chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 4-5 days after vaccination, I started having what I thought was food poisoning with intense abdominal pain with nausea and vomiting. On 1-31-2021, I went to the local ER with the same symptoms. They ordered a CT of the abdomen which showed moderate diffuse wall thickening of the gastric body and antrum in non specific gastritis. Also showed diffuse hypoattenuation of the liver compatible with steatosis or other hepatopathy. They done blood work as well which did not show much of anything abnormal. They gave me prescription for omeprazole and gave me a GI cocktail/ZOFRAN. They gave me a diagnosis of Gastritis. I was sent home and within 24 hours, I had chest pain. I called my primary care physician's office and went in for a visit on 2-3-2021. They ordered an EKG and troponin. Both came back normal. He also ordered a nuclear myocardial stress test. I continued to have chest pain over the next several weeks and I was referred to a GI specialist on 2-15-2021 and he ordered nitroglycerin as needed. The Nuclear stress test was done on 2-24-2021 which showed hypertensive response. In May 2021, I was referred to a cardiologist who ordered a CT angiogram that was done on 6-14 which showed elevated coronary calcium deposits at LAD and I also had an Echocardiogram which showed a trace pericardial effusion. I am feeling a lot better now and symptoms have resolved.
rash on stomach, back, thighs & tips of feet; tx w/DPH;
SEVERE SIDE EFFECTS POST VACCINATION; This spontaneous report received from a patient via a company representative 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, intramuscular, batch number: Unknown) 0.5 ml, start therapy date was not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced severe side effects post vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe side effects post vaccination was not reported. This report was non-serious.
A few Minutes after getting the vaccine,  patient stood up, felt dizzy light headed and nauseas and then passed out. Patient was unconscious for approximately 5 seconds before waking up.  Patient was then assisted to a supine position before getting a set of vital signs, all WNL except for a low blood pressure.  Patient was then assisted to a cot where she explained how she felt before hand and another set of vital signs was taken, all WNL and an improved blood pressure. Patient was then asked to wait at least 30 minutes and until all symptoms had subsided before having someone assist her in getting home.
Experienced shortness of breath, worsen around 7 pm - couldn't breathe. Calm herself down to feel better. Stayed up all night. Mom (nurse) checked pulse and was fine. Weak today but feeling better. FYI side effects of medications is shortness of breath.
Dizziness, like going to faint. Last for about 10 seconds or so then goes away. Started noticing about an hour after shot on yesterday and still happening several times in an hour. I did not get this after first dose, only after second dose
ELEVATED HEART RATE; CHILLS; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma. 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. Per procedure no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced elevated heart rate, chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated heart rate, chills, and fever. This report was non-serious.
Right arm numbness/tingling, slight right hand swelling,  and weaker grip with right hand. I am able to move my  Right arm, right fingers, and right arm at liberation.
Information has been received from a new article via an journalist in a website referring to unspecified number of patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with doses of GARDASIL (dose, dose number, lot number, application and route were not reported). According to the research of Centers for Disease Control and Prevention, the researchers looked at problems reported to the Vaccine Adverse Events Reporting System in the 2.5 years since GARDASIL was licensed. There were 0.2 blood clots per 100,000 doses. The outcome of event blood clots was not reported. The causality was unknown. This is one of several reports received from the same source. Additional information is not expected since there was no contact details provided.
Chills, body aches, fever (100.5 F when measured 9 hours after start of symptoms).
Information has been received from a health professional concerning an unidentified patient who was vaccinated with a first and second dose of varicella virus vaccine live and did not seroconvert. On 08/03/2000 the patient was vaccinated with a 3rd dose of varicella virus vaccine live. The patient was treated with Depo-Medrol. Unspecified medical attention was sought. Additional information has been requested.-
Swelling around the site started day of vaccination.  By Monday was swollen considerably with extreme itching and redness and rash down to the elbow.
