chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presented to emergency department on 11/16/2021 from skilled nursing facility with epistaxis and coughing up blood. He was found to be COVID-19 positive at facility. He was found to have thrombocytopenia and hypernatremia. He was evaluated for monoclonal antibodies, but became hypoxic before administration and required supplemental oxygen. He was admitted for further management. He was treated with dexamethasone. Patient's condition did not improve and the decision was made by family to make comfort measures only. Patient expired on 11/28/2021
One week later arm swelled up in a red bump, with mild itching and now sight is red where itching accured
I went from working a full time job, to being in the bed everyday. I had to get the vaccine for a titer test and it crashed my entire immune system. I am still on many medicines and many specialist. I had to retire from my job of 20 years.  The amount of paper work to send to you would be over whelming to start. I will attach my recent diagnosis. I had hashimotos prior to the vaccine, now I have the following:   Diagnosis:  Pernicious Anemia ? Dr.  Celiac Disease-Dr.  Hashimoto?s -Dr.  Common Variable Immune Deficiency- Dr.  Dermatitis Herpetiformis/blistering disease ? Dr.  Factor V Leiden- Dr.  Autoimmune meta plastic atrophic gastritis- Dr.  Seronegative Rheumatoid Arthritis; Localized, Primary Osteoarthritis of the Ankle And/or Foot- Dr.  C Diff carrier- Dr.
Rash started at injection site and went down arm to wrist. Contacted family physician & was treated for shingles for 4 months.
Received Moderna #3 dose/booster at 9ooam. At 100pm she felt pain at the injection site. Took tylenol. Arm became inflamed, red, itchy, and swollen, and painful. Now has had residual tingling, numbness at left upper arm down to elbow.
Was given both doses. 2 months after the vaccine I began experiencing shortness of breath, trouble breathing, and sharp pains in my chest and what feels like my heart.
Fever of 101-103 for 2 days Large, painful, and itchy rash around vaccination site starting 3 days after vaccination.  It then spread the next day to the inner arm, away from the vaccination site and a large ( about 5 inches at largest point) formed not near the vaccination site.
SORENESS TO SITE BEGAN IMMEDIATELY. PT ATTEMPTED IBUPROFEN FOR FIRST FEW DAYS, THEN STOPPED (DID NOT WANT TO TAKE MEDICATION ROUTINELY). PT CONTACTED HEALTH CLINIC THIS MORNING (09/29/2017) REPORTING CONTINUED MODERATE SORENESS ("NOT SEVERE") AND SOME WEAKNESS TO LEFT HAND (DESCRIBED AS SIMILAR TO THE WEAKNESS AFTER IT FALLS ASLEEP AND BEGINS TO WAKE (NO TINGLING/PRICKLING FEELING).
This is a spontaneous report from a non-contactable nurse (patient). This 22-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) 1st dose on 21Dec2020 10:00 AM at left arm, and 2nd dose on 11Jan2021 07:45 AM at left arm, both at single dose via an unknown route for COVID-19 immunization. Facility type vaccine was hospital. Medical history was not provided. Patient did not have COVID prior vaccination. Concomitant drug in two weeks included polycarbophil calcium (FIBER). Patient did not have other vaccine in four weeks. No COVID tested post vaccination. Patient's left armpit had an aching pain with movement or palpation. It was also swollen. She thought her lymph nodes were swollen. Event onset date was reported as 12Jan2021 05:00 AM. This also happened with first dose and it lasted for two weeks. No treatment received. Outcome of the events was resolving. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
flu like symptoms for 3 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms for 3 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms for 3 days). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms for 3 days) had resolved.            No concomitant and treatment medications were provided
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. The patient's medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored PROQUAD (lot # M017335, expiration date 05-OCT-2017, therapy type rHA; lot # M011662, expiration date 08-SEP-2017, therapy type rHA; dose and route not reported). The vaccine was improperly stored in 3.3 Celsius degree for 3 hours and 22 minutes. There were no previous exposures. Data logger was involved. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information is not expected as no consent to contact the physician.
This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a female patient who received ENGERIX B. Co-suspect products included ENGERIX B and ENGERIX B. On an unknown date, the patient received the 1st dose of ENGERIX B, the 2nd dose of ENGERIX B and the 3rd dose of ENGERIX B. On an unknown date, unknown after receiving ENGERIX B, ENGERIX B and ENGERIX B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter considered the therapy non-responder to be related to ENGERIX B, ENGERIX B and ENGERIX B. Additional details were provided as follows: The age at vaccination was not reported. The patient received 3 dose series of ENGERIX B and completed the series. The patient underwent blood titer which came back negative, which led the patient to be a therapy non-responder. The patient's physician ordered 4th dose and the health care professional administered the patient a 4th dose of ENGERIX B after the titer was performed. The health care professional did not have patient's date of birth and vaccine information was not available.
