chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 61 year old male with thyroid disorder and gastrooesophageal reflux who on 14-DEC-2010 was vaccinated with ZOSTAVAX (Merck) (lot # not reported). Concomitant therapy included PREVACID and SYNTHROID. Subsequently the patient developed shingles after administration of ZOSTAVAX (Merck). Specifically, a rash developed 1 week after vaccination on 21-DEC-2010, then on 04-JAN-2010 the patient visited the physician office and showed classic symptoms of shingles with left flank abdominal rash and neuropathic symptoms. The patient did not recover. Additional information has been requested.
Passed 83 days without second days (Never receive the second dose); This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Passed 83 days without second days (Never receive the second dose)) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Passed 83 days without second days (Never receive the second dose)). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Passed 83 days without second days (Never receive the second dose)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided by reporter.
excess energy; seemed to make him stronger; This is a spontaneous report from a contactable consumer reported for himself. A 71-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EL9262; Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 08Feb2021 (at the age of 71-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing controlled high blood pressure (has had this forever), ongoing high cholesterol (takes medication for this). The patient previously received shingles vaccine and flu vaccines in past, but no events reported for those vaccines. The patient previously took first dose of BNT162B2 (Lot Number: EK4176) on 19Jan2021 10:45 (at the age of 71-year-old) for covid-19 immunisation and experienced the same as dose 2, an increase in energy. There were no concomitant medications. Additional vaccines administered on same date of the Pfizer suspect; prior Vaccinations (within 4 weeks); AE(s) following prior vaccinations included none. The patient experienced excess energy and seemed to make him stronger on unspecified date in Feb2021. Patient had both injections and was wondering did anyone report excess energy after the shots. It was noted that he had this experience after the shot. He was walking 2-3 miles and works out every day. After the first vaccine he had the same experience, an increase in energy. There were no other side effects, just excessive energy where he always wanted to be up and going. Caller explained he never had anything like this happen after a vaccine. He had no sore arm and no side effects at all, no headache, nausea, feeling bad. The product seemed to make him stronger and given him so much energy. The product had him up at 8am, making him want to work in his yard, lift weight where he had been able to increase his repetitions, it made him stronger he feels like. He told all his friends so they can get it; he remarked they should put it in a shake. Events did not result in emergency room or Physician office visit. Clinical outcome of event was not recovered.  Follow-up attempts completed. No further information expected.
NO SIDE EFFECTS, WE VACCINATED THE PATIENT WITH THIS LOT NUMBER: FL2757, THIS LOT WAS RECLLED BY PFIZER DUE TO EXPIRATION DATE, BUT ACCORDING TO THEIR RECOMMANDATION , PRODUCT EXPIRES 10 WEEKS AFTER RECEIVING OUR VACCINE EXPIRES ON 10/21/22,
The differential diagnosis for this patient's chest pain includes PE, ACS, Dissection, Pericarditis, Pneumothorax, Pleurisy, Pneumonia and musculoskeletal strain. Given the above history, physical exam and ancillary tests, the patient's symptoms are most consistent with:  Acute myopericarditis.  Should be noted the patient is post 2nd COVID 19 vaccine by  3 days ago.  Case reviewed with the pediatric emergency medicine physician at healthcare facility who will accept the patient in transfer.  Because this is highly likely a post vaccination myopericarditis will hold on aspirin or other treatments at this time.  Patient was given Motrin 400 mg p.o. in the ED for pain.
- felt like there was a cotton ball stuck in back of throat -constriction on right side of chest radiating from shoulder into right lung - burning and freezing sensation in  right arm and shoulder - symptoms would come and go over the course of 3 hours
pt devel itchy rash, hives 24OCT-nausea;felt as if had the flu-swelling gradually improved-notified RN on 25OCT-said is not able to eat some-rash nearly gone-dry mouth;
Chills, fever, and headache.  This lasted 2 days.  Ten days later, fever and headache returned for one day.  Took rapid COVID test---negative.
