chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a licensed practical nurse and a healthcare worker referring to unspecified patients of unknown age and gender. In June 2015 (also reported as since 15-JUN-2015), the patients were vaccinated with doses of GARDASIL (lot # K006960, expiration date: 19-FEB-2017, dose and route were unknown) which were exposed to temperatures outside of the recommended range. No adverse experience was reported. This is one of several reports received from the same reporter. Additional information has been requested.
afebrile, focal, sz 5 hrs p/1st vax w/transient todd's paralysis 6th cranial nerve;
Extreme swelling at injection site, site was hard, red and swollen for 6-7 days. Child had fever of 101 for 3 days, and was covered in hives. Injection site bruised significantly, and although fever subsided for a few days, hives remained, and became much worse on day 10. Injection site was the first place to turn red and become covered in hives...about a four inch tall band around her arm, then hives spread to her trunk and face. fever returned, and we opted to go to the E.R. It was confirmed that it was allergic reaction, but Doctor would not confirm it was the vaccines, even though the only constant symptom was redness and hives at vaccine site. Child was given benadryl which only helped in the sense that she was able to sleep, but here on day 11, she is still feverish and covered in hives. Pain at injection site causes tears when I touch it, and we will be visiting pediatrician this week if symptoms continue.
Patient arrived from outside hospital where he was in ER for afib with RVR. Upon arrival from transfer he immediately appeared to be very hypoxic with O2 saturation in the 50s. Patient was still conscious but skin was turning blue. Rapid response was called and rapid response team quickly arrived. Patient was on 15 L of oxygen, but could not get good reading for saturation. ABG was drawn and showed PO2 of 21 with PH of 7.13 and LA of 12.0. Patient became more unresponsive. Patient's blood pressure began to drop and code blue was called as pulse was lost and patient appeared to be in PEA arrest. Patient was coded for ~ 40 minutes without success.
Since the vaccine I have been having right sided hearing loss. Two days after my first dose I felt like I was underwater when talking to people, as their speech was distorted. I also felt pressure in my ear, as if it was filled with fluid, and was unable to "pop" my ears. I was evaluated by an ENT and there was no infection or fluid in my ear. It started to get better a little.  After my second dose, the symptoms worsen. My hearing loss was back worse than the original time and this time I had tinnitus constantly. I also had chills, fevers, myalgia, back pain, and headaches.
Daily headaches of varying severity without any accompanying  neurological symptoms since the day after vaccination. Headaches described by patient as " worse than usual".
shortness of breath which is on and off/shortness of breath can be from anxiety from schooling; heart murmur; 16 year old patient received 1st dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old patient received 1st dose of Moderna COVID-19 vaccine), DYSPNOEA (shortness of breath which is on and off/shortness of breath can be from anxiety from schooling) and CARDIAC MURMUR (heart murmur) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     The patient's past medical history included Anxiety (anxiety from schooling). Concomitant products included DESOGESTREL, ETHINYLESTRADIOL (APRI) for Birth control pill, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for Supplementation therapy.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old patient received 1st dose of Moderna COVID-19 vaccine). On 17-Apr-2021, the patient experienced CARDIAC MURMUR (heart murmur). On an unknown date, the patient experienced DYSPNOEA (shortness of breath which is on and off/shortness of breath can be from anxiety from schooling). On 07-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old patient received 1st dose of Moderna COVID-19 vaccine) had resolved. At the time of the report, DYSPNOEA (shortness of breath which is on and off/shortness of breath can be from anxiety from schooling) and CARDIAC MURMUR (heart murmur) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Apr-2021, Echocardiogram: abnormal (abnormal) 2 different readings for patient's echocardiogram. On 17-Apr-2021, Physical examination: abnormal (abnormal) heart murmur at physical checkup.     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.
