis); 5/27- self-test positive for C-19; 5/29-Official PCR test positive; 6/5 - Official PCR test negative; 6/6-flew back home; 6/8 - severe sinus infection; still coughing; antibiotics; 7/13- tested for pertussis, covid and pneumonia due to long term cough; low grade fever which had continued from 5/22 til present, positive for pertussis.
I received the vaccine around 2 o?clock on Saturday. When I woke up on Sunday around 7:30 AM I had chills and fever, myalgia and joint soreness. We broke the fever down with ibuprofen, and I was still sore but relatively better feeling most of the day until around 6:45 pm when I came down with a really bad wave of chills and rising fever.
J96.00 ACUTE RESPIRATORY FAILURE 5/1/2022 RIGHT FEMORAL NECK UNSPECIFIED TYPE FX, INIT
He developed a tic shortly after having received the 1st COVID vaccine.   Mother can not give an exact date, only that it started about 1 month prior to our visit on 9/3/21.   The tic consists of his sharply turning his head to the left.  It is random, but never happens when his head is laying or propped on something.  It occurs only when his head is not against any obstacle.  He says that he notices when he is doing  the movement.  He was seen in another clinic 2 days prior to our visit and they planned on referring him to neurology. PT thought the movement started after he shot a gun.  It didn't hit him, but it backfired hard and he was not wearing any ear plugs at the time.
Patient has received MENVEO previously. Nurse practitioner read Men B. Discussed with another physician order given for BEXSERO. Nurse got order and gave. Patient has Sickle Cell high risk patient. Nurse Practitioner believed indication was appropriate.
Body ache; Fever; Chills; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (Body ache), PYREXIA (Fever) and CHILLS (Chills) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. EL1283) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 08-Jan-2021 at 9:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021 at 11:00 PM, the patient experienced PAIN (Body ache), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PAIN (Body ache), PYREXIA (Fever) and CHILLS (Chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided.; Reporter'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.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 01/26/21 pfizer,Lot#EL9262 2nd 02/16/21 dose Pfizer,lot#EL9266 Diagnosed covid positive:08/04/21 Symptom onset:07/30/21 Exposure:unknown Symptoms:Fatigue, diarrhea,runny nose
This spontaneous report as received from a nurse refers to a 19 year old female patient with immune deficiency disorder, arthritis, ADHD, scoliosis and ovarian cyst. The reporter stated that the patient was vaccinated with RECOMBIVAX HB (intramuscular, dose was unknown) on 01-DEC-1994, 18-JAN-1995 and 22-MAY-1995. Concomitant therapies included ADDERALL (dose and frequency unknown). The reporter stated that the patient had titers drawn prior to starting school on an unspecified date. The reporter stated that the patients titers were low. The patient did not seek any medical attention. The outcome of the event was unknown. No additional information was reported. Additional information has been requested.
Had GARDASIL on 5/10/17, started having cold chills and convulsions that evening.  Went to  ER, dx with seizures.
Right lung is diminished leaving a lasting affect of difficulty breathing. Affects everyday tasks such as walking and cleaning and working.
Mom called the office on 8/4 to say that patient had a rash all over her body 10 days after receiving her vaccines. As of 8/8 the rash was much better and had mostly cleared up.
HOSP-HOSPITAL 9/18/2022  10/18/2022 HOSP-HOSP 7/23/2022  8/8/2022
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 30-JAN-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 10 microgram/1 ml (lot#J010613, expiration date 07-MAY-2016). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion three times. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 72, unknown and R; 48, 1 and R' -1 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Pt. said she had fainted after a vaccine before and always gets very nervous about the vaccine. I was trying to distract her by asking her questions about school and we completed the vaccine. She said she felt fine and then about 10 seconds later she fainted and slumped forward. I leaned her back and she was alert about 5 seconds later. She seemed a bit disorientated for about 10 seconds but then was perfectly oriented to person, place, and time. She laid down for a few minutes and had some sips of water and then felt fine. I asked her to stay for 30 minutes to be observed since she did not have someone with her. She felt fine ever since and left with no issues. I asked her to contact me if she needed anything.