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66 year-old female patient received bnt162b2 (COMIRNATY), administration date Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Family history included: "lupus" (unspecified if ongoing), notes: my sister has lupus; "Covid" (unspecified if ongoing), notes: My daughter and grand daughter got Covid; "taste issues" (ongoing), notes: they are still having taste issues; "memory problems" (unspecified if ongoing), notes: memory problems, it was a nasty little disease. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm".  Additional information: The first week of January, patient received the 1st dose, and she was fine other than a sore arm.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Symptoms within 10-15 mins of the dose: SOB, Dizziness, heart was racing
Mom reports that he has been very cranky and fussy since vaccines given on 11/22/05. T 99.2. Legs also really swollen.
Patient received vaccine 7/27/12. Patient developed red ring at administration site which lasted till 8/5/12. Patient develop hives, swollen face on 8/9/12 MD diagnosed patient has developed shingles.
vasovagal syncope, excessive sweating, vomiting all occurring within the first 15-20 minutes after vaccination and lasting 1 hour
Rash/Urticaria (scattered) to both arms, both legs, chest and upper back. Tingling to throat. (Resolved on 10/5/16).
Patient stated that she couldn't use her left arm (arm of administration) for two weeks after administration of SHINGRIX. She also said her arm was red, swollen, and hot to touch for two weeks. She informed her PCP of RXN after the event and denied needing treatment.
Injection site reaction resulting in large area of arm and shoulder blade swollen, hard, hot and painful.
positive for COVID-19; positive for COVID-19; Left Arm Sore; got sick; head cold; This is a spontaneous report received from a contactable consumer (reporting on herself). A 84-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8734 and Expiration Date was not reported), via an unspecified route in Arm Left on 01Apr2021 11:15 as single dose for COVID-19 immunization. Medical history included food allergy from an unknown date and unknown if ongoing. There were no concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received her first dose of the BNT162B2 vaccine on 01Apr2021 and experience Left Arm Sore and reports that several days later, she got sick. She states that on 04Apr2021, she was around people who ended up testing positive for COVID-19 so she herself got tested, but it was inconclusive. She states she figured she was positive because she was around people who tested positive at the same time as she got sick. States they tested on 06Apr2021, and got their results on 08Apr or 09Apr2021. She states on 14Apr2021 she was retested and it came back positive for COVID-19. She states she was supposed to get her second dose on 22Apr2021 and would like to know if she was still okay to continue with that. Patient was concerned with how effective the shot will be if she were to proceed with getting it. She states that she does not feel sick with COVID-19 and reports having a "head cold" but that's it. She would like to know how much time she has to get her second dose of the Pfizer BioNTech COVID-19 vaccine if she received her first dose on 01Apr2021. She requesting guidance on how to reach her vaccina-tion provider for further guidance on possibly rescheduling her second dose of the Pfizer BioNTech COVID-19 vaccine. She states she was not given a phone number but was able to provide the vaccination location's address. Patient did not received any treatment. The outcome for event positive for covid-19, got sick, head cold was unknown and for event left arm sore was recovered on 14Apr2021.
