chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No Adverse event; Patient received Moderna Bivalent Booster 0.25mL dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received Moderna Bivalent Booster 0.25mL dose) and NO ADVERSE EVENT (No Adverse event) in a 57-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 13-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received Moderna Bivalent Booster 0.25mL dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received Moderna Bivalent Booster 0.25mL 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient received Moderna Bivalent Booster 0.25mL dose).    Concomitant medications details were not reported by the reporter.  Treatment details were not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 17-Oct-2022: Follow-up document contains updated batch number of suspect product.
Pt with history of multiple drug allergies including anaphylaxis to IV antibiotic of some kind.  Rec'd first dose of Pfizer vaccine at 1419. At 1425, C/O "throat feeling swollen" and noticeable generalized flush. No SOB or wheezing, able to maintain conversation with nurse. VS stable.  Notified EMS per adverse drug reaction chart. EMS arrived and transported patient to Hospital.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/10/2022 HYPONATREMIA R57.1 HYPOVOLEMIC SHOCK 3/4/2022 HYPONATREMIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/10/2022 CANCER METASTATIC TO LIVER R57.1 HYPOVOLEMIC SHOCK 3/4/2022 CANCER METASTATIC TO LIVER J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/10/2022 ADENOCARCINOMA METASTATIC TO LIVER R57.1 HYPOVOLEMIC SHOCK 3/4/2022 ADENOCARCINOMA METASTATIC TO LIVER J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/10/2022 ANEMIA R57.1 HYPOVOLEMIC SHOCK 3/4/2022 ANEMIA
Pt recvd vax & devel an abscess @ the inject site following vax w/Hep B vax; No further details were provided;
VACCINE BREAKTHROUGH INFECTION - Symptoms lasted for several days, required consultation with physicians and extra care at home, but did not necessitate in-person medical care.  (Prior to receiving vaccine, patient was high risk for severe disease due to neurological disease and history of complications with colds) 9/29/2022 (Day of positive test): Congestion, fatigue 9/29 - 10/2/2022: Vomiting increased from baseline, a bit dehydrated, a 100.2 fever, elevated heart rate (at one point it was 170s/180s but got better in time for us to avoid the ER), upper and lower congestion, slightly more labored than usual breathing, and coughing a fair amount, especially at night.  Parents kept in touch with child's pulmonologist for recommendations, and so he was able to be cared for at home.  He was mostly recovered by 10/2/22.  At-home care slightly more than typically needed for colds (history of emergent care needed during colds for respiratory issues, dehydration, etc).  At-home care included: monitoring of oxygen and heart rate via medical-grade Covidien pulse oximeter, increased chest physiotherapy, medical-grade nasal suction, substitute pedialyte for 1/2 of g-tube feeds, acetaminophen/ibuprofen, saline nasal spray, saline mist inhaler, mucinex at night, albuterol inhaler every 4 hours.
Her temperature it was 101.5; Crashing headache; This is a spontaneous report from a non-contactable consumer or other non hcp. A 13-years-old female patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number EW0217) via an unspecified route of administration on 25Jun2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received historical vaccine of first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number not reported) via unspecified route of administration on unspecified date as a dose 1 single for covid-19 immunisation. The patient experienced crashing headache on Jun2021, her temperature it was 101.5 on 26Jun2021. Therapeutic measures were taken as a result of crashing headache, her temperature it was 101.5. The patient underwent lab tests and procedures which included body temperature 101.5 on 26Jun2021. The outcome of the event headache was not recovered, and the outcome of the events pyrexia was unknown.  No follow-up attempts are possible. No further information is expected.
Dry mouth/throat, drinking 2-3 gallons of water a day. If he doesn't drink water then his calves hurt.
Pain in back still present; Swelling in the injection arm; Pain in injection arm subsided; Second dose not received; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Pain in back still present), VACCINATION SITE SWELLING (Swelling in the injection arm), VACCINATION SITE PAIN (Pain in injection arm subsided  ) and PRODUCT DOSE OMISSION ISSUE (Second dose not received) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (Pain in back still present), VACCINATION SITE SWELLING (Swelling in the injection arm), VACCINATION SITE PAIN (Pain in injection arm subsided  ) and PRODUCT DOSE OMISSION ISSUE (Second dose not received). At the time of the report, BACK PAIN (Pain in back still present) had not resolved and VACCINATION SITE SWELLING (Swelling in the injection arm), VACCINATION SITE PAIN (Pain in injection arm subsided  ) and PRODUCT DOSE OMISSION ISSUE (Second dose not received) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Reportedly, the patient did not receive the second dose at that time because she was still dealing with swelling in the injection arm and extreme back pain centering on the left lateral muscle.  In APR-2021, her doctor recommended that she was correct in not getting the second dose of the vaccine. The patient is not considering getting the second dose of the vaccine due to the Delta variant of the virus. Recently, the patient received a call from her doctor's office recommending that she do receive the second dose.   Treatment information was not provided.
