chrisvoncsefalvay/vaers-outcomes huggingface dataset:
within 15 minutes of receiving vaccine, PT complained of swelling of throat and something stuck in throat. PT was administered 50 mg of Benadryl, 0.3 mg of epinephrine. 911 was called and pt. transferred to ED.
This spontaneous report was received from a nurse and refers to unspecified number of patients of unknown age and gender. No pertinent medical history, drug reactions or allergies and concomitant medications were reported. On unknown dates, the patients received doses of improperly stored GARDASIL, lot # J003727, expiration date 07-NOV-2015 (dose, route of administration and indication were not reported). No adverse effect was reported. Additional information has been requested.
Information has been received from an 86 year old female consumer with no known allergies or pertinent medical history who on 14-JUN-2007 was vaccinated in the left arm with a dose of Zostavax (Oka/Merck).   Concomitant therapy included metformin, "tapatril", hydrochlorothiazide (manufacturer unknown), ALEVE and "soricane".  On 18-AUG-2007 the patient developed shingles on the right side waist and side of breast.  Medical attention was sought.  There were no labs performed.  It was noted that the physician believed the patient had a mild case because she received the shot and she had no pain.  At the time of the report the patient had not recovered.  There was no product quality complaint involved. No further information was provided.  Additional information has been requested.
Information has been received from an office manager concerning a female patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot # not reported). On an unspecified date after receiving the vaccine the patient developed cellulitis and was hospitalized. The outcome of the patient's cellulitis was not reported. Follow up information has been received from a office manager concerning a 65 year old female with barrett's oesophagus, hypertension, osteoporosis, spinal stenosis, penicillin allergy, cephalosporin allergy, iodine allergy and a history of hysterectomy three weeks ago (in approximately 26-SEP-2009), tubal ligation and colonoscopy who on 13-AUG-2009 was vaccinated with a first dose of PNEUMOVAX 23 (lot # 662842/1296X) subcutaneously into left arm. Concomitant therapy included benazepril HCl, calcium (unspecified), vitamin D (unspecified) and timolol maleate (manufacturer unknown). On 14-AUG-2009 the patient came into the emergency room with a complain of fever, redness and swelling in the left arm after receiving PNEUMOVAX 23. The patient stated the tech who gave the injection, scrubbed one part of her arm with alcohol and then injected a long dirty needle into other side. The patient was having fevers of 100.4 degrees F. She stated that she was feeling okay otherwise, but the rate at which this cellulitis spread alarmed the patient. On 15-AUG-2009 the patient was admitted into a hospital after she was noted to have this significant cellulitis. There was concern for the development of a necrotizing fasciitis given the extent of this cellulitis at that time she was admitted; however, the patient responded quite rapidly to clindamycin and the second hospital day, it was much improved. On the same day on 15-AUG-2009 laboratory test revealed; white blood count high, red blood count low, hematocrit low, MCH high, RDW low, neutrophil count high, sodium low, bicarbonate low and no microorganisms in blood culture. On 16-AUG-2009 laboratory test revealed monocyte low. On 17-AUG-2009 the patient was discharged. At that time, the patient cellulitis was completely resolved. There was no visualized cellulitis. Cellulitis in the left arm and flank were completely gone. The patient's blood pressure was noted to be basically normal at that point. The patient had regular rate and rhythm, S1 and S2 normal, the patient was awake, alert and in no acute distress, lungs were clear to auscultation, abdomen was soft and no cyanosis in extremities. Primary care was scheduled in two to four weeks. Additional information is not expected.
Injection site pain, Fever, chills,  tiredness, injection site swelling, injection site redness, injection site warm/hot to touch. Tylenol and Motrin for fever. Contacting Dr today to see if I need to be seen for cellulitis.
