chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Blood disorder NOS (Patient reported he was in hospital in April 2021 due to blood infection) in April 2021. Concurrent medical conditions included Acute leukemia. Concomitant products included gilteritinib from 14-Apr-2021 to an unknown date for Acute myeloblastic leukemia. On 26-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Aug-2021, the patient experienced CHILLS (Chills). In August 2021, CHILLS (Chills) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Blood test: abnormal (abnormal) Lab numbers are up and down- No concern. In November 2021, Weight increased: 230 (High) weight gain from 205 to 230 pounds. Patient reported antibiotic medication as treatment for cough and pneumonia. Patient reported that he got chills, eats too much, gained weight and his lab numbers were up and down, patient reported that he used blankets for chills and was eating less for gained weight. Patient was enrolled in local sponsored patient support program- Patient Assist Program. Patient was taking Xospata 80 mg once daily tablet for acute myeloblastic leukemia with lot no 1787120 with expiry date of 31 Mar 2024 and therapy start date was reported as 14 April 2021.
Onset of tinnitus continuous to the present time. Painful injection sites in arms. Continued to the present time and slowly improving, but not resolved
I was barely able to get to the bathroom from the bedroom---a trip no more than 10 feet. It felt like I had no control over my motor functions.; I was barely able to get to the bathroom from the bedroom---a trip no more than 10 feet. It felt like I had no control over my motor functions.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 16Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "CRPS" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 IMMUNISATION. The following information was reported: MOVEMENT DISORDER (non-serious), MOTOR DYSFUNCTION (non-serious) all with onset 17Apr2021, outcome "unknown" and all described as "I was barely able to get to the bathroom from the bedroom---a trip no more than 10 feet. It felt like I had no control over my motor functions."  Additional information: Patient recently had second shot of vaccine for the COVID-19 pandemic. I had been told that the second shot would/could be a real issue with side-effects. Well, I am here to tell you that people who already suffer from a condition called Complex regional pain syndrome (CRPS) and any related ailment, they should really be warry of these side-effects. Patient had taken the shot on Friday. On Saturday patient was barely able to get to the bathroom from the bedroom--a trip no more than 10 feet. It felt like had no control over motor functions.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On June 19, 2021 I woke up with a sudden Single Sided Hearing Loss (SSHL) in my left hear.  I awoke to a loud tone in the left ear for approximately 5 minutes followed by profound deafness.  I was treated in the Hospital Urgent Care that day.  I did not have any ear infections, water in the ear, eardrum damage, earwax, or other identifiable cause for my hearing loss.  I was prescribed prednisone orally for 15 days.  On June 21, 2021 I was examined by an Audiologist at the ENT Clinic.  They confirmed the profound hearing loss in the left ear with a greater than 100 db hearing loss in all frequencies in that ear.  On June 25, 2021 I was examined by my regular Audiologist at the Medical Center.  She again confirmed a profound hearing loss with more than 90 db loss in all frequencies in the left ear.  She has ordered a hearing aid.  I was referred to the Ear Clinic.  I was examined there by a Nurse Practitioner who found no visible reason for my hearing loss.  I have received three corticosteroid shots in my ear.  I have been referred to be evaluated for Minier's disease.
Initial report received from a healthcare professional on 14 OCTOBER 2014. A 55-year-old female patient, whose medical history was, reported as shellfish none and concomitant medication were not reported, had received a dose of FLUZONE QIV (batch number, cycle in series and site of vaccination not reported) on 07-OCT-2014. On 17-OCT-2014, patient experienced a very significant reaction to a flu shot 15 years ago/she had a very significant reaction to testing for allergy with the FLUZONE QIV and itching. Illness at the time of vaccination was reported as none. Corrective treatment was not reported and laboratory investigations were reported as none. At the time of this report, the outcome of the event was reported as unknown. Documents held by sender: none.
Right deltoid muscle sore, especially when moving arm. Soreness has continued since vaccination in November.
cough; sore right injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough) and VACCINATION SITE PAIN (sore right injection site arm) in a 20-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history of patient was reported by the reporter.  Concomitant products included HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE HCL), CETIRIZINE, FENOFIBRATE, ARIPIPRAZOLE (ABILIFY) and MONTELUKAST for an unknown indication.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COUGH (cough) and VACCINATION SITE PAIN (sore right injection site arm). At the time of the report, COUGH (cough) and VACCINATION SITE PAIN (sore right injection site arm) outcome was unknown.            No treatment drugs were reported .   This case was linked to MOD-2021-335227 (Patient Link).
