chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Right leg aching for 1 hr, then both legs below knee aching for 2 hrs, then pain moved to right arm. In PM, redness and bruising to upper right arm at site of anthrax vaccination.  Day 2 aching in arm continued, readness expanded, area hot and firm.  Saw doctor early PM. Will watch red area. Returned day 3 AM. Redness and firmness expanded, ache continued.  Diagnosis cellulitis. Prescribed doxycycline. Redness continued to expand covering most of upper arm. Returned to doctor day 4 PM. Admitted. Given Clindamycin via IV. Responded well.  Released noon day 6. Continue on clindamycin pill for 5 days.
Janssen COVID-19 Vaccine EUA   swelling of lips, itchiness of palate and eyes; occurred within 15 minutes of vaccine administration and took Benadryl Allergy Liqui-Gels at vaccine site medical station
My head feels like it is on fire. I have swelling in my neck and spine area. I am numb throughout my body, and I feel tingling all over. I break out in rashes that turns red. I also have red rashes in my mouth. I can't hardly see because there's a blur. My nose and forehead got pressure. My legs feel like they got fluid in them all the way up to my back. My feet stay cold. The inside of my mouth swells also. I feel hot but I'm not running a fever. I went to see my doctor at Mental Health office. I was diagnosed with mono. I was prescribed doxycycline 100mg 2xday. I can't even function and my mind is foggy.
Diagnozed with influenza strain A; This is a spontaneous case reported by other health professional (nurse) to Company (reference number: SEQ20-00664) and initially received on 18-Feb-2020, concerning a 44-year-old, female patient.  The patient did not have any medical history.  The patient did not take any concomitant medications.  On 08-Oct-2019, the patient was administered Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location: deltoid, batch number: 261204, expiration date: 26-Jun-2020 and route of administration: intramuscular) as influenza prophylaxis.  On 10-Feb-2020, the patient was diagnosed with influenza strain A. The patient went to doctor and received Tamiflu (oseltamivir phosphate).  At the time of this report, the patient was recovering from the event.  The event of influenza was considered as serious due to criterion of medical significance, per company.  The reporter assessed the case as non-serious and did not provide causality assessment to Flucelvax Quadrivalent.  The case is linked to the case 202001856 due to same reporter.  Company comment: The patient experienced influenza after vaccination with the suspect product, Flucelvax Quadrivalent. Chronology is plausible. No medical history, concomitant medications and diagnostic findings were provided. Considering all the above mentioned, causality between suspect product and the event is assessed as related.; Sender's Comments: The patient experienced influenza after vaccination with the suspect product, Flucelvax Quadrivalent. Chronology is plausible. No medical history, concomitant medications and diagnostic findings were provided. Considering all the above mentioned, causality between suspect product and the event is assessed as related.
Rash, hives, throat discomfort, treated with 1 dose of IM epinephrine, benadryl, pepcid, solumedrol, and albuterol
The patient has not experience any adverse events, but the vaccine was inadvertently administered within 1 month of the patient receiving monoclonal antibody therapy (BAM infusion) for COVID-19. The facility that provided the patient's information did not indicate he had received the infusion, yet after vaccination they reported he had in fact received the BAM infusion on 1/4/22.
Allergic Reaction within 10 minutes:  Large itchy hive on forehead, a red rash on both hands, headache, mild dry cough.  After 40 minutes of observation by a hospital nurse, I went home and took an allergy pill, as advised (Benedryl).  I am recovered.
Dizziness- followed-up by syncope & pallor. TRENDELENBURG position, after approximately 2 minutes color back. Kept patient approximately 1/2 hour for observation.
Ringing in ears that will not stop, muffled ears like hearing loss, full head feeling like stuffed ears, dizziness
2 1/2hr post vax screaming x 6hr non-stop @ inj sit very swollen & red, T103;treat inj site w/ice (handicapped-mentally retarded);MD rx APAP by phone;
Eyes became gooey and hazy.  Fever. Aches in left side of body.  Overall Fatigue.