This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 28-AUG-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L003855 exp date 05-FEB-2017) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
Admit Date: 10/20/22   Discharge Date: 10/27/22   Discharge Condition: Stable    Discharge Diagnosis:   o Hyperosmolar hyperglycemic state (HHS) (CMS/HCC) o Type 2 diabetes mellitus (CMS/HCC) o Weakness of right foot o Abnormal EKG o Sinusitis o Hyperkalemia o AKI (acute kidney injury) (CMS/HCC) o Normocytic anemia o Metabolic acidosis with normal anion gap and bicarbonate losses o Hypertension o HLD (hyperlipidemia) o Mood disorder (CMS/HCC) o Seizure disorder (CMS/HCC) o GERD (gastroesophageal reflux disease) # COVID 19 infection
Diffuse pain throughout the body; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29May2022 at 17:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 53 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN oral. Vaccination history included: Covid-19 vaccine (DOSE: 3, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE: 2, MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE: 1, MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: PAIN (non-serious) with onset 30May2022, outcome "recovered", described as "Diffuse pain throughout the body". Therapeutic measures were not taken as a result of pain.  Additional information: Facility type vaccine was Pharmacy or Drug Store. The patient had no other vaccine in four weeks. Other medications in two weeks included Gabapentin. The patient had no Covid prior vaccination. The patient was not Covid tested post vaccination. Known allergies are Unknown.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a physician via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 27-FEB-2016, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 and lot number L014876 with expiration date of 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 27F (-2.777777778 Celsius) for 1764 hours. The vaccine status was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Patient reports having an itchy rash since date of vaccination. She has visited the doctor and emergency room with no relief.  She reports feeling weak and tired, as well as having raw rash from the itching.
Noticed lump on base of the right side of my neck in 4/15/21 around 3 in the afternoon. It was sore when much pressure was applied, but nothing else.  Went to doctor the next week. Next vaccine was on 4/27/21 and that night the lump was extremely sore and enlarged. Went for an ultrasound the following day.  Pain began to lessen by 4/30/21 but I started  Bactrim 5/2/21 to keep any potential infection at bay.
expired dose of Engerix-B administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) for prophylaxis.   On 14th December 2021, the patient received Engerix B. On 14th December 2021, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were reported as follows: The age at vaccination was not reported. The medical assistant reported that on the day of reporting, patient received dose of Engerix-B that was already got expired, which led to expired vaccine used. The Health care professional (HCP) did not had any information on adverse events details.  The Health care professional gave consent for safety team to follow up. The reporter consented to follow up.
Heartbeat started beating fast; Feeling weird; Pressure on the right side of her head; Blood pressure went up to 157; Headache on the right side of her head; Dizzy; Chills; Nauseous; Dry mouth; Left ear was hurting; Felt a lot of pressure; Felt groggy; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (Dry mouth), EAR PAIN (Left ear was hurting), EAR DISCOMFORT (Felt a lot of pressure), SOMNOLENCE (Felt groggy) and HEART RATE INCREASED (Heartbeat started beating fast) in a 26-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.     The patient's past medical history included No adverse event (No recorded medical history).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced DRY MOUTH (Dry mouth), EAR PAIN (Left ear was hurting), EAR DISCOMFORT (Felt a lot of pressure), SOMNOLENCE (Felt groggy), DIZZINESS (Dizzy), CHILLS (Chills) and NAUSEA (Nauseous). On 06-Jan-2021, the patient experienced HEART RATE INCREASED (Heartbeat started beating fast), FEELING ABNORMAL (Feeling weird), HEAD DISCOMFORT (Pressure on the right side of her head), BLOOD PRESSURE INCREASED (Blood pressure went up to 157) and HEADACHE (Headache on the right side of her head). On 06-Jan-2021, HEART RATE INCREASED (Heartbeat started beating fast) and BLOOD PRESSURE INCREASED (Blood pressure went up to 157) had resolved. At the time of the report, DRY MOUTH (Dry mouth), EAR PAIN (Left ear was hurting), EAR DISCOMFORT (Felt a lot of pressure), SOMNOLENCE (Felt groggy), FEELING ABNORMAL (Feeling weird), DIZZINESS (Dizzy), CHILLS (Chills) and NAUSEA (Nauseous) outcome was unknown and HEAD DISCOMFORT (Pressure on the right side of her head) and HEADACHE (Headache on the right side of her head) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2021, Blood pressure measurement: 157 (Inconclusive) Blood pressure was 157. On 06-Jan-2021, Heart rate: 92-97 (Inconclusive) HEART BEAT WAS BETWEEN 92-97.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       TNo concomitant medications were provided. reatment ADVIL
