chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approx. 2 hours after vaccination the administration site became red and swollen. At approximately 24 hours the redness and swelling had extended to the elbow. Pt reports warmth as well. No anaphylactic symptoms present. Advised pt to seek medical care if swelling continues to progress down the arm or if she develops any difficulty breathing or other symptoms of anaphylaxis.
received doses from vials that had exceeded the 30 day refrigeration limit; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received doses from vials that had exceeded the 30 day refrigeration limit) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received doses from vials that had exceeded the 30 day refrigeration limit). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received doses from vials that had exceeded the 30 day refrigeration limit) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Fever; Myalgia; Pain in hip; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever), MYALGIA (Myalgia) and ARTHRALGIA (Pain in hip) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PYREXIA (Fever), MYALGIA (Myalgia) and ARTHRALGIA (Pain in hip). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever), MYALGIA (Myalgia) and ARTHRALGIA (Pain in hip) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use was not provided by reporter.
Generalized rash beginning around 4pm - patient describes as hives. Angioedema begin about 11pm same day as vaccination and lasted to early next morning.  Patient took Benadryl, Sudafed, Pepcid and Zyrtec.  Rash gone in 2 days.
Positive fever/chills - 100.2 degrees, body aches. Injection site was red, hot & swollen. Patient felt like her heart was racing and pulse rate was high and HA.
This spontaneous report was received from a back office lead and refers to a 33 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 26-MAR-2016, the patient was vaccinated with the improperly stored dose of RECOMBIVAX HB (1 ml, intramuscularly in right deltoid, lot # reported as L042856 (verified to be non-valid), expiration date 15-SEP-2017). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information is not expected as all the correspondence was returned by the post office.
History of Present Illness:  This is a 84y.o. female with past medical history significant for history of GI bleed, HTN presents to the hospital with hematochezia noted at nursing facility. Patient is a poor historian, A/O ×1 to self only and unable to provide significant history. History was supplemented upon chart review and discussion with patient's daughter over the telephone. She states that the patient was recently hospitalized at Hospital for hypertensive emergency with adjustments made to patient's oral antihypertensive regimen. Following hospitalization, patient was discharged to care of where patient was being treated for presumed bacterial pneumonia with antibiotic therapy and antitussive therapy. Patient was noted to have bright red blood in her stool today at the nursing home prompting evaluation within the ED. Patient's daughter unaware of any significant hematochezia, melena, hematemesis. Patient's daughter states that prior to hospitalization, she was A/O ×3 and independent with all activities of daily living. Since hospitalization, patient has had an abrupt decline in her mentation, A/O ×1-2. Upon chart review, patient was evaluated at hospital on 10/2020 for acute GI bleed with colonoscopy and EGD demonstrating pandiverticulosis, hemorrhoids, esophageal mass measuring 7×7 mm, GE junction ulcer measuring 10×10 mm, gastric atrophy, deformed pylorus. Unfortunately unable to locate the results of pathology on chart review and patient's daughter unaware of results at this time. Patient also completed vascular surgery evaluation for questionable intramural hematoma involving the infrarenal abdominal aorta, unclear of any acute intervention or need for outpatient follow-up. Evaluation in the ED, vital signs initial BP 134/76, RR 18, HR 99, afebrile, stable SPO2 on room air. Workup significant for normocytic hypochromic anemia, hemoglobin 6.7, 1 unit PRBC to be transfusion repeat hemoglobin thereafter. Suspect CTD at baseline, creatinine 1.43 on prior admission at Facility receiving in 10/2020, creatinine of 1.10 on admission today. Incidentally found to be covert positive, chest x-ray demonstrating left basilar atelectasis, 2/2 Pfizer vaccine completed. Patient to be admitted to internal medicine with consult placed to GI given hematochezia and prior endoscopic history.
This spontaneous report as received from a consumer as part of a marketing research program conducted by agency, refers to a male patient of unknown age. On an unknown date, the patient was vaccinated with MMR II (dose, route, lot # and expiration date were not reported). On an unknown date, the patient experienced MMR II as a child. The patient's outcome was unknown. The relatedness between the vent and MMR II was unknown. Additional information is not expected as the reporter did not wish to be contacted.
High Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (High Fever) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) CF. In 2021, the patient experienced PYREXIA (High Fever). At the time of the report, PYREXIA (High Fever) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  No treatment information was provided by the reporter. 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.   This case was linked to MOD-2021-624854 (Patient Link).   Reporter did not allow further contact
Hives; Rash all over my body; itching; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EM9809, expiry: unknown), via an unspecified route of administration on 03Feb2021 at a single dose for covid-19 vaccination; diphenhydramine hydrochloride (BENADRYL), via an unspecified route of administration from an unspecified date at 25 mg about every 4 hours for an unspecified indication;  and prednisone, route of administration, start and stop date, and dose were not reported for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient got the first Pfizer vaccine on 03Feb2021 and did not have any reaction until Tuesday night. Early Wednesday morning of this week (10Feb2021), the patient started with hives and a rash all over the body and the patient started with some oral Benadryl 25 mg about every 4 hours which did nothing and then on Wednesday night, the patient had to take some oral Prednisone and that was about 10:30 Wednesday night and the hives continue to get worse and about 1 o'clock in the morning Thursday the 11th, the patient took another 20 mg and then Thursday evening along with the Benadryl, the patient took 40 mg together for the hives and itching. Today, the patient was able to get in with a primary care doctor and she put the patient on a Prednisone dose pack for 6 day and to switch from Benadryl to Zyrtec (Intent: treatment) 1 tablet twice a day for the itching and the hives. The patient wanted to know if there are reports of hives starting this late after having the vaccine. The action taken in response to the events for diphenhydramine hydrochloride and prednisone was unknown. The outcome of the event hives was not recovered while the other events was unknown.
Patient felt dizzy at time of injection. Patient was given cool compress for face and neck. Came in day after  injections with swollen and red left arm, red right arm. Patient stated he had been taking ibuprofen. Pharmacist recommended adding a cold compress to area.
Pneumovax injection given in right deltoid and had erythema, pain. edema from shoulder to the elbow. (OMIC)
Swollen right arm Arm pain radiating from shoulder to wrist Fever 101.0
mom called, 8/13/19 at 220pm to report that area surrounding the vaccination was red, swollen and warm to the touch, itchy, and tender to touch, afebrile. Nurse suggested ibuprofen for pain and inflammation and cold compress.  mom ok with monitoring. Mom called on 8/14/19 to report no improvement to Left arm, still afebrile but this writer suggested patient come in for evaluation of  site and out of concern for secondary infection.  Patient was examined by the doctor and recommended cool compress/ice, SARNA for itch, benadryl PRN, close monitoring for fever, increased pain and recommended Td in the future. outcome pending.
Adverse effect of other bacterial vaccines, subs encntr on 2017-06-16.
This spontaneous report was received from a registered nurse and refers to a 12 month old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 20-OCT-2016 (also reported as 20-OCT-2018), the patient was vaccinated with an improperly stored PROQUAD lot # M022402 with expiration date of 01-NOV-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 23 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1705USA013888:
Patient developed hives on face, abdomen, arms, and legs the evening of day of immunization. Some edema of hands and feet. Temperature 99-100 degrees Fahrenheit. Benadryl and Ibuprofen given over next 2.5 days. Symptoms resolved on beginning of third day without residual effects.   Per mother, private physician recommended no immunizations for 6 months.
On the third night after I received my second Moderna Vaccine , I broke out in hives under my breasts . I had nothing out of the ordinary , just the vaccine.  I took benedryl for 2 days and then they were gone. I did not seek medical treatment .