Really sick; body aches; Fever; chills; sleepy; weak; feel bad/miserable; Faint; Nauseous; headache; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine; Lot number: EL3302) via an unspecified route of administration in the left arm on 01Mar2021 at 11:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included ulcerative colitis, appendix cancer, ileostomy, kidney transplant, MTHFR, cerebral meningitis and brain surgery; heart murmur and stage 5 renal failure (unknown cause). The patient had allergy to shrimp and narcotics. Concomitant medications included mycophenolate mofetil (CELLCEPT), loperamide hydrochloride (IMODIUM), levetiracetam (KEPPRA), pantoprazole (MANUFACTURER UNKNOWN) and tacrolimus (PROGRAF). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 03Mar2021, the patient started to feel bad- nauseous, headache, fatigue and faint. On 04Mar2021, the patient was really sick-nauseous, headache, fatigue, faint, body aches, fever, chills, sleepy and weak. On 05Mar2021, the patient had headache, chills, sleepy, miserable, weak and faint. On 06Mar2021, the patient had headache, fatigue, sleepy, a bit better, not so miserable, weak but still felt faint. On 07Mar2021, the patient had headache, fatigue, really miserable again, chills, sleepy and faint. On 08Mar2021, the patient had small fatigue and was a bit better. From 09Mar2021 to 12Mar2021, the patient was doing great with occasional nap, was gaining strength back and was not so faint. On 13Mar2021, the patient had bad fatigue, miserable, faint again. On 14Mar2021, the patient felt occasional faint, sleepy, fatigue and was gaining strength back. The adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient had not received any treatment for the reported events. The clinical outcome of the events was recovering.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: RMH (Medical History#5 verbatim updated to brain surgery and recoded to Brain operation NOS, Medical History#3 verbatim updated to Stage 5 Renal failure, and Medical History#7 verbatim updated to MTHFR), Suspect details (Start Date/Time and Stop Date/Time updated to 01-MAR-2021 11:00, Vaccine Facility Information added), Concomitant Medication (Cellcept coded via WHO), Event details (Description as reported for event Felt faint updated to faint, Event feel bad added and coded to feeling bad, Event Really sick added and coded to sickness).
57yo at first dose in 2019, second dose 08-mar-2022; 57yo at first dose in 2019, second dose 08-mar-2022; 57yo at first dose in 2019, second dose 08-mar-2022; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 57-year-old patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis.   Concomitant products included eculizumab (Soliris).   On 8th March 2022, the patient received the 2nd dose of Menveo. On 24th June 2019, the patient received the 1st dose of Menveo. On 24th June 2019, not applicable after receiving Menveo and unknown after receiving Menveo, the patient experienced inappropriate age at vaccine administration. On 8th March 2022, the patient experienced inappropriate age at vaccine administration and drug dose administration interval too short. On an unknown date, the outcome of the inappropriate age at vaccine administration, drug dose administration interval too short and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: The age at vaccination was unknown for the 2nd dose. The reporter stated that the patient was vaccinated with first dose of Menveo at 57 years of age, which led to inappropriate age at vaccine administration.  The patient was administered 2nd dose of Menveo earlier than the recommended interval and at inappropriate age not as per recommended package insert, which led to inappropriate age at vaccine administration and drug dose administration interval too short. The patient was taking medication Soliris that was why they were getting this at that age. The reporter consented to follow up.
C/o hives on day 15 after #2 JE vax. Hives began behind knees, inner thigh, progressed to top of feet and back area.Tx w/ Mymethadone for 7 days.
nstemi; Myocarditis; This is a spontaneous report from a contactable physician. A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown) via an unspecified route of administration on 26Apr2021, SINGLE for covid-19 immunization. The patient's medical history was not reported.  The patient had no known allergies. The patient's concomitant medications were not reported. The patient did not receive  any other vaccine within 4 weeks prior to the vaccine. On 27Apr2021, the patient reported to the hospital with complaints of chest pain with electrocardiogram (EKG) showing non-diagnostic diffuse ST elevations and elevated cardiac biomarkers. On 27Apr2021, the patient experienced non-ST-elevation myocardial infarction (NSTEMI) and myocarditis. The patient was hospitalized for one day. and the event required an emergency room/department or urgent care visit. The patient underwent lab tests and procedures which included blood test: negative on 02May2021, covid-19: negative on 02May2021, electrocardiogram: unknown showing non-diagnostic diffuse ST  elevations and elevated cardiac biomarkers, myocarditis: unknown. Cath report did not reveal coronary artery disease (CAD). Therapeutic measures were taken as a result of NSTEMI (acute myocardial infarction), myocarditis (myocarditis), chest pain (chest pain), EKG showing non-diagnostic diffuse ST elevations and elevated cardiac biomarkers. The outcome of non-ST-elevation myocardial infarction (NSTEMI), myocarditis, chest pain and electrocardiogram (EKG) showing non-diagnostic diffuse ST elevations and elevated cardiac biomarkers was recovered on an unknown date. It was also reported that since the vaccination, the patient was tested for COVID-19 on 02May2021 and was negative.   Information on lot number/batch number was requested.; Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case.  Based on currently known drug profile it is unlikely that events non-ST-elevation myocardial infarction (NSTEMI) and myocarditis are related to BNT162B2. This case will be re-evaluated upon receipt of additional information. 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 and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.