Possible only diluent administered.; Inappropriate dose of vaccine administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation. On an unknown date, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced inappropriate preparation of medication (Verbatim: Possible only diluent administered.) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 17-MAY-2023 The reporter called to inform that there were vials of powder component of Rotarix left in that facility, which might have had indicated that it was probable that only the diluent was administered. The reporter did not consented to follow up. The patient received only diluent of Rotarix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
visit to ED with classic covid symptoms: diarrhea, fever shortness of breath, admitted for telemetry care-.
Acute Urticaria; terribly painful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2 , single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, manufacture unknown), for Covid-19 Immunization. The following information was reported: URTICARIA (hospitalization), outcome "unknown", described as "Acute Urticaria"; PAIN (hospitalization), outcome "unknown", described as "terribly painful". The patient was hospitalized for urticaria, pain (hospitalization duration: 5 day(s)).  Clinical course:To Whom it may concern, upon receiving my second dose of the Pfizer Covid-19 Vaccine I had a terrible allergic reaction that caused Acute Urticaria and I was Hospitalized for over 5 days. It was terribly painful and traumatizing. Now I'm faced with having to receive a booster dose to be sure I'm able to withstand contracting the new Covid strains that are out.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Shot was given on 9-11-17 by end of the day area where shot was given and above was swollen/hard/and hot. By the end of the day band-aid made an indent there was bruising delow a 4 x 3 inch patch. Pt. also had a sore arm on 9-14-17 (Thu) pt went to MD office on 9-15-17 less bruising but came into pharmacy.
Faintness 10 minutes after administration. No treatment. Patient very anxious about vaccines.
Patient stated her oncologist wanted her to receive the High dose due to receiving cancer treatment and had a note from her PCP in her chart.
Patient reported to friend she felt ill and had sudden cardiac arrest. ROSC after 1 hour. Found to have STEMI; trop >100 with trending over past 24 hours. Has likely significant anoxic injury, prognosis is grim. Because apparent MI occurred within the original Pfizer trial study period of 14 weeks, and also at our institution we have had 2 other cases of early age and unexpected fatal MI's s/p vaccine, decision made to report this case as potential vaccine adverse reaction.
First time occurrence of shingles on right shoulder, arm pit and scapula area; This is a spontaneous report from a contactable nurse (patient). A 47-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284), intramuscularly on right arm at 10:00 on 19Jan2021 (at 47 years old) at single dose for COVID-19 immunization. Medical history included hypertension (HTN). The patient's concomitant medications included: fingolimod hydrochloride (GILENYA), baclofen, mirabegron (MYRBETRIQ), bupropion hydrochloride (WELLBUTRIN), and hydroxyzine hydrochloride (HYDROXIN). The patient previously took his first dose of BNT162B2 (Lot number: EK5730) on Left Arm at 10:00 AM on 29Dec2020 for COVID-19 immunization, Ceftin and experienced drug allergies, erythromycin and experienced allergies. The patient experienced first time occurrence of shingles on right shoulder, arm pit and scapula area on 07Feb2021. The patient underwent lab tests and procedures which included Nasal Swab (PCR): negative on 05Feb2021. The patient received Valcyclovir as treatment. The outcome of event was not recovered.
Information has been received from a pharmacist concerning a "older" female patient who was vaccinated with a dose of Pneumovax 23. Subsequently the patient developed a round band of inflammation below the injection site. The area was warm to the touch. The vaccination was administered at the pharmacy. The pharmacist indicated she had never seen anything like it before. The patient's outcome was unknown. Additional information has been requested.
Death; Trouble in breathing; chills; sweating; his body was really cold; A spontaneous report was received from a consumer concerning a 79 years old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events death, trouble in breathing/dyspnoea, chills, sweating/hyperhidrosis and his body was really cold/hypothermia.  The patient's medical history included blood clotting, blood pressure and diabetes. The relevant concomitant medications reported were provided as medications for blood thinner, blood pressure medication and diabetes medication.  On 03 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA (Lot number: unknown) through intramuscular route of administration for prophylaxis of COVID-19 infection.  On 03 Mar 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA (Lot number: unknown) through unknown route of administration for prophylaxis of COVID-19 infection.  On 04 Mar 2021, after second dose patient experienced sweating, his body was really cold. His wife called ambulance and paramedics had quoted that these were usual symptoms of second shot and if they want, they can take him to hospital for monitoring. The patient doesn't want to go hospital and wanted to take rest in bed.  On 05 Mar 2021, at 2am, four hours after first ambulance call, his wife noticed that he was still sweating, had chills and also had trouble in breathing. She called the ambulance second time and while it arrived at home it was too late and he was already passed. All the events were provided as intervention/medically important.  No laboratory data was provided. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.  The events trouble in breathing, chills, sweating and body was really cold were not recovered.  The patient died on 05 Mar 2021, due to unknown cause of death but On 19 Mar 2021, his wife talked with primary care physician and he mentioned that vaccine is one of the contributing factors to his death and it is noted on his death certificate. Plans for autopsy was unknown.; Reporter's Comments: This is a case of sudden death in a 79-year-old fmale patient with a history of blood clotting, abnormal blood pressure and diabetes, who died 2 days after receiving second dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: unknown cause of death
COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11May2023 as dose 4 (booster), single (Lot number: AS7184B) at the age of 45 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" (18Aug2023) and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Aug2023) Negative; (19Aug2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included received Paxlovid from 12Aug2023 to 16Aug2023. Clinical courses: Covid rebound (19Aug2023) after paxlovid. Symptoms disappeared completely for 2 days with multiple negative tests, sore throat and congestion symptoms along with positive covid test came back following day. No known allergies.  No follow-up attempts are possible. No further information is expected.