Almost a leopard look, not like a regular rash.; There is a strange pattern on the upper half of her right thigh, very warm.; There is a strange pattern on the upper half of her right thigh, very warm.; This is a spontaneous report from female consumer (patient's mother). This old female consumer (patient's mother) reported patient (daughter). A 23-year-old female patient (age at vaccination: 23 year) received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number was not reported and expiry date: 31Aug2021), via an unspecified route of administration, in Arm Left, on 01Jun2021 at 09:30, as a single dose for COVID-19 immunization. The patient was taking Pfizer Covid Vaccine because just for health protection and for work. Vaccine administered was not at facility. There was no history of previous immunization with the Pfizer vaccine. There were no additional vaccines administered on same date of the Pfizer Suspect. The patient's medical history included patient breaks out in hives (so they were just wanting to watch her closely with this), allergic to amoxicillin, and Keflex family of medicines (patient was 3 years old). There was no family medical history relevant to adverse events and no other relevant tests. Concomitant medications included amoxicillin and keflex (CEFALEXIN MONOHYDRATE). The reporter was calling on behalf of her daughter who received the first dose of the Pfizer Covid 19 vaccine about an hour ago. About an hour and a half ago, there was a strange pattern on the upper half of her right thigh, whole area feels very warm on 01Jun2021. Almost a leopard look, not like a regular rash on an unknown date. She just wanted to get Pfizer's input and see about the side effects seen and stated they noticed it like 5 minutes ago, it's staying steady right now. The reporter asked has this been reported as a side effect and did she need to get her in to see someone or did we need to get ready for an allergic reaction. The reporter got response as I would not be able to say if she was having a severe allergic reaction or not and suggested they reach out to her HCP to ask if she needs to come in to be seen or if they should go to the emergency room. There was a product complaint. Outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
This spontaneous report was received from a nurse practitioner via company representative regarding a male patient of unknown age with asthma. The patient's medical history, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9, intramuscular, (dose, anatomical location, lot number and expiration date were not reported, it was unknown if the vaccination was the first, second or the third in a series of three injections for the patient. There was no concomitant medication reported. On an unknown date, the patient experienced a panic attack which resulted into an asthma attack immediately after received the dose of GARDASIL 9. The patient sought medical attention in the office and none laboratory diagnostic studies were performed. Unspecified steroid injection was given to the patient as treatment. At the time of the report, the outcome of the panic attack which resulted into an asthma attack was unknown. The relatedness between the events and therapy with GARDASIL 9 was not reported. Additional information is not expected because there was no consent for follow up.
Originally I filed last year, I had been having Ventricular Arrhythmia, I had a full workup. Normal Echo. Now, I was hospitalized June 17th with Takotsubo Cardiomyopathy and SAM w/ LVOTO in ICU. The workup reveals a scar on the heart. This is all since the Vaccine, no issues ever, prior to the vaccine.
baseball size swelling under her left arm; baseball size swelling under her left arm likely a swollen lymph node; pain in the top of the shoulder down to armpit; discomfort; low-grade fever of 99 F that went to 100.2 F then back down; fatigue; chills; muscles aches, soreness; headache; nausea; slight arm pain through the day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (slight arm pain through the day), PERIPHERAL SWELLING (baseball size swelling under her left arm), DISCOMFORT (discomfort), PYREXIA (low-grade fever of 99 F that went to 100.2 F then back down) and FATIGUE (fatigue) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma, Migraine and Sinusitis. Concomitant products included MONTELUKAST SODIUM (SINGULAIR) and ALBUTEROL [SALBUTAMOL] for Asthma, IBUPROFEN for Migraine.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced PAIN IN EXTREMITY (slight arm pain through the day). On 02-Feb-2021, the patient experienced DISCOMFORT (discomfort), PYREXIA (low-grade fever of 99 F that went to 100.2 F then back down), FATIGUE (fatigue), CHILLS (chills), MYALGIA (muscles aches, soreness), HEADACHE (headache) and NAUSEA (nausea). 02-Feb-2021, the patient experienced ARTHRALGIA (pain in the top of the shoulder down to armpit). On 03-Feb-2021, the patient experienced PERIPHERAL SWELLING (baseball size swelling under her left arm) and LYMPHADENOPATHY (baseball size swelling under her left arm likely a swollen lymph node). The patient was treated with IBUPROFEN for Fever, at an unspecified dose and frequency and MONTELUKAST SODIUM (SINGULAIR) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (slight arm pain through the day), PERIPHERAL SWELLING (baseball size swelling under her left arm), DISCOMFORT (discomfort), PYREXIA (low-grade fever of 99 F that went to 100.2 F then back down), FATIGUE (fatigue), CHILLS (chills), MYALGIA (muscles aches, soreness), HEADACHE (headache), NAUSEA (nausea), LYMPHADENOPATHY (baseball size swelling under her left arm likely a swollen lymph node) and ARTHRALGIA (pain in the top of the shoulder down to armpit) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, Body temperature: 99-100.2 (High) temperature elevated from 99 to 100.2F. On 03-Feb-2021, Body temperature: 98 f-99f (normal) Temperature elevated between 98 F and 99 F.         Concomitant medications Ibuprofen, Singulair, albuterol inhaler.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Updated the outcome of event
Information has been received from a Nurse Practitioner concerning a female with no pertinent medical history and no prior drug reactions who, in February 2007, was vaccinated with the first dose of Gardasil. There was no concomitant medication. The patient's second dose of Gardasil was administered in March 2007. The nurse practitioner reported that the patient developed colitis after she received her second dose of Gardasil. The lot numbers were not known. As of 30-OCT-2007, the patient had not recovered from the colitis. The reporter considered the colitis to be disabling. Additional information has been requested.