Seizure, 1 week, post vax, lasting about 30-40 seconds. Eyes rolled back, fell unconscious, mild shaking of limbs. Very fatigued for several hours after seizure. On 4/28/01, had 2nd seizure about 30-40 seconds long and fell unconscious, eyes did not roll back and mild stiffness of extremities. Not yet recovered.
No adverse event; patient received one dose of Moderna Covid vaccine and a second Pfizer covid vaccine; patient received one dose of Moderna Covid vaccine and a second Pfizer covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (patient received one dose of Moderna Covid vaccine and a second Pfizer covid vaccine), COVID-19 IMMUNISATION (patient received one dose of Moderna Covid vaccine and a second Pfizer covid vaccine) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (COMIRNATY) for an unknown indication.    No Medical History information was reported.   On 11-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 30 microgram. On 12-Apr-2023, the patient received second dose of TOZINAMERAN (COMIRNATY) (unknown route) 1 dosage form. On 12-Apr-2023, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (patient received one dose of Moderna Covid vaccine and a second Pfizer covid vaccine) and COVID-19 IMMUNISATION (patient received one dose of Moderna Covid vaccine and a second Pfizer covid vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (patient received one dose of Moderna Covid vaccine and a second Pfizer covid vaccine), COVID-19 IMMUNISATION (patient received one dose of Moderna Covid vaccine and a second Pfizer covid vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant medication was not reported. Vaccine was the adult gray cap monovalent vaccine.  Treatment drug was not reported.
This spontaneous report as received from aunt and caregiver of the patient refers to a 20 year old female patient (age reported as "20", unit approximated to years from the context of the source document). The patient was mildly autistic, she was diagnosed at the age of 7 (units not provided). Patient's historical drugs included an unspecified chicken pox vaccine which the patient received as a child (date unspecified). The patient's medical history included being extremely withdrawn. On unknown dates, reported as 4-5 years ago, also reported as at the age of 15 or 16, the patient was vaccinated with the three dose regimen of GARDASIL route reported as injection (dose, anatomical location and lot numbers were not reported). Concomitant medications were not specified. On an unknown date, reported as within a few days of the first GARDASIL dose, the patient became much more social and affectionate, whereas before she was extremely withdrawn. The medical attention had been sought, the reporter mentioned the event to the healthcare professional (HCP). The outcome of became much more social and affectionate, whereas before she was extremely withdrawn was unknown. The relatedness between the event and GARDASIL was not reported. Additional information has been requested.
One week and one day after receiving the vaccine, I noticed a red, very stiff-feeling, rash-looking area encompassing nearly the entire front upper shoulder of my arm at the injection site. It was itchy, but slowly declined in itchiness, and it felt warmer than the rest of my skin. There was no pain. The next day, the stiffness and redness was almost gone but still noticeable. Two days later, it was completely gone. When looking it up, I saw the term "covid arm" being used.
brain injury; Idiopathic Ataxia; now cannot walk or talk; now cannot walk or talk; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 51-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) at the age of 51 years and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BRAIN INJURY (medically significant), outcome "unknown"; ATAXIA (non-serious), outcome "unknown", described as "Idiopathic Ataxia"; GAIT DISTURBANCE (non-serious), SPEECH DISORDER (non-serious), outcome "unknown" and all described as "now cannot walk or talk". Clinical Course: The patient received the two Pfizer vaccines and shortly after spent time in the hospital. Undiagnosed, but diagnosed with a brain injury, with the side effect of Idiopathic Ataxia, at the time of reporting cannot walk or talk. The patient was in good shape.  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 temporal association, the causal relationship between BNT162B2 and the events, brain injury, Ataxia, speech disorder, Gait disturbance cannot be completely ruled out. 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.