Severe pain in right arm; Severe pain in shoulder; This is a spontaneous report from a non-contactable consumer, the patient. A 64-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the arm left on 27Apr2021 at 17:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the arm left on 06Apr2021 20:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. On 02May2021, after moderate yard work during afternoon, at 23:00 the patient experienced severe pain in right arm and severe pain in shoulder. The patient reported that, the pain was worsening. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with unspecified pain killer and ice pad. The clinical outcome of the events severe pain in right arm and severe pain in shoulder was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Patient experienced bruising on the left arm and other parts of the body (abdomen and both legs).
booster; "messed up" stomach; she experienced a fever; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program (060820).  A 33 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 33 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "triple negative breast cancer" (ongoing); "intravenous chemotherapy" (unspecified if ongoing), notes: intravenous chemotherapy. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE, UNKNOWN MANUFACTURER), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; ABDOMINAL DISCOMFORT (non-serious), outcome "not recovered", described as ""messed up" stomach"; PYREXIA (non-serious), outcome "recovered", described as "she experienced a fever". The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report as received from the clinical research coordinator referring to a patient of unknown age and gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported. On unspecified date, the patient was vaccinated with an improperly stored dose of ROTATEQ lot number R002805 and expiration date 23-SEP-2019, or lot number R016790 and expiration date 20-APR-2020, for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of 8.2 degrees Celsius for 6 minutes. Previous temperature excursion of 11.5  degrees Celsius for 37 minutes There was no adverse effect reported. Sender's Comments: US-009507513-1903USA008125.
Narrative:  Patient received three doses of Pfizer COVID 19 Vaccine. The patient tested positive for COVID 19 on 20 Jan 2022. The patient presented to the ED with shortness of breath, cough, and wad admitted in another hospital for COVID pneumonia. The patient was treated with remdesivir and dexamethasone. The patient was discharged, but the patient was readmitted to the hospital on 6 February 2022 with cough and shortness of breath. The patient was admitted with COVID pneumonia and respiratory failure. The patient was treated with antibiotics. The patient was discharged 10 Feb 2022 in stable condition. Reported per EUA.
No adverse event; I gave a wrong bivalent vaccine to a child, they received a dose from a dark pink cap vial instead of a dose from a blue cap vial of the Moderna COVID19 vaccine bivalent; This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (I gave a wrong bivalent vaccine to a child, they received a dose from a dark pink cap vial instead of a dose from a blue cap vial of the Moderna COVID19 vaccine bivalent) and NO ADVERSE EVENT (No adverse event) in a 4-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Aug-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 21-Aug-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced INCORRECT DOSE ADMINISTERED (I gave a wrong bivalent vaccine to a child, they received a dose from a dark pink cap vial instead of a dose from a blue cap vial of the Moderna COVID19 vaccine bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (I gave a wrong bivalent vaccine to a child, they received a dose from a dark pink cap vial instead of a dose from a blue cap vial of the Moderna COVID19 vaccine bivalent) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (I gave a wrong bivalent vaccine to a child, they received a dose from a dark pink cap vial instead of a dose from a blue cap vial of the Moderna COVID19 vaccine bivalent).    No concomitant medication was reported. Patient was not previously vaccinated.  No treatment medication was reported.