PATIENT EXPIENCED SIGNIFICANT REDNESS (APPROXIMATELY THE SIZE OF HER PALM) AND SWELLING AT THE INJECTION SITE ABOUT 24 HOURS AFTER RECEIVING THE VACCINE. SHE ALSO REPORTED THAT IT WAS HOT TO THE TOUCH. PATIENT WAS INSTRUCTED TO MONITOR SIZE OF THE RED AREA AND REPORT TO DOCTOR OR PHARMACIST IF REDNESS INCREASED OR SPREAD TO OTHER AREAS OF THE ARM.
This spontaneous report was received from a healthcare worker refers to multiple unspecified patients of unknown demographics. Information regarding patients' pertinent medical history, drug reactions/allergies and concurrent conditions were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored VARIVAX, injection (dose, frequency, route, lot and expiry details unspecified) reconstituted with properly stored sterile diluent for prophylaxis (incorrect product storage). The vaccines were exposed to a temperature excursion of 6 to 14 degree Fahrenheit for a time frame of 7 hours and 30 minutes. There were no previous temperature excursion. Data logger was involved. No adverse effects were reported.
administered an expired pentacel vaccine to a patient today with no reported adverse event; Initial information was received on 20-Jul-2023 regarding an unsolicited valid non-serious case received from other health professional. Live follow up information was processed together.  This case involves a 7 months old female patient who received an expired diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (vero)] vaccine to a patient today with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 7v (crm197) (Prevnar) for Prophylactic vaccination (immunisation); and hepatitis b vaccine for Prophylactic vaccination (immunisation).  On 20-Jul-2023, the patient received a  dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Suspension for injection (strength: standard) at dose of  0.5 ml once (1x) (lot number: UJ671AAA, expiration date: 13-May-2023, administration site: Unknown) via intramuscular route for Immunization (immunisation) with no reported adverse event (expired product administered) (latency: same day).  No lab data reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event administered an expired pentacel vaccine to a patient today with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
On the night of shots, pt had t105, seven days p/shots, pt had t107 & broke out in a rash on face, neck & body;
High fever, migraine, weakness in arms and shoulders, nausea, insomnia (all lasting about 72 hours)
Pt received Moderna at a Facility in April in error, she 16 and only eligible for the Pfizer vaccine. Pt's parents have been inquiring about receiving the 2nd dose but could not obtain any information. They called the Pharmacy after being referred.  RPh's did research and found CDC guidance allowing for Moderna use in those under 18 if the first dose had been given inadvertently. Parents were informed and patient received 2nd dose of Moderna.
recurrence of a former heart condition; 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 32 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "heart condition" (unspecified if ongoing), notes: I experienced a recurrence of a former heart condition I had when I was 19 a few days. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; Unknown Manufacturer), for Covid-19 immunization. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "recurrence of a former heart condition".  Additional information: Customer Verbatim: Hi Team, I was wondering if someone from the Pfizer Team could give me a call and listen to my story regarding the second covid vaccine. I am a 32 year old healthy individual, and I believe I experienced a recurrence of a former heart condition I had when I was 19 a few days after taking the second Pfizer vaccine. I submitted a VAERS report several months ago but haven't heard anything from them. I've been working closely again with  Cardiology for my current health needs.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Swelling, warmth, erythema right deltoid. Fever 9/18-9/22.