Diagnosed with COVID/Allergy like symptoms/A little tired/Nasal congestion/runny nose; Maybe a concern vaccine lot might have been bad/not good; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with COVID/Allergy like symptoms/A little tired/Nasal congestion/runny nose) and DRUG INEFFECTIVE (Lack of drug effect) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 039K20A) for COVID-19 immunisation.     Concurrent medical conditions included Penicillin allergy (possible amoxicillin) and Allergy to intravenous contrast media (IVP dye).   On 12-Jan-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021 at 9:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Diagnosed with COVID/Allergy like symptoms/A little tired/Nasal congestion/runny nose) and DRUG INEFFECTIVE (Lack of drug effect). On 16-Mar-2021, DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown. At the time of the report, COVID-19 (Diagnosed with COVID/Allergy like symptoms/A little tired/Nasal congestion/runny nose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.         The patient reported taking no concomitant medications.  The patient stated that she had no reaction to the vaccine. She had a rapid COVID-19 antigen test on 16-Mar-2021 when she was fully vaccinated, and tested positive. The only reason the patient got tested was due to her non-vaccinated husband and son testing positive. She only experienced allergy-like symptoms (reported as nasal congestion and runny nose) for about 4-5 days and was a little tired. The patient also reported maybe a concern the vaccine lot might have been bad/not good. The patient had no treatment. This is a case of lack of efficacy of the vaccine. Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of COVID-19 is assessed as not applicable.   This case was linked to MOD-2021-185476 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2021: Upon internal review on 11-AUG-2021, an event lack of effect was added to the case. On 27-May-2021: Completed VAERs form. Event of poor quality vaccine administered added. Event of COVID-19 updated. Event of nasopharyngitis removed (considered symptom of COVID-19).; Sender's Comments: This is a case of lack of efficacy of the vaccine. Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of COVID-19 is assessed as not applicable.
8 days p/vax pt exp joint pain, ear pain, throat discomfort, dizziness & possible temp;instructed Ibuprofen & liquids;pt also has wisdom tooth coming;
Patient had an allergic reaction. Onsite EMS was called vitals HR 106 BP 114/76  100% O2. Patient treated, transported the hospital.
Out of sorts and dizzy; Out of sorts; Heaviness in his upper chest and shoulders; Heaviness in his upper chest and shoulders; Felt wobbly; sneezed 4x in rapid succession then he felt like he couldn't breathe; Felt like his heart or left lung was going to burst; Aches and pains in his body like he had the flu; Sneezed 4x in rapid succession then he felt like he couldn't breathe; This is a spontaneous report from a Contactable consumer (patient). A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/lot number: EL9264) via unspecified route of administration, administered to right shoulder, on 04Feb2021 at 9 AM, as unknown dose, single for COVID-19 Immunisation. Medical history included bipolar disorder. The patient's concomitant medications included testosterone undecanoate (AVEED) taken for hypogonadism, start date was unknown and it was ongoing; Lithium Carbonate taken for Bipolar disorder, start date was unknown and it was ongoing; Valproate semisodium (DEPAKOTE) taken for Bipolar disorder, start date was unknown and it was ongoing; lurasidone hydrochloride (LATUDA) taken for Bipolar disorder, start date was unknown and it was ongoing; Levothyroxine sodium (SYNTHROID)taken for Hypothyroidism, start date was unknown and it was ongoing; Pantoprazole taken for Gastrooesophageal reflux disease (GERD), start date was unknown and it was ongoing; quinapril taken for blood pressure high, start date was unknown and it was ongoing; Metformin taken for diabetes, start date was unknown and it was ongoing; Mirabegron (MYRBETRIQ) taken for Urine abnormality, start date was unknown and it was ongoing. Caller stated that he had adverse effects immediately after getting the injection. On 04Feb2021 (also reported as: less than 30 seconds after the injection), the patient experienced like out of sorts and dizzy. He stood up and walked to the observation area and had a heaviness in his upper chest and shoulders and felt wobbly. After 15 minutes, he stood up and went to his car and felt almost normal. When he got home, about 2 hours later, he sneezed 4 times (4x) in rapid succession then he felt like he couldn't breathe. Stated that he had to try to stay calm and tried to relax, and almost immediately it felt like his heart or left lung was going to burst, but it went away after a second. Stated that about 2 hours later he had aches and pains in his body like he had the flu, and that lasted for about 30 minutes, then they went away. The patient's history of all previous immunization with the Pfizer vaccine considered as suspect was none. The patient did not received any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. On 04Feb2021 at 2:30 PM, the outcome of the events were recovered.    Follow-up attempts completed. No further information expected.