*Chest Pain (Left Side) Swollen Lymph Node (Left Armpit) Shortness of breath Increased heart rate
Large welt on arm, redness, bruised, extremely painful on entire top of arm from elbow up to shoulder.
Joint pain and swelling noted at RIGHT knee and RIGHT ankle, states had muscle pain above RIGHT knee and at RIGHT foot. States at approx. 3pm client could not lift her RIGHT leg independently, had to manually maneuver.  Pain and limitations lasted about 36 hours from first noting symptoms to complete alleviation.  Client did not vist MD, but did keep in touch with them via phone.
PATIENT EXPERIENCED CHIILS, NAUSEA, FEVER, FLU LIKE SYMPTOMS.
no adverse event; the excursion occurred; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 21-SEP-2021, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # T040202, expiry date 11-SEP-2022) for prophylaxis.  The suspect vaccine was stored in a temperature of 26.1 degrees Celsius (C) for 2 hours and 23 minutes. There was no previous temperature excursion. The patient did not report any symptoms after administration. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T040202; expirationdate: 11-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
About 5 hours after receiving the vaccine my arm swelled up, turned red, was hot to the touch, very painful and itched. I took some advil with no relief.  The next day the pain radiated from my elbow up to my neck area.  As days progressed the pain continued and my arm was feeling weaker. My husband had the shot the year before and told me it was a rough one and the pain would go away.  Painin my arm, neck, shoulder and rear shoulder blade is a daily pain.  My arm has become weaker and my range of motion became less and less.  Sleeping on my left side is almost impossible. Raising my left arm outward away from my body has decreased by about 70%.  Daily life has been impacted.  I finally contacted my doctor when I re
UTI symptoms began about 2 days after vaccine. Called teledoc, received a 5-day course of Macrobid antibiotic
Initial case received from a pharmacist, who is also the patient's daughter, on 27 January 2014. A 57-year-old female patient, with no reported medical history or concomitant medications, received a first dose of FLUZONE (lot number U3727AA) intramuscularly on 30 November 2010. The same day as vaccination, at an unspecified time, she began experiencing difficulty breathing described as "could not get air", lip swelling, eye swelling, flushed face, and possibly a rash. She did not seek any medical attention, and the patient reported that the events had recovered on an unspecified day. Additional information has been requested. Documents held by sender: None.
This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 20-JUN-2016, the patient was vaccinated with an improperly stored PNEUMOVAX 23 10 PK, lot # L002310, expiration date 08-JUL-2016, at a dose of 0.5 ml, (route and anatomical location of administration were unspecified). The vaccine underwent two total temperature excursions, of 168 hours and 920 hours. The lowest recorded temperature in the first excursion (168 hours) was 32 Fahrenheit degrees (0 Celsius), and the lowest recorded temperature in the second excursion (920 hours) was 34 Fahrenheit degrees (1.111111111 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown ages and genders. On an unknown date, the patients were vaccinated with PNEUMOVAX 23, vaccine had been exposed to multiple excursions with highest temperature reaching 57F for total time of 206 hours and these vaccines' stability could not be supported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Pt c/o moderate-severe left shoulder pain, recommended otc pain meds, f/u with pcp if symptoms worsen or do not improve
This spontaneous report was received from a health care professional refers to unspecified patients of unknown demographics. Approximately in 2016 (also reported as "unspecified dates since 09-FEB-2016") the patients were vaccinated with improperly stored PROQUAD (Merck) (dosing regimen unspecified) (L044056/ exp. 02-MAY-2017; L032761/ exp. 24-FEB-2017; L042818/ exp. 26-APR-2017). This request was originally opened on 09-FEB-2016 to evaluate improperly stored vaccines. The healthcare worker called back to evaluate the same doses, which were previously exposed to temperatures outside of the recommended range, and had been administered to patients since this service request was opened. Healthcare worker reported that doses of the following, which were exposed to the following conditions, were administered to unspecified patients: temperature: -10.96C, Time frame: 15 hours, previous temperature excursion: -11.51C for 15 hours. It was not a call because of a data logger. No additional information was provided. This is one of the two reports from the same reporter. Additional information has been requested.