This spontaneous report as received from a registered nurse refers to a 12 months old male patient. The patient was inadvertently vaccinated with 0.65 ml ZOSTAVAX on left thigh (lot# reported as H018091, expiry date on 04-JAN-2014) instead of VARIVAX (Merck) on 06-DEC-2012. Route was unspecified. Concomitant medications included hepatitis A virus vaccine (manufacturer unspecified), M-M-R II and influenza virus vaccine (manufacturer unspecified). No adverse effects reported at this time. This is one of several report received from the same source, 1212USA004226. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 24Apr2021 as dose 1, single (Lot number: EW0176), in left arm and on 15May2021 as dose 2, single (Lot number: EW0183) at the age of 58 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 29Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 02May2022 as dose 4 (booster), single (Lot number: 056A22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High bp" (unspecified if ongoing), notes: High bp; "high cholesterol" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Anti-viral details product COVID 19 Treatment, brand Paxlovid, treatment start date 08Jun2022, treatment stop date 12Jun2022, indication Treatment of COVID-19. Was the patient taking any other medications, products within 2 weeks of starting COVID-19 treatment was reported as yes. the patient previously receive a COVID-19 Vaccine was reported as yes. Reported Event: Runny nose and sneezing. Antigen Rapid Test for COVID-19 that was positive. known allergies was reported as No.
Confusion, Headache, Myalgia, Arthralgia, fatigue Narrative:
dizziness within 5 minutes, pt moved to chair with arms against wall for support. blood pressure continued to drop and and dizziness increased until pt lost consciousness. Epinephrine administered which resulted in pt becoming alert, once alert pt was given 15ml of hydroxyzine 10mg/5ml and pt then stabilized. pt left with paramedics about 15 minutes later
This spontaneous report was received from a physician and refers to a 19 years old female patient with attention deficit/hyperactivity disorder, and without drug reactions or allergies. The physician reported that on 12-AUG-2014, the patient was vaccinated with the first dose of GARDASIL, 0.5 ml, intramuscular, (anatomical location, lot number and expiration date were not provided), and then on 10-AUG-2015, the patient was vaccinated with the second dose of GARDASIL, lot # L007531, 0.5 ml, intramuscular, (anatomical location, and expiration date were not provided). Concomitant therapies included ADDERALL. The physician stated that the patient was seen in his office on 18-AUG-2015 due to a high fever, ranging from 104 degrees F to 106 degrees F. It was also reported that the patient was seen every day from 18-AUG-2015 through 21-AUG-2015, because she was very sick. Additionally, multiple laboratory tests were performed during those visits, which included on 18-AUG-2015, complete blood count (CBC), an Epstein Barr viral panel and C-reactive protein, and on 20-AUG-2015, a CBC,  cytomegalovirus antibody titer and a liver panel, the results were not provided. Subsequently, the patient was diagnosed with mononucleosis, and was prescribed ibuprofen as treatment for the fever. The outcome of mononucleosis was reported as not recovered. The relatedness between mononucleosis and therapy with GARDASIL was not reported. No product quality complaint was involved. The reporter considered mononucleosis to be serious due to disability, because the extreme fatigue was preventing the patient from attending college classes. This is one of two reports received from the same reporter. Additional information has been requested.
Increase heart rate indicated by Apple Watch.  Highest recorded was 148 BPM and it slowly decreased over a period of 3 hours back to normal.  No other issues noticed at the time such as shortness of breath, chest pains, dizziness, etc.
Menstrual cycle came on 10 days early, extremely heavy and lasted for twice as long as normal.  Also severe dizziness started 48 hours after vaccine and has not subsided.
Mom states child had vaccines (11/3/09). Site was red & swollen and 2 days later bumps (circular red raised) came up on legs, especially her left leg.
Tiredness loss of consciousness fainting vomiting dizziness a lot of body ache headache tiredness physical exhaustion shortness of breath, no appetite, hospitalization due to loss of consciousness and severe headache even now I have a headache and fatigue is sometimes unbearable.