Burning throat; Burning mouth; Bad taste in the mouth; "feel like a head cold"; Flu like feeling; Fatigue; Achiness; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (Burning throat), ORAL DISCOMFORT (Burning mouth), TASTE DISORDER (Bad taste in the mouth), NASOPHARYNGITIS ("feel like a head cold") and INFLUENZA LIKE ILLNESS (Flu like feeling) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Ringing in ears in 2020. Concomitant products included CARIPRAZINE HYDROCHLORIDE (VRAYLAR) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like feeling), FATIGUE (Fatigue) and MYALGIA (Achiness). On an unknown date, the patient experienced THROAT IRRITATION (Burning throat), ORAL DISCOMFORT (Burning mouth), TASTE DISORDER (Bad taste in the mouth) and NASOPHARYNGITIS ("feel like a head cold"). At the time of the report, THROAT IRRITATION (Burning throat), ORAL DISCOMFORT (Burning mouth), TASTE DISORDER (Bad taste in the mouth) and NASOPHARYNGITIS ("feel like a head cold") outcome was unknown and INFLUENZA LIKE ILLNESS (Flu like feeling), FATIGUE (Fatigue) and MYALGIA (Achiness) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered THROAT IRRITATION (Burning throat), ORAL DISCOMFORT (Burning mouth), TASTE DISORDER (Bad taste in the mouth) and NASOPHARYNGITIS ("feel like a head cold") to be not related. No further causality assessments were provided for INFLUENZA LIKE ILLNESS (Flu like feeling), FATIGUE (Fatigue) and MYALGIA (Achiness).    Additional concomitant medications included unspecified BP medications.  No treatment was received.
Information has been received from a medical assistant referring to a 6 month old female patient. No relevant medical history or concurrent conditions were reported. On 08-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original reports is MARRS#1507USA011322. Additional information has been requested.
Fatigue; Lack of energy; Pain in left arm (vaccine arm); This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 27Apr2021 at 11:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included iron supplements (MANUFACTURER UNKNOWN) and mushroom immunity supplements (MANUFACTURER UNKNOWN); both for unknown indications from unknown dates and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: PAA165969) via an unspecified route of administration in the left arm on 05Apr2021 at 11:30 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. On 27Apr2021 at 13:00, the patient experienced fatigue and lack of energy for about 24 hours after the vaccine and had pain in left arm (vaccine arm). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fatigue and lack of energy were resolved on 28Apr2021; while that of the event pain in left arm (vaccine arm) was resolved on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Pt reported that on 10/13, pt had dizziness post vaccination but it improved quickly.  Several hours later, pt developed itchy eyes. 10/15 pt had an UC Tele visit where pt reported bilateral, red more itchy eyes swollen w/forehead HA with "numbness". Pt was advised at that time that it was unlikely allergy to moderna since no widespread hives/sob/wheeze/dysphagia/stridor.  Rx: zaditor/zyrtec/benadryl for all conj and f/u pcp if fti On 11/2 and 11/3 pt was seen for persistent body rash w/ itchiness that developed ~24hrs after Moderna COVID Vaccine, including bumps under the patient's neck. Pt also reports 2 days of tingling on left side of face and tongue.  No Fever but + for chills.  Denies any itchiness or swelling in her throat or difficulty swallowing, or shortness of breath.  Pt prescribed prednisone taper in addition to the ketotifen, cetirizine, and diphenhydramine initially prescribed.
64 year old patients were given fluzone high-dose quadrivalent per their request when they declined fluzone qiv with no reported ae; Initial information received on 20-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 64 years old female patient who was given fluzone high-dose quadrivalent per their request when they declined fluzone qiv with no reported adverse event while receiving vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ELASOMERAN (MODERNA COVID-19 VACCINE).  On 19-Oct-2022, the patient received a dose of 0.7 ml suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ919AD) (Frequency: once ) (Strength: Fluzone HD ) (expiry date: 30-Jun-2023) (formulation was unknown) via intramuscular route in the right deltoid as prophylactic vaccination.  On 19-OCT-2022 the patient was given fluzone high-dose quadrivalent per their request when they declined fluzone qiv with no reported adverse event (Product administered to patient of inappropriate age) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Redness and swelling on left thigh noted today 9/17 and treated with cephalexin 125 mg/5 ml take 1 tsp 3 times a day and prednisone 15 mg/5 ml oral syrup take 3 times daily for five days.
Flu-like symtoms: Day following injection, Headache 7:00AM-2:00PM, whole body muscle and joint aches 7:00AM-6PM, shivering 7:00AM-7PM, tiredness 7:00AM-10PM, stomach upset 7:00AM-7:00PM.
Awakened severe shortness of breath, chills, muscle shakiness and pain, nausea, vomiting
Chills; Injection site pain; Myalgia; Pyrexia; This case was received via FDA VAERS (Reference number: 0917261) on 02-Mar-2021 and was forwarded to Moderna on 02-Mar-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of CHILLS (Chills), INJECTION SITE PAIN (Injection site pain), MYALGIA (Myalgia) and PYREXIA (Pyrexia) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 01-Jan-2021, the patient experienced CHILLS (Chills), INJECTION SITE PAIN (Injection site pain), MYALGIA (Myalgia) and PYREXIA (Pyrexia). At the time of the report, CHILLS (Chills), INJECTION SITE PAIN (Injection site pain), MYALGIA (Myalgia) and PYREXIA (Pyrexia) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other Meds : Novolog (insulin pump) levothyroxine, atorvastatin Symptom Text : Pain at injection site, myalgia, chills, fever,   Reporter did not allow further contact
Information has been received from a pharmacist referring to multiple unspecified patients of unknown age and gender. There was no concomitant medication, pertinent medical history or drug reaction reported. On unspecified dates, the patients were administered improperly stored ZOSTAVAX vial 19,400 (plaque-forming units) PFU (dose, route, Lot number and expiration date were not reported). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1612USA012829.