*Administration error: not previously vaccinated 5 year old should have received 1 dose of 0.25ml of Dark Blue Cap, Gray Border label Moderna vaccine, Instead received 0.05ml of Dark Pink cap yellow box label Moderna. Patient was administered dose at approximately 11am and error was discovered at approximately 2:45pm same day of administration (8/24/23). No adverse side effects were reported up until 4:30pm (8/24/23)
within 12 hours had a reaction to include significant shakes and chills. After a period of respite patient developed chest pains, was admitted to hospital on 14FEB, and diagnosed as having had a Type 2 heart attack.
anaphylaxis described as severe reactions; Feeling poorly/flat out; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 20210356466(5) ), 20210929143.  A 54 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2 (booster), single for covid-19 immunisation; janssen covid-19 vaccine (JANSSEN COVID-19 VACCINE), administration date 27Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cancer" (ongoing), notes: she had a cancer, Cancer (Cancer) (Unknown) (Continuing: Yes); "Vaccine Sensitivity" (ongoing), notes: Vaccine Sensitivity (Hypersensitivity) (Unknown) (Continuing: Yes). The patient's concomitant medications were not reported.  The following information was reported: ANAPHYLACTIC REACTION (medically significant) with onset 27Mar2021, outcome "not recovered", described as "anaphylaxis described as severe reactions"; FEELING ABNORMAL (non-serious) with onset 27Mar2021, outcome "recovering", described as "Feeling poorly/flat out". The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: positive.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event anaphylactic reactions cannot be totally excluded.
PARTIAL DOSE ADMINISTERED; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced partial dose administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of partial dose administered was not reported. This report was non-serious.
sore arm; This is a spontaneous report from a contactable consumer (patient). A 57-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN 6206, expiration date not provided), 1st dose via an unspecified route of administration, administered in arm left on 05Mar2021 15:00 at age of 57 years old as a single dose for COVID-19 immunisation.  Medical history included Hashimoto's Thyroiditis, migraine. Concomitant medications included levothyroxine sodium (SYNTHROID); liothyronine sodium (CYTOMEL); ethinylestradiol, norethisterone acetate (FEMHRT); meloxicam taken for Knee injury; magnesium. The patient previously took amoxycillin, celebrex, clindamycin and known allergies. The patient experienced sore arm on an unspecified date. After first dose, just a sore arm but patient was taking meloxicam for a knee injury and wondered if the anti-inflammatory tempered the reaction. The patient underwent lab tests and procedures which included polymerase chain reaction (PCR): negative (nasal swab) on 15May2021.  The outcome of the event was resolving. The patient was not pregnancy at time of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The report was reported as non-serious by reporter.
woke up about 3am on March  5 with my whole left side hurting me  the vaccine site was swollen and red
A red, warm area the size of my palm on the front of my upper arm 3-1/2 inches below the injection site.  It is tender to the touch.  It is    painful,  only when I touch the area.   This was first noticed the day after the injection.  It is still present and this is the evening of day two (3/29/21)
Day of shot, extreme fatigue along with slight additional aches, headache as usual. Lemon-sized lymph node outside armpit of shot. On 5/1 noticed a bruise on side of breast and chills. No fever. Hopefully all will be gone soon otherwise will see physician.
UNDER THE WEATHER; LEGS AND FEET FALLING ASLEEP; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 2021, the subject experienced legs and feet falling asleep. On MAR-2021, the subject experienced under the weather. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from under the weather, and the outcome of legs and feet falling asleep was not reported. This report was non-serious.
A report has been received from a Physician concerning a patient, Male subject, who had been receiving FLUMIST QUARDIVALENT (intranasal). FLUMIST QUARDIVALENT started on 14-Jan-2014. The patient received expired FLUMIST QUARDIVALENT. The outcome of the event of received expired FLUMIST QUARDIVALENT is unknown. The report was considered to be non-serious.
patient woke up with hives that itched.  Patient was going home to take benadryl and hydrocortisone cream
Felt sick to stomach, head warm, face flushed, sweaty, lying on mat. Taken to school nurse's office. Able to ambulate ok.
After immunizations given, patient felt immediate malaise, nausea. Blurred vision, polydipsia next day and persisted thereafter with increasing fatigue.
Vaccinated at school complained of Dizziness and nausea started about 3/4 hour after shot durring basket ball practice and lasted about 24 hours. Never passed out or vometed and did eat meals. Nothing else
patient received dose of Moderna vaccine post excursion; patient received dose of Moderna vaccine post excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion), POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion), POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion), POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion) and POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion).    This case contains information for the 10th of 19 patients reported by the reporter. No concomitant medication were reported. No treatment medication were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-706941 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706941:pt 1 of 19
wasn't feeling good; he feels like he's going to fall out or pass out; he feels like he's going to fall out or pass out; walking like he is intoxicated with a wobble; sluggish all the time; heart rate has been elevated; nauseous; cold chills; severe headache; This is a spontaneous report from a contactable consumer (patient). The 33-years-old male patient received bnt162b2, dose 2 via an unspecified route of administration, administered in Arm Left on 03Apr2021 14:00 (Lot Number: ER8727) as single dose for covid-19 immunization at the age of 33 years old. Medical history included asthma, scoliosis, his scoliosis has never caused him to walk like this before. The report was not related to a study or programme. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Concomitant medication(s) included marijuana. No additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient previously received bnt162b2, dose 1via an unspecified route of administration, on 13Mar2021 (Lot Number: EP7534) in right arm as single dose for covid-19 immunization at the age of 33 years old. The patient experienced he feels like he's going to fall out or pass out, walking like he is intoxicated with a wobble, sluggish all the time, heart rate has been elevated in May2021, nauseous, cold chills and severe headache on 04Apr2021, wasn't feeling good on an unspecified date. Reported as: The caller received both doses of the vaccine. He had the second dose of the vaccine on 03Apr2021 and about a month after the second dose (in the beginning of May2021) he noticed that he is walking like he is intoxicated with a wobble, he is sluggish all the time, and he cannot control pretty much how he feels sometimes. Sometimes feels like he is going to fall or pass out and his heart rate has been elevated. That all started about a month ago, which was a month after the vaccine and it is progressively getting worse. His boss is asking him if he has been drinking. He is not intoxicated. He reports the day after he received the second Covid 19 vaccine on 04Apr2021, he went to the emergency room because he wasn't feeling good. When asked to elaborate he says he felt nauseous, he had cold chills, and a severe headache. He was discharged from the emergency room. He had some blood work done and a Covid 19 virus test. His bloodwork was fine and his Covid 19 virus test was negative. The AEs Nauseous, cold chills, severe headache, Feeling unwell required a visit to Emergency Room. The outcome of the events Feeling abnormal, Feeling unwell, Headache, Chills, Nauseous was unknown and not recovered for the rest events.