This case was reported by a healthcare professional and described the occurrence of antigenemia in a 28-year-old male subject who was vaccinated with Hepatitis B vaccine recombinant (Hepatitis B vaccine, manufacturer unspecified). Concurrent medical conditions included hemodialysis (started on 04 May 2009) and newly diagnosed renal failure. Concurrent vaccination included diphtheria and tetanus toxoids and acellular pertussis vaccine (manufacturer unspecified) given on 1 May 2009 and pneumococcal vaccines (manufacturer unspecified) given on 1 May 2009. Concurrent medications included PROCRIT. On 1 May 2009 the subject received 1st dose of Hepatitis B vaccine (20 mcg, unknown site). On 4 May 2009, 3 days after vaccination with Hepatitis B vaccine, the subject experienced antigenemia. He had entered the outpatient hemodialysis program and hepatitis B surface antigen was drawn, which came back positive. At that time, it was unknown that the subject had received a hepatitis B vaccination 3 days previously. The hepatitis B surface antigen was draw again on 13 May 2009 and was negative, and DNA virus tests were non-reactive. It was reported that liver function tests were normal. On 13 May 2009, the events was resolved. The healthcare professional considered the event was probably related to vaccination with Hepatitis B vaccine. Follow-up information received on 01 June 2009 indicated that antigenemia resolved on 21 May 2009, 17 days from onset. It was additionally indicated that the event was possibly related to treatment with hepatitis B vaccine.
10/17/2020 PATIENT STATES THAT IN THE EVENING SHE STARTED TO HAVE SEVER PAIN IN THE BACK AND KNEE.
Following administration of Td, pt exp body pain, h/a, backache, & mild temp elevation; several days p/inject, pt recovered;
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 01-AUG-2017 the patient received an expired dose of ZOSTAVAX (lot # M041510, expired on 27-JUL-2017) (dose and route were unspecified). The diluent used to reconstituted ZOSTAVAX was not expired. No adverse effects were reported. The outcome was not reported.
On Saturday May 7th I started feeling cold symptoms. I felt fatigue and congestion. I had extreme sore throat and burning nose. It went to my lungs and developed a dry cough the next day. I had an urgent care virtual visit because my cough was so bad. 102 fever for the first two days. My doctor prescribed Paxlovid. My hypertension levels were increased more than ever and I went to the ER to rule out a stroke.
2 inch red lump at injection site noted 9 days after inject. Unsure of when reaction  started
received an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 13-year-old female patient who received HBV (Engerix B pediatric) (batch number HN5BE, expiry date 16th September 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th October 2021, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 4th October 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient received an expired dose of ENGERIX-B which led to expired vaccine used.  No further events were reported. The consented to follow up.
This is a spontaneous report from contactable physician via a Pfizer Sales Representative. A 16-17 year old female patient of an unspecified race/ethnicity received TRUMENBA at single dose via an unspecified route on unknown date. Medical history and concomitant medication were unknown. On the same date the patient also received diphtheria vaccine, pertussis vaccine, tetanus vaccine (TDAP IMMUN) and a meningococcal vaccine. On an unknown date the patient experienced a temperature of 103 approximately for 24 hours. The event recovered on an unknown date.
Injection site soreness; Maternal exposure during pregnancy - 21 weeks, 2 days gestation at time of injection; This prospective spontaneous pregnancy case received on 23-Sep-2020 from other non-health professional (consumer) with additional information received on the same day (being processed together) and concerned a 34-year-old female patient.  The patient's medical history was not reported. The patient's concomitant medications included Prenatal vitamin (unspecified minerals and vitamins) and Vitamin D 5000 IU (colecalciferol), both used for unreported indications.  The patient's obstetrical history included one previous pregnancy with abortion at eight weeks in 2007. Th patient had no family history of major congenital malformation (MCM). The patient's last menstrual period (LMP) date was 16-Apr-2020 and estimated delivery date (EDD) was 21-Jan-2021.  On 19-Sep-2020, at gestational age of 21 weeks and two days, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, indication: not reported) (explicitly coded as vaccine exposure during pregnancy'). The batch number was 276547 and expiry date was 27-Jun-2021.   On 20-Sep-2020, one day after receiving Flucelvax QIV, the patient experienced mild injection site soreness.  On 22-Sep-2020, the patient recovered from event of 'vaccination site pain'.  Additional information received on 13-Oct-2020 from other non-health professional (consumer): Patient's LMP and EDD provided. Patient's obstetrical history provided. It was confirmed that the patient had no family history of MCM. Route of administration, anatomical location, batch number and expiration date of Flucelvax QIV provided. Two concomitant medications added. Event 'vaccination site pain' added. Case outcome updated from 'not reported' to 'resolved'. Narrative amended accordingly.  Company comment: The event of 'vaccination site pain' is assessed as related, while the event of 'vaccine exposure during pregnancy' is assessed as not related to Flucelvax QIV.; Sender's Comments: The event of 'vaccination site pain' is assessed as related, while the event of 'vaccine exposure during pregnancy' is assessed as not related to Flucelvax QIV.