Staff was administering vaccine to L-delt. Syringe leaked around the needle and less than half dose was administered. Full dose administered to R-delt per CDC recommendation. Pt monitored for 15 minutes after vaccination.
Information has been received from a medical assistant referring to a 4 years old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 16-JUN-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K021151 with expiration date 02-NOV-2016; dose and route of administration were not reported)(Incorrect product storage). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Vaccination was given in the right deltoid.  The patient reported her deltoid area started to swell about 6 hours later.  She also reported the area was swollen and very sore.
platelet count decreased to 30K on 6/21/21, then 7/9/21 15K, 7/12/21 20K, 7/13/21  21K  started on dexamethasone  on 7/21
COVID; COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 26Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 37 years, all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "recovered" (2022) and all described as "COVID".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
L arm. 1/2 dollar raised welt on arm, burning sensation, hurts to raise arm, defined area circular pillows within the area "bubbled" appearance. Pt was sent home from school.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age. No information about medical history concurrent conditions and concomitant medications was reported. On 05-MAY-2014 the patient was vaccinated with an improperly stored (Oka/Merck) VARIVAX dose 0.5 ml, route subcutaneous. The reporter also stated that the (Oka/Merck) VARIVAX reached a high temperature of 19F for a total of 14 hours over multiple excursions. No adverse effect reported. The outcome of events reported is unknown. No product quality complaint was involved. This case is linked to the case 1405USA004602 via same reporter link. Additional information has been requested.
4:55 patient in general observation, itching back and back of right arm. Ambulated without difficulty to private observation area. Per exam, noted red flat rash on right back area directly behind under arm. Mild red rash on upper back of right arm. Patient states site is very itchy. Denies throat itching. No SOB noted. BP 140/80; HR 71; O2 98% on r/a.  4:59 patient accompanied by husband and will be transported home per husband. Benadryl 25 mg PO given (dosed per patient), drank 4 oz water with med without difficulty swallowing. BBS CTA, no stridor noted. Ice packs given for comfort.  5:10 states ice is relieving itching, redness decreasing. HR 75; O2 99%  5:15, discharged ambulatory with husband to private vehicle. Husband driving.
Headache, fever 102.2, joint aches, all over aches and tiredness.  Lasted 36 hours.
113 Bivalent doses administered after the BUD to patients 12 and up.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.).    No concomitant medications were reported.  It was unknown if the patent had received any other vaccines in the 4 weeks prior to COVID-19 vaccine.    No treatment drugs were reported.
Suspected vaccination failure/My shingles shot didn't work; My shingles shot didn't work; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details provided were as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated that the Shingles shot did not work for him/her and experienced shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Pt called at 1800 we gave the vaccine at 1630. She complained of tightness in the chest and "having to concentrate on breathing." I recommended an ER visit ASAP.
This Case was reported by the mother of a consumer via another manufacturer and described the occurrence of listlessness in an infant female subject who was vaccinated with (Diphtheria and tetanus and acellular pertussis, manufacturer unspecified) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date, 21 years ago, the subject received unspecified dose of Diphtheria tetanus acellular pertussis (unknown) . At an unspecified time after vaccination with Diphtheria tetanus acellular pertussis, the subject experienced listlessness, pallor, limpness, refusal to nurse and whimpering. At time of reporting the outcome of the events was not specified.