Left side of face swollen from ear to chin, real puffy, no redness. Got better/resolved on 6/8 pm. Soreness at injection site.
Information has been received from a certified medical assistant concerning a 27 year old female who on 27-SEP-2005 was vaccinated with pneumococcal23v polysaccharide vaccine (lot 650648/0967P), 0.5 ml, one dose.  On 29-SEP-2005 the patient reported pain, swelling, redness and warmth at the injection site.  As of 03-OCT-2005 the patient was recovering from her experiences.  Additional information has been requested.
aspirating lungs due to Pneumonia; vaccination complication; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of PNEUMONIA ASPIRATION (aspirating lungs due to Pneumonia) and VACCINATION COMPLICATION (vaccination complication) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039H21A) for COVID-19 vaccination.     Medical history was not provided.  Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR), PREDNISONE and PENTOXIFYLLINE for an unknown indication.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PNEUMONIA ASPIRATION (aspirating lungs due to Pneumonia) (seriousness criteria hospitalization and medically significant) and VACCINATION COMPLICATION (vaccination complication) (seriousness criterion hospitalization). At the time of the report, PNEUMONIA ASPIRATION (aspirating lungs due to Pneumonia) and VACCINATION COMPLICATION (vaccination complication) outcome was unknown.            No known allergies were reported Concomitant product include "lymphatics". Treatment information was not  provided. Action taken with mRNA-1273 in response to the event was not applicable.  Very limited information regarding this event has been provided at this time.  Further information has been requested.   This case was linked to MOD-2021-138790 (Patient Link).; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Afib; Lightheaded/dizzy; nervous; Dehydrated; Problems with vision; Tachycardia; Problems concentrations; Fatigued/Tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (Afib) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 098K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    The patient's past medical history included No adverse event (No reported medical history).   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ATRIAL FIBRILLATION (Afib) (seriousness criterion medically significant), DIZZINESS (Lightheaded/dizzy), NERVOUSNESS (nervous), DEHYDRATION (Dehydrated), VISUAL IMPAIRMENT (Problems with vision), TACHYCARDIA (Tachycardia), DISTURBANCE IN ATTENTION (Problems concentrations) and FATIGUE (Fatigued/Tired). At the time of the report, ATRIAL FIBRILLATION (Afib), DIZZINESS (Lightheaded/dizzy), NERVOUSNESS (nervous), DEHYDRATION (Dehydrated), TACHYCARDIA (Tachycardia), DISTURBANCE IN ATTENTION (Problems concentrations) and FATIGUE (Fatigued/Tired) outcome was unknown and VISUAL IMPAIRMENT (Problems with vision) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments Treatment included metoprolol, digoxin and diltiazem. No concomitant medication was provided.  The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, The patient's advance age may remain a risk factor for the event Atrial fibrillation. Further information has been requested.
It gave me bone pain all over my body. Fever. Pain, Swelling, warm area to the touch in the puncture area. Weakness. Stop eating food. Pain when breathing Edema in upper extremities. Headache. Cough which altered when eating food.
i feel like im gonna die; shot in the arm is really painful; great pain in my arm and muscles are cramping all over; running a temp of 101.6; Nauseous; have throw up; muscles are cramping all over; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (i feel like im gonna die), VACCINATION SITE PAIN (shot in the arm is really painful), MYALGIA (great pain in my arm and muscles are cramping all over), PYREXIA (running a temp of 101.6) and NAUSEA (Nauseous) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   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 FEELING ABNORMAL (i feel like im gonna die), VACCINATION SITE PAIN (shot in the arm is really painful), MYALGIA (great pain in my arm and muscles are cramping all over), PYREXIA (running a temp of 101.6), NAUSEA (Nauseous), VOMITING (have throw up) and MUSCLE SPASMS (muscles are cramping all over). At the time of the report, FEELING ABNORMAL (i feel like im gonna die), VACCINATION SITE PAIN (shot in the arm is really painful), MYALGIA (great pain in my arm and muscles are cramping all over), PYREXIA (running a temp of 101.6), NAUSEA (Nauseous), VOMITING (have throw up) and MUSCLE SPASMS (muscles are cramping all over) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.6. (Inconclusive) 101.6..         no treatment information was provided no concomitant medication were reported
High blood pressure, nervousness, insomnia, general body pain, lower back problems, thyroid problems, hearing problems.
Fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (The patient also mentions that when he received dose 1 of Shingrix he had a fever but it only lasted 2 days.).   On 11th November 2021, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, 24 hrs after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient for himself. The patient received second dose of shingrix vaccine and 24 hours later had fever. The patient had fever ever since the vaccine.(17 days). The patient talked to his health care professional who changed some of his medications. The reporter consented for follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR246108:same reporter