chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative:  78 yo male with PMH significant for HTN, HLD, T2DM, COPD, CKD, h/o drug induced AIN, tobacco use, CAD, PAD on aspirin, h/o factor V Leiden admitted 1/15 With R gangrenous toes. Hospital Course complicated by: need for R BKA 1/20 despite attempts to revascularize and subsequent AKA 2/4, several trips to ICU for SVT, desats, underwent LHC 2/11 found to have class 2 pulm HTN; Acute hypoxic respiratory failure 2/2 volume overload, COVID positive 2/16 and COVID PNA which prevented d/c to CLC 2/17, treated with dexamethasone (2/20-3/1) and remdesivir (2/20-2/25),  several protein malnutrition on tube feeds and most recently sacral abscess (surgery consulted to aspirate, patient refused evaluation) and associate hypotension worrisome for sepsis placed on broad spectrum antibiotics. Palliative care team met with wife on 3/7, and Pt passed on 3/11/22.
Headache, Sedation, Myalgia, Fever & NauseaVomiting Narrative:  Other Relevant History:
Erythema, warmth, pruritus of right arm from sub-deltoid area to elbow.
Blood Blisters; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported.On an unspecified date, the patient experienced blood blisters after receiving her first dose of the Covid-19 Vaccine. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Headache, 102 fever, diarrhea, nausea, dizziness, body aches for 17 days. Then continued sluggishness for another 7 days.
On the 8th day after vaccine, I had 24 hours of stomach ache, chills, fatigue, headache, backache, hip ache, and then stomach ache for a few days, and then totally fine; On the 8th day after vaccine, I had 24 hours of stomach ache, chills, fatigue, headache, backache, hip ache, and then stomach ache for a few days, and then totally fine; On the 8th day after vaccine, I had 24 hours of stomach ache, chills, fatigue, headache, backache, hip ache, and then stomach ache for a few days, and then totally fine; On the 8th day after vaccine, I had 24 hours of stomach ache, chills, fatigue, headache, backache, hip ache, and then stomach ache for a few days, and then totally fine; On the 8th day after vaccine, I had 24 hours of stomach ache, chills, fatigue, headache, backache, hip ache, and then stomach ache for a few days, and then totally fine; On the 8th day after vaccine, I had 24 hours of stomach ache, chills, fatigue, headache, backache, hip ache, and then stomach ache for a few days, and then totally fine; This is a spontaneous report from a contactable nurse (patient). A 65-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 11Jan2021 14:00 at SINGLE DOSE on Right arm for covid-19 immunisation. Medical history was none. No-covid-prior-vaccination. No Known- allergies. Concomitant medication included atenolol (TENORMIN), clonazepam (KLONOPIN), sertraline hydrochloride (ZOLOFT), atorvastatin calcium (LIPITOR [ATORVASTATIN CALCIUM]). No-other-vaccine-in-four weeks. Since 19Jan2021, On the 8th day after vaccine, I had 24 hours of stomach ache, chills, fatigue, headache, backache, hip ache, and then stomach ache for a few days, and then totally fine. AE-resulted-in: [Doctor or other healthcare professional office/clinic visit]. No treatment received. Covid-test-post-vaccination: included Nasal Swab, Pixel by Labcorp, covid test date on21Jan2021 was Negative. The event recovered in Jan2021.  Information about lot/batch number has been requested.
After 24 hours fever, chills, headache, and sore arm.   Two days following vaccine swollen lymph nodes.
My DD woke me up wanting to go to ER.  She could not breathe, used rescue inhaler 2X through out the night, heart pounding, very pale, dehydrated, nauseous, muscular pain, fever.  hooked up to EKG watched her heart rate sky rocket,ER Dr. had her shot up with dye and had a CAT scan done to rule out clots, and obstruction to heart(their words, not mine). We left after the Dr. decided it was safe to go home with instructions to return if symptoms come back.  she got the shot to enter her residency even though we asked for medical exemption would not give one, corporate health care. I truly HATE what is being done and hope they all hang.  now it is mostly in her spine along with nauseousness and head aches.
