chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash; Minor swelling; Itching; Pain at the injection site; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK9231), via an unspecified route of administration from 24Dec2020 at single dose for covid-19 immunization. None medical history nor concomitant medications. It was reported that yesterday (03Jan2021) there was a rash with very minor swelling, itching, pain at the injection site. The outcome of events was unknown.
WITHIN 2 HOURS OF PNEUMONIA VACCINATION PATIENTS ARM BECAME PAINFUL. IT CONTINUED TO WORSEN BECOMING MORE PAINFUL AND SWOLLEN. PT RETURNED TO CLINIC FOR SYMPTOMS 3 DAYS POST INJECTION. PREDNISONE 40 MG DAILY FOR 2 DAYS GIVEN. IBUPROFEN 200 MG 2 PILLS FOUR TIMES DAILY FOR 2 DAYS. PT SEEN AGAIN 6 DAYS POST INJECTION AND STATED HIS ARM WAS "FEELING FINE".
He got a combo including Dtap/polio. Not sure what else. I did not receive paperwork for it. Fever of 103 taken under the arm until following morning. Fever in morning was 101.2 taken rectally at Urgent Care clinic. Rash was first noticed following morning - All over red, pimply looking rash particularly on left leg (which received the injection). Red/warm on injection site, lethargy coinciding with fever.
This spontaneous report as received from a nurse at doctor's office, via sales representative refers to a patient of unknown age and gender. The patient's pertinent medical history or concurrent conditions were not provided. On an unknown date, the patient received a dose of ROTATEQ, oral, (lot number and expiry date was not provided). Co-suspect therapy and concomitant medications were not provided. It was reported that months ago (exact date not provided), a patient had rotavirus after receiving ROTATEQ. At the time of the report the patient's outcome and the relatedness between the event and suspect therapy were not provided. Additional information has been requested.
patient felt that his  heart rate went up, feeling shaky,  pale, feeling nausea, shortness of breath,  overall not feeling good after 3 minutes of getting the vaccine  We made him lie down in supine position and he felt a little bit better, he was also feeling low on energy as he had not had much to eat all day except a oat meal shake this afternoon, was also not well hydrated.
shingles; were bad; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number 95XF7, expiry date 31st October 2020) for prophylaxis.   On 31st October 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In November 2019, 1 week after receiving Shingrix, the patient experienced shingles and feeling bad. On an unknown date, the outcome of the shingles and feeling bad were recovered/resolved.   It was unknown if the reporter considered the shingles and feeling bad to be related to Shingrix.  Additional details were reported as follows:  About one week after receiving dose of Shingrix she developed shingles.  The patient stated they were bad for a week, and then resolved. The reporter consented to follow up. This case has been linked with US2020075700, reported by same reporter.
Fever (101.7), chills, nausea, severe headache and neck pain bruising on arm at injection site
I have been experiencing cold like symptoms for one week.  The symptoms are net improving after a week. I am healthy and have a excellent health history and started taking vitamin D supplements approximately 4 years ago. I was exposed to covid several times before being vaccinated and never had any symptoms. Since the vaccine isn?t reducing transmission was it necessary for me to have.  My fear is that it has negatively impacted my immune system.  I have never had a cold like this that lasted this long. Thanks for your consideration.
This spontaneous report as received from a health care professional refers to unspecified number or patients of unknown age and gender. On unknown dates, between October 2014 and December 2014, the patients were vaccinated with improperly stored doses of ZOSTAVAX, (dose, route, lot number and expiration date not reported). No symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient is a 70 year old female that is post-menopausal. Her first Moderna vaccine dose was given on 2/4/21. Exactly one week later on 2/9/21, the patient had vaginal bleeding that lasted one day. There were small clots in the blood that was discharged. The patient went to the doctor where a urinalysis was performed. The patient had a positive urinalysis and was started on antibiotics. The patient's second dose was on 3/4/21. Exactly one week later on 3/11/21, the patient had vaginal bleeding that lasted a day.  Patient usually takes aspirin 81mg daily, however she stopped this medication prior to both doses being administered. She restarted the aspirin after each Moderna dose.