pt recv vax 16SEP96 & had petit mal sz;26SEP grand mal sz;27SEP hosp over noc-eval by neurologist;pt also c/o rt sided numbness;no fever r/t sz;
Stiff and sore right arm when lifting arm above shoulder.; sore right injection site arm after second shot/Stiff and sore right arm when lifting arm above shoulder.; Stiff and sore right arm when lifting arm above shoulder.; Inappropriate schedule of vaccine administration; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Stiff and sore right arm when lifting arm above shoulder.), VACCINATION SITE PAIN (sore right injection site arm after second shot/Stiff and sore right arm when lifting arm above shoulder.), VACCINATION SITE INDURATION (Stiff and sore right arm when lifting arm above shoulder.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administration) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077C21B) for COVID-19 vaccination.     Previously administered products included for an unreported indication: JANSSEN COVID-19 VACCINE (Patient received her Johnson and Johnson covid-19 vaccine for her first vaccine Arm was sore and patient had a headache. Jansen lot number 1808978 Patient had a headache the first two days after the vaccine. Patient had a sore right arm.).    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administration). On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Stiff and sore right arm when lifting arm above shoulder.), VACCINATION SITE PAIN (sore right injection site arm after second shot/Stiff and sore right arm when lifting arm above shoulder.) and VACCINATION SITE INDURATION (Stiff and sore right arm when lifting arm above shoulder.). On 18-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administration) had resolved. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Stiff and sore right arm when lifting arm above shoulder.), VACCINATION SITE PAIN (sore right injection site arm after second shot/Stiff and sore right arm when lifting arm above shoulder.) and VACCINATION SITE INDURATION (Stiff and sore right arm when lifting arm above shoulder.) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.
5 day of fever after getting his 1st dose of Pfizer Covid vaccine, associated vomiting, bilateral conjunctivitis, sore throat, lymphoadenopathy
This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 83-year-old male patient who received SHINGRIX (batch number ML532, expiry date 13th September 2020) for prophylaxis. Concomitant products included ALTACE and XARELTO. On 2nd June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 2nd June 2018, several hours after receiving SHINGRIX, the patient experienced injection site swelling. On 3rd June 2018, the patient experienced blotchy rash, itchy rash and erythematous rash. The patient was treated with BENADRYL. On an unknown date, the outcome of the injection site swelling, blotchy rash, itchy rash and erythematous rash were not recovered/not resolved. The reporter considered the injection site swelling, blotchy rash, itchy rash and erythematous rash to be related to SHINGRIX. Additional information was reported as follows: This case was previously not reported to anyone. The patient received the SHINGRIX vaccine in the left arm. The pharmacist reported that, on the day of reporting, the patient came back to the pharmacy and reported that, a few hours after receiving the SHINGRIX vaccine (on the day of vaccination, Saturday), he experienced swelling at the injection site. The reporter stated that, the patient on the next morning of the vaccination (Sunday) noticed a rash which went all the way down his left arm and into his groin area. On the day of reporting, the patient noticed that, the rash had spread to his forehead as well. The patient described the rash as blotchy, red and itchy. The patient had been using BENADRYL and reported to the pharmacist that the BENADRYL helped for a little while.
pt. recvd. vax & developed a rash typical of measles,cough,coryza,& conjunctivitis.
Allergic reaction, fever (104.6), tachycardic (+150 bpm), elevated blood pressure, difficulty moving extremities, severe pain, headache
Strong metallic taste in mouth; affects appetite; affects taste of food/drink; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the right arm on 06Apr2021 at 12:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN), naproxen sodium (MANUFACTURER UNKNOWN) and camphor, diphenhydramine hydrochloride, zinc oxide (BENADRYL) taken for unknown indication from an unknown start date within 2 weeks of vaccination. Prior to the vaccination, the patient was not 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 07Apr2021 at 13:00, the patient experienced strong metallic taste in mouth that had lasted for 16 hours and was continuing; not debilitating, but affected appetite and taste of food/drink. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events strong metallic taste and affects appetite were not recovered at the time of the report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
No signs or symptoms noticed until 7/24/20014 but mom wanted platelets checked before leaving for a trip abroad. Platelets on 7/22/14 were 12k without any bruising/petechiae/bleeds. He developed a bruise on 7/24/14 and platelets were 2k. He was then sent to Hospital and received IVIG x 1. CBCs to be followed weekly.
Syncope immediately following vaccination of Tdap, MENACTRA, and GARDASIL. Episode only lasted few brief seconds and pt recovered spontaneously without any treatment. Pt was observed in clinic for 20 minutes after event and discharged home without further issues.
Injection site reaction. Papules at site in circle approx. 3" in diameter.
Moderna COVID-19 Vaccine EUA I had to use 2 days of my PTO due to the side effects from the vaccine, which were: headache, fever, chills, body aches, joint paint, fatigue. I was in bed for 2 days with symptoms exactly like the flu. It was all I could do to crawl out of bed to go to the bathroom. This lasted from 6 pm on 3/17/21, to around noon on Saturday, 3/20/21. I did not expect the side effects to be that extreme.