Got vaccinated on 04/18/2021 on Sunday. After one week got rash/redness on the vaccinated arm, thickness and swelling a bit. Arm also feels ichy. Having also a cough since Sunday ( 04/25/2021)
threw up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  An 11 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VOMITING (non-serious) with onset 2021, outcome "not recovered", described as "threw up". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
3rd pregnancy with a history of high blood pressure with two previous pregnancies. Expected due date 06/03/2022
Temperature of 100 degrees, nausea, diarrhea, body and joint aches, headache, swelling and redness at site.
date of death 5-14-22   Presented to ER with CP 3/22
Developed urticaria within 2 hours of vaccine. Rash began on chest and spread to her neck and on her face.
1st event on 03/05: swelling in right wrist and arm. Pain in shoulder and neck. 2nd event on 03/09, 03/13, 03/16: woke to throat closing,  gasping for air. Difficulty breathing and swallowing. 3rd event on 03/19 and continuing: severe tinnitus
sore throat, rhinitis, t102-104 on 27JUL; rash, enlarged cervical lymph glands;
45min p/vax father brought pt back to office & pt had gen urticarial rash;pt also lethargic w/bilateral wheezing;epi given;
Patient neverr developed antibodies to the GARDASIL; rheumatoid arthritis relapsed; This spontaneous report has been received from a physician (patient's father) regarding a 19-year-old non-pregnant female patient. The patient's concurrent conditions included latex allergy. Medical history included rheumatoid arthritis. Historical drugs included methotrexate 15 mg, weekly for rheumatoid arthritis. Concomitant medications were no reported.  On an unspecified date in 2013 (also reported as "7 years ago", conflicting information), the patient received her first dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) or HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (reporter was not sure which of the vaccines was administered to the patient) (strength, dose, and anatomical location were not provided), intramuscularly (IM) as prophylaxis. On an unspecified dates between 2013 and 2014 (reported as "the patient had the 3-dose series in 2013 and 2014"), the patient received the second and third doses, respectively, of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) or HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, and anatomical location were not provided), IM, as prophylaxis, completing the vaccination series.  On an unspecified date (reported as "recently", also reported as "7 years ago" - conflicting information), the patient sought medical attention with her rheumatologist, who ran test and discovered that she never developed antibodies to the vaccine (antibody test negative); therefore, she was advised that she should be revaccinated.  The patient was on remission for 9 year until on approximately 07-DEC-2021 (reported as two or three months ago), when the treating healthcare professional (HCP) discovered during routine monthly rheumatoid arthritis (RA) testing, that the patient had relapsed after not taking methotrexate for 2 years. The patient resumed methotrexate as treatment for the event. No additional information was reported. The outcome of the events was unknown.   The causal relationship between antibody test negative, rheumatoid arthritis and the suspect vaccine was unknown. Upon internal review, rheumatoid arthritis was considered a medically significant event.
Injection site reaction. Large red spot on leg. Hot to the touch. White ring around the red spot.
flushing; palpitations; diaphoresis; This is a spontaneous report from a contactable other HCP reported for self. This 30-year-old female non-pregnant patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via intramuscular on 23Dec2020 at 12:30 at single dose in right arm for COVID-19 immunization. The patient's medical history included asthma, environmental allergies, eczema, anxiety/depression. The patient's concomitant medications included ethinylestradiol, norethisterone acetate (JUNEL FE 24) 1/20, bupropion hydrochloride (WELLBUTRIN XL), fluoxetine hydrochloride (PROZAC), rizatriptan, salbutamol (ALBUTEROL) inhaler, fluticasone propionate (FLONASE), levocetirizine dihydrochloride (XYZAL), betamethasone topical. The patient had none known allergies although possible rash with acetylsalicylic acid (ASPIRIN) in the past- other NSAIDs are fine. The patient experienced flushing/palpitations/diaphoresis about 5 minutes after she received the vaccine, but this resolved quickly and spontaneously.   Information on lot/batch number has been requested.
this client received 1st dose Moderna on 1/21/2021 and then received Pfizer as a second dose 2/11/2021.