Difficulty breathing for 30-40 seconds; A spontaneous report was received from a (Reporter like HCP or Consumer) concerning a 66  Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273). The patient's medical history was not provided. No relevant concomitant medications were reported.   Patient stated that he received his 1st dose of the Moderna COVID 19 vaccine on 11JAN2021 at Health Department. Within a minute of receiving the vaccine he had difficulty breathing for 30-40 seconds. Patients stated that he did not take anything to alleviate the symptoms. Patient called his doctor's office and he was asked to call Moderna. Consent given for safety to follow up.Site for the injection was upper  right arm. The outcome of the event was unknown
Symptoms began 11/16/02; patient had fever, rendess, swelling and itching at site of injection localized to left deltoid muscle region; Raised nodule noted, no blisters, no red hives, no drainage, no open areas; treatment to continue, monitoring symptoms.
Chest pain severe and tightness with increased activity.  Increased heart rate, fatigue, cold sweats.
Numbness in perioral region - predominantly from frenelum to bottom of inside of upper lip, both sides of lip (interior of mouth) and inside lower lip. Circumfrential numbness and tingling, affects taste. Taste and smell remain intact. No obvious edema noted to outer lips.
22 y/o old AD male presentig to clinic for profile recommended by Cardiology after recent ER visit and subsequent hospitalization. Pt went to the ER on 23OCT18 for chest pressure associated with cough, SOB, rash and fatigue. He had had smallpox and anthrax vaccination on 11OCT18. Pt states chest pressure symptoms began following a ruck march on 18OCT18. By 20OCT18, he had developed fatigue, chills, subjective fevers, sweats, disorientation, and rounded papular, non-blanching, mildly pruritic, non-ulcerative rash that began on L flank/buttock, and spread to R and L shoulders/upper arm, neck, face, and R arm. During PT on 23OCT18, the patient had non-radiating diffuse chest pressure, fatigue, SOB, and cough and could not complete PT. Symptoms were improved with rest, worse with exertion/movement. Ibuprofen seemed to numb the pressure, but did not help. Pt had elevated cardiac enzymes in ER and was admitted to hospital and observed x 2 days, over which time the rash resolved but some chest pressure still remained at time of discharge and currently. TEE, CT, Cardiac MRI, and chest x-ray during hospital stay were unremarkable. No travel. Recently completed work 9/18. No orthopnea, edema. Patient had multifocal PNA treated with Levaquin 5 months ago. No surgeries, allergies, medications, FH of sudden cardiac death or autoimmune disease.
Frequent soreness in left pectoral muscle & left shoulder. Left pectoral muscle feels very sore and soreness has spread to ribs on left side
Fever 102 degrees for 36 hours. Swollen lymph glands in axilla, redness, hot cellulitis. Secondary infection severe histamine reaction/chest congestion.
Janssen COVID-19 Vaccine EUA Woke up with extreme chills approximately 11-12 hours from receiving shot. Once I had them under control by adding a ton of blankets, fell back to sleep. Next woke up approximately 2 hours later with a very bad headache. Got up and took 800mg ibuprofen. Fell back asleep. Woke up later with sweats. Throughout the following day, keep headache under control with more ibuprofen.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown ages and genders. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ orally (lot # L027719, expiry date: 28-APR-2017; lot # L035637, expiry date: 07-MAY-2018) (incorrect product storage). No adverse effect reported. The outcome of the events was unknown. This is on of the several reports from the same reporter. Additional information has been requested.
Infective endocarditis.  Had been previously discharged to home for home antibiotics with IV Vancomcyin. Unfortunately had missed doses and relapsed to using to methamphetamine and heroin. Was admitted through 12/23 for IV abx. He will follow up with ID and PCP post discharge, ordered. He was medically stable for discharge. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine
I was to administer ACTHIB, but I only gave the diluent. TC to return my phone call. Will follow. 11/21/2012 - 10:38 TC I instruct that the Hib will need to be re-administered because I only gave the diluent. This will be at next immunization clinic. 1/18/2012 HIB given 1/2/2013.
