chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within 24 hrs at site of injection, (L) deltoid, 4 x 5 cm area of erythema, warmth, tenderness (localized rxn).
NHL - Diffuse Large Cell B diagnosed Jan 2005. As per follow up report I am traditional air national guard that was diagnosed with non hodgekins large cell B diffuse lymphoma while on active duty in Iraq. I received a live of Duty for my cancer meaning it developed in Iraq. My last anthrax and smallpox was given several months before being called up to active duty. Because I was given an LOD I cannot say it was related to the shots.
Patient with history of 3 COVID vaccines who admitted to hospital with COVID detected test.  Provider d/c note:  "82 years old patient with a history of right carotid artery stenosis, seizures, traumatic SDH s/p craniotomies who presented with a syncopal episode. She was found to have mild dehydration with hyponatremia with current covid infection. She is on Depakote 500mg BID delayed release.   Na was 132 which has raised to 135. Depakote levels are 82.8 (goal 50-100). Carotid Dopplers show mild to moderate atherosclerotic changes of the carotid arteries with right more than left with less than 50% stenosis review. 2D echo showed an ejection fraction of 65 to 70%. EEG showed triphasic waves, no seizures, and FIRDA, a nonspecific finding. MRI of the brain without contrast revealed no acute abnormality.   "Syncope" was felt due to a seizure event. Hx of Seizure Subtherapeutic Valproic acid level -Neurology consult, recommending follow up in outpatient setting -Continue Depakote 500mg BID, 250mg daily at 12pm. -EEG abnormal -MRI Brain with no acute abnormality seen, chronic bilateral parietal infarcts. Moderate atrophy   Covid-19 Infection -Incidental finding, remains in isolation.  -Vaccinated x 3. -afebrile, no hypoxia.   HTN- -Continue lisinopril   HLD- -Continue lipitor   Stenosis of right carotid artery-1/17/20 - Right Carotid Endarterectomy (SLD) -Continue ASA/Statin   Vascular dementia without behavioral disturbance-   HOH (hard of hearing)- Requires lip reading or yelling very loud into left ear.    DC 12/18 in stable condition. DC for strengthening as she was weak and debilitated. Prolonged hospital stay to clear COVID-19 quarantine."
PASSING OUT SPELLS; A LOT OF HEALTH PROBLEMS WITH HEART; This spontaneous report received from a patient via social media through company representative concerned of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: Unknown) 1 total dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, according to the reporter "You shot made me have a lot of health problems with my heart after I got the vivid shot. I have been in and out of hospital for the pass few months. I am now on heart meds and having passing out spells" and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from passing out spells, and the outcome of a  lot of health problems with heart was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20211141724-covid-19 vaccine ad26.cov2.s- passing out spells and a  lot of health problems with heart. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
GBS; This is a spontaneous report from a non-contactable consumer via a Pfizer-sponsored program. This consumer reported similar events for six patients. This is the first of six reports. This patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not provided. On unspecified date, the patient developed GBS (Guillain-Barre syndrome) after getting the vaccine. The reporting consumer wanted to know if there were reports of GBS and also wanted to know if she could speak to someone about GBS reports. The reporting consumer mentioned that she knew 6 people who developed GBS after getting the vaccine. Outcome of the event was unknown. This report was assessed by the reporting consumer as non-serious.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101334155 same reporter/drug/event, different patients;US-PFIZER INC-202101334154 same reporter/drug/event, different patients;US-PFIZER INC-202101334158 same reporter/drug/event, different patients;US-PFIZER INC-202101334157 same reporter/drug/event, different patients;US-PFIZER INC-202101334156 same reporter/drug/event, different patients
Pt. presents to facility 05/21/2021 with R hip pain after mechanical fall; underwent surgery and on 06/03/2021 transfered to alternative facility; on 06/22 returns to original facility from secondary with altered mental status. On 06/23/21 pt. passed away due to Acute hypoxic, hypercarbic respiratory failure.
He felt tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (He felt tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (He felt tired). At the time of the report, FATIGUE (He felt tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
1st dose on July2022, did not receive the 2nd; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 62-year-old male patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included engerix B (received 1st dose in July 2022).   On an unknown date, the patient did not receive the 2nd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 31-JAN-2023 Reporter's Comments: The patient who received the first dose of Engerix-B in July 2022.  The patient did not receive the second dose.  The reporter asked if they could administer the Engerix-B second dose or if the patient had to start over with the vaccination. The reporter did not share either patient initials or information about the first Engerix-b dose. The reporter did not consent to follow-up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Engerix B, which led to incomplete course of vaccination.
Onset of chills, aching, "flu-like" symptoms, followed by raised, itchy rash, swelling, redness and pain at injection site.