Expired dose of Pediarix was administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa-HBV-IPV (Pediarix) (batch number 2AJ32, expiry date 2nd September 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th October 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 25th October 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was 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: 27-Oct-2022 Reporter's comment: The pharmacy technician reported via chat that an expired dose of Pediarix was administered. The reporter asked that could you check the lot and saw that and was the correct expiration date. The national drug code (NDC) was 58160-0811-52. The reporter did not had that information. It was given at a remote sites of there. The reporter asked that could you email this information to him/her. No other information was known. The reporter did not consent to follow-up. Additional supportive information: The patient received an expired dose of Pediarix, which led to expired vaccine used.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Aug2021 at 07:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 53 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Known allergies: No. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication: Treatment of COVID-19; Negattive; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medications in two weeks: Unknown. The patient took Paxlovid from 20Jul2022 to 24Jul2022 for treatment of Covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Covid-19 and drug ineffective.
Swollen Lymph Nodes; LYMPH NODE PAIN; This spontaneous case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (LYMPH NODE PAIN) and LYMPHADENOPATHY (Swollen Lymph Nodes) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced LYMPH NODE PAIN (LYMPH NODE PAIN). On 20-Feb-2021, the patient experienced LYMPHADENOPATHY (Swollen Lymph Nodes). At the time of the report, LYMPH NODE PAIN (LYMPH NODE PAIN) and LYMPHADENOPATHY (Swollen Lymph Nodes) outcome was unknown.            Treatment and concomitant medications were not provided by reporter.
Patient came back with rash on hands after 1/2 hr. and complain about having nausea after 1 & 1/2 hr. (90 minutes).
Initial report was received from a healthcare professional on 20 August 2013. A 73-year-old female patient, with a history of arthritis, received an injection of ADACEL (lot number, route and site unknown) on 13 August 2013. One day later on 14 August 2013, the patient had a flare up of arthritis in her knee. The patient received a cortisone injection in the knee one week prior to receiving ADACEL. The patient is following up with her orthopedic physician. The patient had no known allergies (NKA). Outcome was reported as unknown. Documents held by sender: None.
This is a literature case, initially received on 19-Feb-2019, concerning a 43-year-old, adult female patient. The study describes the reports of anaphylaxis after vaccination reported to the Vaccine Adverse Event Reporting System (VAERS) during 1990-2016. A descriptive analysis, including history of hypersensitivity (anaphylaxis, respiratory allergies, and drug allergies) and vaccines given were performed. The patient's historical condition included depression and current condition included: hypertension. Patient did not have hypersensitivities. On an unspecified date, the patient was administered INN Flu Vaccine Seasonal (influenza vaccine, influenza virus vaccine polyvalent, anatomical location, dose, route of administration, batch number, manufacturer, trade name and expiry date: not reported) for an unknown indication. The following morning, after vaccination, patient was found dead. On autopsy, the body was noted to have patches of urticaria and airway swelling. The laboratory tests revealed an increased serum tryptase level. The documented cause of death was anaphylactic reaction (causality: related). The reporter assessed the case as serious (death). The author concluded that anaphylaxis of severe or life-threatening severity was very uncommon but could occur even among the persons without hypersensitivity. Most persons recovered fully with treatment, but serious complications, including possibility of death is a rare event. This case is cross-linked to the original case: 201902085 due to the same reporter.; Reporter's Comments: A 43-year-old, female patient with medical history (depression and hypertension) was found dead, 1 day after administration of INN Flu Vaccine. The autopsy reported patches of urticaria, airway swelling and the cause of death as anaphylactic reaction. The case meets level 1 of Brighton Collaboration criteria of diagnostic certainty for anaphylactic reaction. Considering the plausible temporal relationship between vaccination and reported fatal event (anaphylactic reaction) and lack of any underlying conditions or alternative more plausible causes, the company assessed the events as possibly related to suspect vaccine. The company assessed the event anaphylactic reaction as serious (medically significant).; Reported Cause(s) of Death: Anaphylactic reaction.