Starting in November it was a incidental finding. I was having issues with my pulsometer so I tested it on my self and the wave form was very abnormal. After checking on one of my peers and she came back with normal with a normal wave form. I placed EKG stickers on ,myself and discovered a sinus rhythm with frequent premature atrial contractions. My heart rate was 95 but I was only profusing at a rate of 60. I spoke to a fellow provider and he had me to put on his Apple watch and check my EKG which read Atrial Fibrillation. My doctor advised me that it could flip into A-Fib at any time. I went to the ER and had EKG and full workout. No heart attack was detected but I was still in this arrhythmia.  By January, I made an appointment with a cardiologist and had an EKG. He indicated that he thought it was my thyroid and put me on a strong beta blocker. I was prescribed Metoprolol 50mg and asked me to double the dose to 100 mg. I was able to tolerate the 50 with just feeling tired. When I switched to 100 mg, I was at work and could hardly get out of my chair. I checked my heart rate which was at about 40. My blood pressure was 90/40. I immediately stopped the medication. I was sent a halter monitor in the mail. I wore it for 3 days. I noticed that when attempting to climb stairs I was short of breath. The completed an echocardiogram. My ejection fraction went from 73 to  61%. The cardiologist referred me to an Electrophysiology Cardiologist. I was able to see him in middle June. He showed me the results of the halter and told me I was on the verge of going into A-Fib. He placed me on a different medication and stopped the Metoprolol all together. I had Thyroid lab completed and the results were normal. I was placed on Plaquenide and Cardizem. I am still having the same symptoms of shortness of breath and lack of energy. I do want to add that I was survivor of  Cancer an received Taxol which the doctor thought could be related.
INCREASED HEART RATE; NUMBNESS; TINGLING; SLURRED SPEECH; CONFUSION; OUT OF BREATH; A spontaneous report has been received from a consumer. The report concerns a female patient (age 31 years, height 60 in, weight 160 lb).    No medical history was reported.     Concomitant medication included Cosentyx for psoriatic arthritis, autoimmune condition.     The patient received Flumist Quadrivalent (influenza virus vaccine live, intranasal) once/single administration, via nasal route, for prevention on 03-JAN-2021.     On 04-JAN-2021, the patient experienced increased heart rate (preferred term: Heart rate increased), numbness (preferred term: Hypoaesthesia), tingling (preferred term: Paraesthesia), slurred speech (preferred term: Dysarthria) and confusion (preferred term: Confusional state). On an unknown date, the patient experienced out of breath (preferred term: Dyspnoea).     At the time of reporting, the event of out of breath was ongoing. At the time of reporting, the event of increased heart rate was improving. The outcome of the event(s) of numbness, tingling, slurred speech and confusion was unknown.     The events were considered non-serious.     Laboratory values are available.
This spontaneous report as received from a nurse refers to an unspecified amount of patients. Concomitant medication and patient medical history were not provided. The nurse reported that GARDASIL (injection, dose, route, frequency and indication were not provided) that underwent a temperature excursion had been administered. No adverse effect reported. This is one of several reports received from the same reporter. This is one of  several reports received from the same reporter. Additional information has been requested.
Pain at injection left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at injection left arm) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection left arm). On 02-Mar-2021, VACCINATION SITE PAIN (Pain at injection left arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment information was not provided.  Concomitant product use was not provided by the reporter.
Narrative:  This patient received two doses of Pfizer COVID 19 vaccine in Jan/Feb 2021. The patient presented to the ED on 28 June 2022 with fever, cough, and shortness of breath. The patient was admitted to the hospital with Covid pneumonia and tachycardia. The patient was treated with remdesivir, dexamethasone, and inhalers. The patient was discharged on 30 June 2022 in stable condition. Reported per EUA.
Information has been received from a registered nurse, for VARIVAX, a Pregnancy Registry Product, concerning a female patient of unknown age with none pertinent medical history. The patient's history of previous pregnancies and live births was not known. The patient was vaccinated with a dose of VARIVAX (lot number G007814) (dose, route not reported) on 14-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. On an unknown date, the patient became pregnant. Pregnancy was normal to date. There was no treatment given for adverse event. Pregnancy test was performed. Initial exposure to VARIVAX was at 3 week. The patient's LMP was an approximately 20-AUG-2012 and her EDD was reported as on 27-MAY-2013. The patient sought medical attention, contacted clinic. Additional information has been requested.