diarrhea; fatigue and tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 21Feb2021 09:30 (Lot number: EN6201, Expiration Date: Jun2021) at the age of 69 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (ongoing); "Allergies" (ongoing); "High cholesterol" (ongoing). Concomitant medication(s) included: LOSARTAN taken for blood pressure increased, start date: 2016 (ongoing); SINGULAIR taken for hypersensitivity, start date: 2011 (ongoing); ROSUVASTATIN CALCIUM taken for blood cholesterol increased, start date: 2011 (ongoing). Vaccination history included: Bnt162b2 (Dose: 1, Time: 10:30 AM, Anatomical Site of Injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: EL9263, Expiration Date: May2021), administration date: 31Jan2021, when the patient was 69 years old, for COVID-19 immunisation, reaction(s): "sore arm", "Terrible burning sensation immediately after injection/very sore and burning pain at the time of injection", "Weird taste in mouth", "Fatigue", "Very thirsty", "Mouth was dry", "A little weak", "anxiety", "diarrhea on and off for two weeks". The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; FATIGUE (non-serious), outcome "unknown", described as "fatigue and tiredness".  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. With the second dose, patient did not experience any pain of injection or afterwards. Patient did continue to experience on and off diarrhea. He also experienced more fatigue and tiredness for several days.  No follow-up attempts are possible. No further information is expected.
The IM injection was administered in the side of the arm, between the deltoid and the triceps muscle. SHINGRIX is an IM injection, and should be given in the deltoid muscle to prevent injury to the shoulder/arm. The injection was given and caused immediate pain. The pain continued, and I was unable to lift my arm higher than my shoulder for several days. I have more movement in the arm now, but it is still very painful when I raise it above my shoulder, especially when I reach it to the rear. It is important to note I had no reaction to the vaccine itself, but an injury to the soft tissue related to the anatomical site of injection. No treatment has been sought at this time. I have an appointment with Dr. soon, and plan on discussing/suggesting retraining of his staff that administers vaccines to prevent shoulder injury related to vaccine administration.
Not Feeling Well; Lethargic; Chest Pain; Fever; Couldn't Breathe; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not Feeling Well), LETHARGY (Lethargic), CHEST PAIN (Chest Pain), DYSPNOEA (Couldn't Breathe) and PYREXIA (Fever) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (Not Feeling Well), LETHARGY (Lethargic), CHEST PAIN (Chest Pain), DYSPNOEA (Couldn't Breathe) and PYREXIA (Fever). At the time of the report, MALAISE (Not Feeling Well), LETHARGY (Lethargic), CHEST PAIN (Chest Pain), DYSPNOEA (Couldn't Breathe) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  No treatment information was specified.
Recipient awoke the day after the vaccine with fever, nausea, vomiting, and fatique.
Got sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was not recovered/not resolved.   The reporter considered the sickness to be possibly related to Influenza vaccine.     Additional Information: GSK Receipt Date: 05-JAN-2023 Reporter's comment: This case was reported by the patient via interactive digital media. The patient got Influenza vaccine once, but he/she did not like it, because he/she still got sick at the time of reporting, as usual so he/she did not see a point of it. The reporter thought that the event might had been related to product/device. Additional supportive information: This case was one of the three case reported by the same reporter for different patient.  Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR001600:same reporter US-GSK-US2023AMR001606:same reporter
Patient developed petechial/purpuric rash on both lower extremities, bilateral, symmetrical, mid-calf extending to knees, non-blanching, with mild pruritis. Also had temp 99.5 with chills for 3 days;  Suspected diagnosis was vasculitis; No evidence of coagulopathy; Rash resolved within 1 week and no complications.
This literature marketed report as received from the authors of the published article, refers to a 17 year old patient of unknown gender with reactive airway disease. At the age of 12 months (in approximately 1999) and at the age of 4 years (in approximately 2002), the patient was vaccinated with doses of MMR vaccine (manufacturer unknown) (lot number, expiry date, dose, site and route of administration not reported). On 14-FEB-2015, the patient was seen in an emergency department for evaluation of reactive airway disease. In the waiting room at the same time there were two children who were later confirmed to have measles. The patient began a 5-day course of prednisone (manufacturer unknown) (oral tablet, 50 mg daily); however, symptoms continued, and the patient returned to the emergency department the next day (on 15-FEB-2015) and received methylprednisolone (125 mg, intravenously). The patient had documented receipt of two doses of MMR vaccine (manufacturer unknown), therefore was not administered with intramuscular immune globulin after they had been identified as a person exposed to the two children with measles. On 02-MAR-2015, 16 days after the first emergency department visit, the patient was hospitalized for vomiting and dehydration. The patient was also found to be febrile and to have a confluent popular rash that began on the face and spread to trunk and extremities and had small vesicular oral lesions. Measles was confirmed by laboratory testing (on an unknown day in approximately March 2015), and the patient received supportive treatment with anti-emetics and intravenous fluids. The author concluded that it was not known whether the patient developed immunity to measles in response to the administered doses of MMR vaccine (manufacturer unknown) or whether the patient had an unrecognized immunocompromising condition, but the recent steroid use might have weakened the patient's immune response and rendered the patient susceptible to wild measles strain. The outcome of the measles and vaccination failure was not reported. The author considered vaccination failure and measles to be related to MMR vaccine (manufacturer unknown), since the patient had received 2 doses of MMR vaccine (manufacturer unknown) and did not meet criteria for being severely immunocompromised, but did develop measles after being exposed in the setting of a hospital emergency department to patients with laboratory-confirmed measles. Additional information has been requested.