Fever around 101 lasted for 12 hours, lethargy and body aches lasted for 24-48 hours. Treated with Acetaminophen and Ibuprofen. All symptoms resolved within 48 hours
large painful swelling in left armpit appeared 3 days after vaccination.  lump had receded about 90% after 3 days.  there is still a small residual lump 13 days after vaccination.
pt recv vax 1NOV96 pt was found to be pregnant (LMP 25OCT96);pt believed that pt conceived on approx 8OCT96;pt had a spontaneous abortion @ 9.5 weeks;No further details are expected;
This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion), WRONG PRODUCT ADMINISTERED (Received the 611-year-old vaccine instead of the 12 plus vaccine./received the Monovalent Moderna COVID-19 vaccine instead of the Bivalent Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion), WRONG PRODUCT ADMINISTERED (Received the 611-year-old vaccine instead of the 12 plus vaccine./received the Monovalent Moderna COVID-19 vaccine instead of the Bivalent Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion), WRONG PRODUCT ADMINISTERED (Received the 611-year-old vaccine instead of the 12 plus vaccine./received the Monovalent Moderna COVID-19 vaccine instead of the Bivalent Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.         No concomitant product use was reported.  The patient received Booster dose.  It was reported by the reporter that the facility had a temperature excursion in the freezer. They had an inspection and saw that their DDL was not recording the temperatures. At the time of excursion, the products were in frozen storage as unbroken cartons. However, the excursion duration and temperature were unknown.  Both vial sizes of 2.5ml and 5.5ml were affected.  At the time of report the product was returned to the freezer.  It was further reported that the patient was administered the 611-year-old Moderna COVID-19 vaccine instead of the 12 plus Moderna COVID-19 vaccine.  No treatment information was provided.
This spontaneous report was received from a Registered Nurse referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On unknown dates, the nurse reported that the patients had received improperly stored vaccine of GARDASIL 9 Lot #M034195 and expiration date: 29-APR-2019 (dose and route of administration were not reported) for prophylaxis. It was reported a temperature between 0° centigrade to 2° centigrade during a time frame of 39 minutes. There was no previous temperature excursions and the call was because of a data logger. No symptoms were reported. There was no product quality complaint involved. This was one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA006249: US-009507513-1702USA010188:
Started running fever oof 102 about 48 hours after vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 23-month-old male patient received BNT162b2 (BNT162B2), on 23Jun2022 as dose 1, single (Lot number: FT9142) at the age of 23 months for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 25Jun2022, outcome "not recovered", described as "Started running fever oof 102 about 48 hours after vaccine". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.
This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a 50-year-old male subject who was vaccinated with Engerix B, Havrix A for prophylaxis. Previous and/or concurrent vaccination included influenza virus vaccine, manufacturer unspecified; right arm given on 17 November 2005. On 26 April 2005, 2 June 2005 and 17 November 2005 the subject received 1st dose, 2nd dose and 3rd dose of Engerix B (unknown, left arm). On an unspecified date the subject received 1st dose of Havrix (unknown). On 8 November 2007, at an unspecified time after vaccination with Havrix, 2 years after vaccination with Engerix B, the subject experienced not responding to therapy, hepatitis b antibody negative and hepatitis a antibody negative. Titers for hepatitis B antibodies were less than 5m1U per ml. Titers for hepatitis A were not reported. The subject required medical attention in the physician's office. The subject is getting ready to travel and wanted to make sure they were protected against hepatitis A and hepatitis B. At the time of reporting the events were unresolved. The healthcare professional considered negative Hepatitis B antibody titers was probably related to vaccination with Engerix B. Causality was unknown for negative hepatitis A antibody titers.
Fainted, recovered in 30 seconds. Vomited x 1. Observed & recovered. No residual effects.