This case was reported by a healthcare professional (nurse) and described the occurrence of swelling in a subject of unspecified age and gender who was vaccinated with BOOSTRIX (GlaxoSmithKline). On an unspecified date the subject received a dose of BOOSTRIX (unknown details). At an unspecified time after vaccination with BOOSTRIX, the subject experienced swelling, discomfort, soreness and tingling down arm (described as "tingling down arm to hand." It was unclear from the reporter if the events occurred at the injection site. No further details were provided at the time of reporting. At the time of reporting the outcome of the events were unspecified.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 12:00 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 24Mar2022 at 14:30 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's thyroiditis" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 01Aug2005. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective; patient was treated with PAXLOVID.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
no appetite; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (no appetite) and PYREXIA (Fever) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TREPROSTINIL SODIUM (REMODULIN) for Pulmonary arterial hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included MACITENTAN (OPSUMIT) and RIOCIGUAT (ADEMPAS) for an unknown indication.   On 25-Aug-2021, the patient started TREPROSTINIL SODIUM (REMODULIN) (Subcutaneous) .161 microgram/kilogram. 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 DECREASED APPETITE (no appetite) and PYREXIA (Fever). At the time of the report, DECREASED APPETITE (no appetite) and PYREXIA (Fever) outcome was unknown.            The patient experienced Headache with Remodulin and outcome reported was unknown. No treatment medication information provided.
not feeling really good; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A male patient received bnt162b2 (BNT162B2), administration date 12Dec2021 13:30 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: MALAISE (non-serious) with onset 13Dec2021, outcome "unknown", described as "not feeling really good".  Additional information: This is report 2 of 2.This report was not related to a study or programme. The Reporter was a Retired Registered Nurse who was also the patient's wife. The patient was administered Pfizer Covid-19 on 12Dec2021. Patient was not feeling really good today, but was not sick like reporter was; he didn't feel real good, but he didn't throw up.    Follow-up attempts are completed. No further information is expected.
No adverse events. Vaccine was administered to 16 year old. Approved for 18+
rapid heart rate; This is a spontaneous report from a contactable consumer (patient).  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number not reported, via an unspecified route of administration from an unspecified date as single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient would like to know if there's anything in the ingredients of the COVID vaccine that will stimulate the heart, she states she takes medication because she has a rapid heart rate. The patient states her niece received the second shot of the vaccine today and she didn't know that she should not take Tylenol or Ibuprofen and she took two Tylenol or Ibuprofen, patient would like to know if her niece should receive the second dose again. Patient heard that several people died after receiving the vaccine, she would like to know if this is true. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
11 days post vax pt had few tiny red dots & 40 min generalized tonic clonic sz (t=102); Required diazepam, Lorazepam & phenobarb to stop sz;
High cholesterol, depression, dry mouth, pain bone, pain joint, blood pressure high, heart attack, infract myocardial.  02/16/2007 MR received from PCP. First visit of 03/27/2006 appears to be F/U s/p AMI (Acute Myocardial Infarction) PCI (percutaneous coronary intervention) of the LAD, CFX, and PCA (Posterior descending coronary artery). Exam WNL. Visit 06/23/2006 HCVD (hypertensive cardiovascular disease), CAD.  Doing well.
mouth sore; arm sore; excessive fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A female patient (unknown if pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "PCV" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ORAL PAIN (non-serious), outcome "unknown", described as "mouth sore"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm sore"; FATIGUE (non-serious), outcome "unknown", described as "excessive fatigue ". Additional information: the patient received covid vaccine yesterday and reported mouth sore, arm sore and excessive fatigue today.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Rash developed hands and fingers on 08/02/2006.  Was seen at medical center emergency room later that day.  Discharged home without medication, no laboratory were done.
Child developed fever to 102 nest am and Henoch Schoenlein Purpura rash starting the next morning, and progressing to the point of not being able to walk the following evening, resulting in overnight hospitalization.
Patient arrived at Vaccine POD for 2nd dose of Pfizer and reported that after her 1st dose she had facial numbness on the right side of her face for 1 hour - about 4 hours after vaccine. Patient did not seek medical follow up. Symptom self resolved.
Started itching few hours after the 2nd dose. The patient broke out with hives later on in the evening. was treated with Benadryl
No adverse event; patient received a 0.3mL dose of the Moderna COVID-19 vaccine BIVALENT by intramuscular injection instead of the recommended 0.5mL dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (patient received a 0.3mL dose of the Moderna COVID-19 vaccine BIVALENT by intramuscular injection instead of the recommended 0.5mL dose) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .3 milliliter. In 2022, the patient experienced ACCIDENTAL UNDERDOSE (patient received a 0.3mL dose of the Moderna COVID-19 vaccine BIVALENT by intramuscular injection instead of the recommended 0.5mL dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (patient received a 0.3mL dose of the Moderna COVID-19 vaccine BIVALENT by intramuscular injection instead of the recommended 0.5mL dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (patient received a 0.3mL dose of the Moderna COVID-19 vaccine BIVALENT by intramuscular injection instead of the recommended 0.5mL dose).    No concomitant medications were reported. At least 5 adult patients received a 0.3mL dose of the Moderna COVID-19 vaccine BIVALENT by intramuscular injection instead of the recommended 0.5mL dose. These administrations occurred over the course of approximately 1 month.No symptoms were reported. No treatment medications were reported. This case pertains to Adult patient no.4.