Reports immediately after IM injection of second dose of COVID vaccine, developed shooting pain into left arm/left side of collar bone.  Reports she woke up this morning - noticed left supraclavical lymph node swelling and tenderness and "tingling like pins and needles" from knees extending to feet bilaterally.  Reports onset of symptoms 09/30/2021 at 0530 am  treatment: follow up with PCP or seek medical attention right away (ER or 911) should symptoms worsen, weakness/numbness or worsening tingling to bilateral lower extremity, shortness of breath, chest pain, or change in neurological status.   will follow up with team member health care clinic in 5-7 days or sooner as needed
Today Is my 3rd day since I have taken the covid vaccine moderna, and im still experiencing pain on my arm, nauces. Chills, fever, muscle pain, joint pain, swollen glands, swollen lymph nodes, sour taste in my mouth, shortness of breath. Please tell me if I should got get medical care? I'm not pregnant
A sore arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (A sore arm at injection site) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included APIXABAN (ELIQUIS), SOTALOL, PARACETAMOL (TYLENOL), ALBUTEROL [SALBUTAMOL], EMPAGLIFLOZIN (JARDIANCE), FINASTERIDE (PROSCAR), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), FUROSEMIDE (LASIX [FUROSEMIDE]), GABAPENTIN, MAGNESIUM OXIDE, METFORMIN, MONTELUKAST SODIUM (SINGULAIR MINI), TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]), VITAMIN B6 and VITAMIN B12 [VITAMIN B12 NOS] for an unknown indication.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE PAIN (A sore arm at injection site). At the time of the report, VACCINATION SITE PAIN (A sore arm at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2020, SARS-CoV-2 test: negative (Negative) negative. On 18-Jan-2021, SARS-CoV-2 test: negative (Negative) negative test for his CoV-2 antibodies Nucleocapsid Protein IgG Antibody Test. On 22-Feb-2021, SARS-CoV-2 test: negative (Negative) negative. On 21-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.
Patient developed left breast cancer in Feb2022. Feels this is r/t the COVID injections.; Patient developed left breast cancer in Feb2022. Feels this is r/t the COVID injections.; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Aug2021 as dose 2, single (Lot number: FC3182) at the age of 60 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, single, Batch/Lot No: FB8448, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 10Aug2021, when the patient was 60-year-old, for COVID-19 Immunization. The following information was reported: BREAST CANCER FEMALE (medically significant), CONDITION AGGRAVATED (medically significant) all with onset 15Feb2022, outcome "recovering" and all described as "Patient developed left breast cancer in Feb2022. Feels this is r/t the COVID injections.". The event "patient developed left breast cancer in feb2022. feels this is r/t the covid injections." required physician office visit. Therapeutic measures were taken as a result of breast cancer female, condition aggravated.  Clinical course: Patient developed left breast cancer in Feb2022. Feels this is r/t the COVID injections. Patient had surgery for breast cancer as treatment. Patient did not received any other vaccines in four weeks. It is unknown that the patient had COVID prior vaccination and COVID tested post vaccination. Patient had no known allergies.    No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the event breast cancer female, condition aggravated and the suspect drug BNT162B2 cannot be excluded.  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 regulatory authorities, Ethics Committees, and Investigators, as appropriate