chills, body ache, soreness in body, light headache that went away w/ibuprofin, a few short dizzy spells, tired and loss of appetite.   no fever but face was hot, body was cold.   symptoms started about 9hrs after the shot, which was my second dose(1st shot no symptoms) and went away for the most part the next day.  I was still a little sore in lower back the day after the shot and was tired by the end of my work day.  3rd day back to normal.
doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021 at 2:05 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 2:05 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 69.60 for dose administered on 02-Mar-2021 and 69.68 for dose administered on 30-Mar-2021. No concomitant product reported by reporter.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. Patient received poor quality vaccine on 02-Mar-2021 at 02:05 PM and on 30-Mar-2021 at 02:05 PM. Batch number 014M20A underwent multiple temperature excursion on 02-Mar-2021 from 27 to 36 degrees Fahrenheit from 09AM to 03 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 02-Mar-2021. Batch number 019B21A underwent temperature excursion on 30-Mar-2021 with temperature 33 degrees Fahrenheit at 09AM. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 30-Mar-2021. No treatment medication were provided.
SWOLLEN ARMPIT; SORE ARM; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced sore arm. On 07-APR-2021, the subject experienced swollen armpit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen armpit, and sore arm. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Meniere's Disease- increased symptoms of ear congestion, hearing loss, tinnitus, right ear
Information has been received from a female consumer who was vaccinated with a dose of ZOSTAVAX (Oka/Merck).  The patient developed blisters all over her body 4 days after getting the vaccination.  The outcome was unknown.  It was not specified if the patient sought medical attention or not.  No further information is available.
an expired dose of TENIVAC was administered to a patient, with no reported adverse event; Initial information received on 07-Mar-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 67 years old male patient who received an expired dose of diphtheria-2/tetanus-5 adsorbed toxoid no preservative adult [Tenivac], with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CNJ 20V (CRM197) (PREVNAR 20).  On 07-Mar-2023, the patient received 0.5 ml dose of suspect diphtheria-2/tetanus-5 adsorbed toxoid no preservative adult, Suspension for injection (strength - standard, frequency - once, lot - U6922AA, expiry date - 22-Jan-2023) via intramuscular route in the right deltoid for immunization.  On 07-Mar-2023 the patient received expired dose of tenivac with no reported adverse event (expired product administered) (latency: same day)  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sharp pain in left ribs/under armpit; Sharp pain in left ribs/under armpit; This is a spontaneous report from a non-contactable consumer, the patient. A 20-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 17Mar2021 at 13:15 (at the age of 20-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to penicillin. Concomitant medications were not reported. Prior to 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 4 weeks prior to the COVID vaccine. On 18Mar2021 at 14:30, the patient experienced sharp pain in left ribs and under armpit, located under same arm where shot was given. The events resulted in emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of events rib pain and armpit pain was recovered with sequelae at the time of this report.   No follow-up attempts are possible. Information about lot number cannot be obtained.
Sick; This is a spontaneous report from a contactable consumer or other non health care professional. A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient also received tofacitinib citrate (XELJANZ XR, Batch/Lot Number: EE7546, oral) from an unspecified date to an unspecified date, at 11 mg, 1x/day for an unspecified indication. The patient medical history included rheumatoid arthritis. Concomitant medications included alendronate sodium hydrate, budesonide, formoterol fumarate (SYMBICORT), meloxicam, pridinol mesilate (MELOXICAM - PRIDINOL TEVA), famotidine, sulfasalazine, all taken for unknown indications from an unknown date. The patient previously took aspirin and experienced allergy, penicillin g procaine and experienced allergy, enbrel and experienced allergy. It was reported that Patient advised that when she took the covid vaccine she became very sick and cold not take her meds for 7 days. The reporter assessed the event as non-serious. Reporter consider event caused by suspect product was not known. The action taken in response to the event for tofacitinib citrate was unknown. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient had swolen axial lymph node under injection arm, increased redness and swelling- softball size red welt observed by me on 6/6/21. Patient noted periodic blue streaks surrounding injection rash. Patient went to urgent care because redness was increasing in size. Patient also had fatigue and malaise.