JANSSEN VACCINE ADMINISTERED PAST ITS TEMPERATURE EXCURSION; POOR QUALITY DRUG ADMINISTERED; OFF LABEL USE; This spontaneous report received from a pharmacist concerned an adult of unspecified 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced janssen vaccine administered past its temperature excursion, poor quality drug administered, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the janssen vaccine administered past its temperature excursion, off label use and poor quality drug administered was not reported. This report was non-serious.
Notified Provider pt seen in ER 5/13/09 pm - 30hr after vaccine gen rash + 102 fever. 5/14/09 still has fever + gen rash. Given antibiotics in ER 5/13/2009.
had fainted on unknown, previous date; GARDASIL 9 injection had hurt at time of GARDASIL 9 administration on unknown, previous date; This spontaneous report as received from  patient's mother regarding a 19-year-old male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, route, anatomical location, lot # and expiration date were not reported) for prophylaxis.  On an unknown date, the patient confirmed had hurt at time of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) administration. Besides, the patient had fainted on an unknown date. The outcome of the events was unknown. The causality assessment between the events and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not reported.    Upon internal review, fainted (PT: syncope) was determined to be medically significant.  This is one of two cases received from the same reporter.; Sender's Comments:  US-009507513-2103USA001105:
Approx 6-8 hours after receiving flu shot pt c/o having a temperature, severe chills, swelling et stiffness to joints and muscles. Pt. also reports rash onset on 10-12-14 to chest, arms and legs. Pt. also reported nausea onset on 10-11-14 et 10-12-14. On 10-14-14 pt reported s/s as improving.
administration of FLUBLOK to a pediatric patient due to allergy to egg (anaphylaxis),with no reported adverse event; Initial information received on 29-Sep-2022 regarding an unsolicited valid non-serious case via pharmacist.  This case involves a 4 years old male patient who had administration of influenza quadrivalent recombinant vaccine [Flublok] to a pediatric patient due to allergy to egg (anaphylaxis), with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 28-Sep-2022, the patient received suspect influenza quadrivalent recombinant vaccine at a dose of 0.5 ml total (lot UJ891AA, expiry date: 14-Jun-2023) via intramuscular route in left deltoid for immunisation.  On 28-Sep-2022 there was administration of flublok to a pediatric patient due to allergy to egg (anaphylaxis), with no reported adverse event (product administered to patient of inappropriate age, latency: same day).  Action taken: Not applicable.  Outcome: Unknown.   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 Regulatory Authority. 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.
Site: Pain at Injection Site-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Dizziness/weakness, confusion-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weakness-Mild, Additional Details: Patient felt weak and lightheaded after vaccine. EMS was dispatched. All vitals were normal. Patient started to recover within 5-10 minutes of calling 911. Suspected panic/anxiety attack to getting vaccine. Called patient 2 hours later and she reported feeling fine overall. Instructed her to call back if any issues occured.
Racing heart beginning 1/2 hr later, lasting 2 hrs?  Headache, mostly in neck and jaw, still present  Dizziness, extreme beginning about an hr later, finishing but still present at times Nausea beginning 1/2 hr later, diminishing still present Fuzzy thinking, still present
3/12/02 mother called HD, pt was irritable last night - pt was and is teething now. Mother gave pt motrin. This afternoon 1pm mother noted that pt has dots on her torso, no c/o pruritis or ?. Rash is 3 hrs in duration
A non-serious spontaneous report of twenty-eight patients received expired FLUMIST was received from a health professional concerning a 17-year-old female. Neither the patient's past medical medical history nor the concomitant medications were reported. The product expired on 20-Feb-2011. The patient received the expired FLUMIST on 02-Mar-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.