11.5 hours after my first Moderna injection (at 1:30am), I began experiencing extreme chills and I could not warm up. At some point in the middle of the morning, around 4 or 5am, I felt extremely feverish and lethargic. I was barely able to get out of the bed. The remainder of the day, my body felt so weak, as if I exercised for 4 hours the day before. I was sweating a lot and trying to maintain my body temperature the whole day. My temperature was 101.5 when I checked it at night. Around 1:30 am, I started feeling better. The next day, my body temperature was normal but I was still sweating more than usual. Today, I am feeling a little weak but much better than the past couple of days.
swelling & hot to touch rt arm redness down to elbow; mom gave APAP;
h/a w/sl fever 1st day 4JUN92 t102-104.4; broke out on forehead & 5JUN92 chin w/pimple-like rash; low grade fever only 99t;
Suspected Vaccination failure; Got shingles in October 2020; This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In October 2020, less than 2 years after receiving Shingrix and unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the 2nd dose of Shingrix in 2019. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles were unknown at the time of reporting. The reporter agreed to follow up from GSK.
Potential Wrong Route of Administration; Circumscribed red area around injection site; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included lipoma.   On 12th December 2019, the patient received the 1st dose of Shingrix. On 12th December 2019, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. In December 2019, the patient experienced injection site erythema. On an unknown date, the outcome of the intramuscular formulation administered by other route and injection site erythema were unknown.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional case details were reported as follows: This case was reported by patient himself. The patient received a dose of Shingrix in left arm where he has a superficial lipoma. The patient thought that the dose was administered into the lipoma instead of the muscular tissue, which led to intramuscular formulation administered by other route.  He noted there was a circumscribed area around the site which was red, but he did not feel the injection at all.  The reporter consented to follow up.  No further details were provided at the time of the call.
On 03/01/2001 the patient experienced jerking of shoulders, shaking of head, seeing light and dark spots and saying "my head itches". The patient was seen in the ER on 03/02/2001, examined and released. No treatments or medications were prescribed. On 03/09/2001 the patient's symptoms were more persistent. The patient was scheduled for a CT of the brain. No further details were provided. Additional information has been requested.
A spontaneous, non-serious event of tested positive for Flu B has been received from a certified medical assistant, concerning a four-year-old female patient subsequent to FLUMIST use. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 54 months of age for FLUMIST. On 04-Oct-2009, the patient received FLUMIST. On 06-Oct-2009, the patient presented the doctor's office with fever. The patient tested positive for influenza B. The outcome of the event was unknown.
Coughing; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (Coughing). At the time of the report, COUGH (Coughing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient asking  Is coughing a side effect . No concomitant medications were provided by reporter. No treatment details were provided by reporter.  Denied to be followed by safety
About 8 days after the first dose, the vaccine site started welting up  and I now have a large rash that is hot and itchy
Weakness, arthralgia, not herself, fever after vaccination, wt loss 6 (P).
myocarditis following SARS-CoV-2 vaccination; This is a literature report. This author reported similar events for five patients. This is the third of five reports.  An adult male patient (age range 20-25 years) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not have an infectious prodrome. The patient developed severe chest pain and elevated troponin I. The patient developed CMR-proven myocarditis shortly after vaccination. The patient experienced myocarditis following sars-cov-2 vaccination, 2 days after the second vaccination. Lag between vaccination and presentation: 2 days. Symptoms at presentation included non-positional chest pain radiating to back; myalgia and; malaise. The patient had fever on presentation. Electrocardiogram showed sinus rhythm with diffuse ST elevation and PR depression; non-sustained ventricular tachycardia. Peak cardiac troponin 1 was 13.4 ng/mL. Ejection fraction (normal >55%) was 48%. The patient had negative nasopharyngeal SARS-CoV-2 PCR testing. CMR revealed patchy midmyocardial increased T2 signal with corresponding late gadolinium enhancement consistent with the acute inflammation of myocarditis. The patient did not develop any other complications and was discharged home. The outcome of the event was unknown.   Although the clinical presentation, CMR findings, and temporal association strongly suggest the possibility of vaccine associated myocarditis in the patient, the authors cannot conclude definitively that COVID-19 vaccine was causative or that other etiologies for myocarditis can be definitively excluded in the patient. Nevertheless, clinicians should be suspicious of myocarditis in recently vaccinated patients with symptoms consistent with this diagnosis.  No follow-up attempts are possible; information about the lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information, the known safety profile and the temporal association of BNT162B2 administration to the event, a possible contribution of the drug to the event cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202100999284 same article/drug/event, different patient