Arm soreness; a little fatigue; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Arm soreness) and FATIGUE (a little fatigue) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L22A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient shared that he had COVID last November) in November 2020, Hypertension since an unknown date and Cholesterol since an unknown date. Concomitant products included ATORVASTATIN for Cholesterol, LOSARTAN for Hypertension.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness) and FATIGUE (a little fatigue). On 05-Feb-2021, PAIN IN EXTREMITY (Arm soreness) and FATIGUE (a little fatigue) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Feb-2021 and was forwarded to Moderna on 08-Feb-2021.    This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Arm soreness) and FATIGUE (a little fatigue) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L22A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient shared that he had COVID last November) in November 2020, Hypertension since an unknown date and Cholesterol since an unknown date. Concomitant products included ATORVASTATIN for Cholesterol, LOSARTAN for Hypertension.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness) and FATIGUE (a little fatigue). On 05-Feb-2021, PAIN IN EXTREMITY (Arm soreness) and FATIGUE (a little fatigue) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were reported.
This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 82-year-old male patient who received SHINGRIX (batch number N79Z5, expiry date 31st January 2020) for prophylaxis. On 17th January 2019, the patient received the 2nd dose of SHINGRIX. On 19th January 2019, 2 days after receiving SHINGRIX, the patient experienced dizziness, balance disorder and headache. On 20th January 2019, the patient experienced tiredness. On an unknown date, the outcome of the dizziness was not recovered/not resolved and the outcome of the balance disorder and tiredness were unknown and the outcome of the headache was recovered/resolved. It was unknown if the reporter considered the dizziness, balance disorder, headache and tiredness to be related to SHINGRIX. Additional details were provided as follows: The patient received his 2nd SHINGRIX dose in right arm. Two days later he experienced headaches that would keep him awake at night, but resolved later in the morning upon awakening. They lasted for 3 days. He also noted he began to feel dizziness that was very bad in the morning, got better throughout the day, but it had not resolved as of this call. He notes his balance is off, he was worried to do his usual things like walking. He also stated he noticed being tired on the 20th, he was out picking up sticks, which was not uncommon, and he continues to be tired as of this call when he exerts himself. The patient had an appointment with his physician. The reporter gave consent to follow up.
received the entire vial contents (0.45 mL), without dilution; Four of the eight workers were hospitalized as a precaution after experiencing flu-like symptoms from the overdose; This is Spontaneous report from 2 contactable Nurses, 2 contactable physicians and a contactable Pharmacist. These Nurses, physicians and pharmacist reported similar events for 4 patients. This is a 4th of 4 reports.  A patient of unknown age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unknown route of administration at single dose (first dose) for unknown indication. Medical history and concomitant medications were not reported. Eight healthcare workers in a long-term care (LTC) facility received the entire vial contents (0.45 mL), without dilution, for their first dose of the Pfizer-BioNTech vaccine. Four of the eight workers were hospitalized as a precaution after experiencing flu-like symptoms from the overdose. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The reported Flu-like symptoms was associated with the accidental overdose, received the entire vial contents (0.45 mL) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), without dilution. The case will be reassessed should additional information become available.  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.,Linked Report(s) : US-PFIZER INC-2021032445 same reporter/SD, AE/ different patient
Client received a booster dose of Moderna (0.25ml) (Lot #035C21A and exp: 12/30/2021) in the left arm at 3:32PM administered by RN. After administration, RN noted the client was supposed to receive a 2nd dose of Moderna (0.5mL) and alerted RN. RN elevated the information to Vaccine Operations Lead. Per CDC guidance Vaccine Operations Lead, recommended administration of a Moderna dose (0.25mL) in the opposite arm. RN provided education to the client regarding error and CDC recommendation of administration of a dose of Moderna (0.25mL) in the right arm. RN also provided education regarding s/s of anaphylaxis and when to seek EMS. The client voiced understanding of this education and provided verbal consent to receive a dose of Moderna (0.25mL) in the right arm. The client received a dose of Moderna (0.25mL)(Lot #035C21A and exp: 12/30/2021) in the right arm. The client did not report any symptoms during the observation period. The time the client left was not noted.
Swollen sinuses, ear discomfort and tinnitus and hearing loss.  I have never had hearing loss , was tested in 2020.  Now I .Have had tinnitus since 12/25/2022 and hearing loss in both ears.  All this post bivalent booster shot.
RA red, swollen, very sore. Also c/o stiff neck, dizziness, back pain. S/S started approx 2 days after injection.