This case was reported by a pharmacist and described the occurrence of nodule injection site in a 3-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline). Concurrent medical conditions included chronic pulmonary disease, prematurity (born at 23 weeks gestation), reflux (unknown) and retinopathy of prematurity. Concurrent vaccination included pneumococcal vaccines (non-GSK); Wyeth Labs; unknown, unknown given on 18 June 2013. Concurrent medications included CHOLECALCIFEROL, Atropine, EES, Gatifloxacin, Multivitamin with iron and PRED FORTE. On 18 June 2013 at 13:54 the subject received 1st dose of PEDIARIX (.5 ml, unknown route, right thigh). On 19 June 2013, 1 day after vaccination with PEDIARIX, the subject experienced nodule injection site. The pharmacist described the nodule as large. The subject was in the neonatal intensive care unit at the time of reporting. The pharmacist reported that the immunization series was not discontinued or delayed. The pharmacist considered the event was disabling. At the time of reporting the event was improved. The pharmacist reported 4 other cases. See cases A1033993A, A1033995A, A1033996A, and A1033997A for details on the other cases.
Information has been received from a registered nurse, concerning a 22 year old female patient with psoriasis, anxiety, myopia, sebaceous cyst and "bumps on skin", as concurrent conditions since unknown dates; no previously drug reactions and no allergies reported. The patient's concomitant medications included tacrolimus, fluocinolone, clindamycin, citalopram, benzoyl peroxide, DIFFERIN and albuterol. On 15-JUN-2018, the patient was vaccinated with M-M-R II one dose subcutaneously, lot number N024696 with expiration date on 07-APR-2019 (albumin status, strength and anatomical location were not provided), for prophylaxis. On the next day, the patient developed lymphadenitis; the patient sought medical attention and was saw by a physician at an urgent care clinic. The following laboratories were performed without results provided: sedimentation rate, complete blood count with differential, mumps immunoglobulin (IGM test) and mono test. Patient received an unspecified treatment for the adverse event. The reporting nurse stated that the patient was "doing better" at the time of the report and considered lymphadenitis to be related to M-M-R II, since it could had been caused by the mumps component of the M-M-R II.
Stomach cramps. Vomiting 6 hrs after 4th/last pill. Symptoms disappeared.
Patient was administered with vaccines that had undergone temperature excursion; Patient was administered with vaccines that had undergone temperature excursion; This spontaneous case was reported by a medical assistant and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that had undergone temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that had undergone temperature excursion) in a 20-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that had undergone temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that had undergone temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that had undergone temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that had undergone temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 30-Jan-2022, the patient received the booster dose of Moderna COVID-19 Vaccine. No concomitant medications were reported.   Vaccines were thawed on 28-Jan-2022.  It was reported Maximum or minimum temperatures reached as on 28-Jan-2022 temperature range positive 34.7 F to positive 41.2 F, on 30-Jan-2022 temperature range positive 34.7 F to positive 41.2 F which occurred for 48 hours. On 31-Jan-2022 temperature range positive 34.7 F to positive 41.2 F for 12 hours and on 04-Feb-2022 temperature range positive 35.2 F to positive 41.7 F for 12 hours.  It was reported that the patient did not experience any adverse event.  No treatment medications were provided.   This case was linked to MOD-2022-539812 (Patient Link).
Information has been received from a licensed practical nurse concerning a 16 year old male patient, with autistic disorder and no known drug allergies, who on 08-AUG-2011 was vaccinated with a first dose of 0.5 ml of GARDASIL (lot # 669308/0636AA, expiration date unknown, route not reported). There was no concomitant medication or vaccines. The licensed practical nurse reported that on 08-AUG-2011 the patient experienced temporary loss of peripheral vision (the reporter did not know if it was total loss or just decreased vision loss) and headache. The adverse events did not develop until that evening after the patient returned home from football practice. The reporter did not know if any trauma was sustained during practice, but assumed the mother would have said something if it had occurred. At the time of the report no testing was done, no treatment was provided, the event was not disabling or life threatening and the patient sought unspecified medical attention. On 09-AUG-2011 the patient recovered from vision loss and the headache persisted. The licensed practical nurse could not provide any environmental details (temperature, whether patient had eaten, etc). Upon internal review, total vision loss was determined to be an other important medical event. Additional information has been requested.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided.  On an unknown date the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX lot # N032103 expiration date 11-FEB-2019 (strength, dose, frequency were not reported), subcutaneously for prophylaxis. No adverse effects were reported in the patient.