Fever; Sore throat; A patient received a dose of GARDASIL 9 on 08-AUG-2019 and on 21-JUL-2020; This spontaneous report was received from a physician referring to a 12 years old female patient. Information about pertinent medical history included attention deficit hyperactivity disorder (ADHD). The patient had no drug reactions or allergies. The patient's concomitant therapy included "QUILLICHEW extended-release (ER)".  08-AUG-2019, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (lot # R009615 with expiration date 12-JUL-2020, dose detail was not reported) via intramuscular route for prophylaxis (reported as to prevent human papilloma virus (HPV)).  On 21-JUL-2020, the patient was vaccinated with another dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (lot# 1621926 with expiration date 28-NOV-2021, dose detail was not reported) via intramuscular route for prophylaxis (reported as to prevent HPV) (inappropriate schedule of product administration, onset date was on 07-MAY-2020).   On the same date (reported as starting right after the dose on 21-JUL-2020), the patient developed a sore throat and fever. The peak fever temperature was 102. 5 degree Fahrenheit (F). The patient called the physician for seeking medical attention and she took ibuprofen and acetaminophen (TYLENOL) as treatment for the events. There was no lab diagnostics or studies were performed. At the reporting time, the patient had not recovered from the events of sore throat and fever. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1621926; expirationdate: 28-NOV-2021; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
I started to experience pain in my right ear.  Soon I felt pressure in my ear and sinuses.  I felt like I needed to unplug my ears but swallowing didn?t help.  Additionally, my ears felt warm.  At the same time the tinnitus in my right ear, which had been mild for years, became much more pronounced.  It was debilitating and I had trouble sleeping.  After the second shot, the symptoms continued except I started to feel them in my left ear as well.   Now I also have tinnitus in the left ear, although it isn?t as loud as my right.
General fatigue; Ill felling; tingling in left hand and fingers; Dizzyness; Slight swelling of left wrist; Chills; sweat (no measurable fever)during the night; Swollen, painful lymph node under left arm; Swollen, painful lymph node under left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Apr2021 11:00 (Lot number: EW0161) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Exertional asthma" (unspecified if ongoing), notes: exercise and allergy induced asthma, (mild); "Allergic asthma" (unspecified if ongoing), notes: allergy induced asthma, (mild). There were no concomitant medications. The following information was reported: PARAESTHESIA (non-serious) with onset 23Apr2021 11:10, outcome "unknown", described as "tingling in left hand and fingers"; DIZZINESS (non-serious) with onset 23Apr2021 11:10, outcome "recovered" (23Apr2021 11:40), described as "Dizzyness"; JOINT SWELLING (non-serious) with onset 23Apr2021 11:10, outcome "unknown", described as "Slight swelling of left wrist"; CHILLS (non-serious) with onset 23Apr2021, outcome "unknown", described as "Chills"; NIGHT SWEATS (non-serious) with onset 23Apr2021, outcome "unknown", described as "sweat (no measurable fever)during the night"; FATIGUE (non-serious) with onset 24Apr2021, outcome "unknown", described as "General fatigue"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 23Apr2021, outcome "recovering" and all described as "Swollen, painful lymph node under left arm"; MALAISE (non-serious) with onset 24Apr2021, outcome "unknown", described as "Ill felling".  Additional information: The patient did not have a history of allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccines within four weeks prior to COVID vaccine. Concomitant medication was reported as none. Since the vaccination, the patient had not been tested for COVID-19. The patient underwent lab tests and procedures which included body temperature: no measurable fever on 23Apr2021. It was not reported whether any therapeutic measures were taken as a result of the events. Dizziness was gone after 30 minutes.  No follow-up attempts are possible. No further information is expected.
No adverse effects were reported; Was administered a dose of imporperly stored vaccines; This spontaneous report was received from a Certified Medical Assistant, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided.      On 09-JUL-2019, the patient was vaccinated with improperly stored doses of hepatitis a vaccine, inactivated (VAQTA) lot # S007769 expiration date on 24-JUL-2020 and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live  recombinant human albumin (rHA) (M-M-R II) lot # R031681 expiration date on 01-NOV-2020 (route of vaccination, strength and dose number were not provided) for prophylaxis.  It was stated that, the Hepatitis A Vaccine, Inactivated (VAQTA) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (M-M-R II), were exposed to a temperature excursion of above 47°F (92.3°F) for 13 hours 11 minutes and above 47°F (73°F) for 9 hours. The vaccines were not involved in any previous temperature excursion, and report was made due to a data logger. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA012634: US-009507513-1907USA012634: US-009507513-1907USA012635: US-009507513-1907USA012632:
Eight days after patient received her vaccine, she developed a rash that per her statement, "covered 90% of my body".  She consulted with her primary clinics and then was seen by a dermatologist.  Tests were all negative and she was started on a steroid taper along with Zyrtec and loratadine.  At this time, she is still on these medications and states the rash if still present but much better.
Headache, left hand numbness, injection site inflammation and pain to right elbow, right scapula pain,  diarrhea x2, nausea,
ITCHY FACE, URTICARIA, DIAPHORESIS.  BENADRYL 25MG IM DECADRON 8MG IM
Had 4 seizures 12/29/2001 over several hours, one at home and 3 at the ER. Had low grade fever with 1st seizure. Had been vomiting the days prior to being given her immunizations. Phenobarbital started 12/29/2001 BID PO. Rocephin 500 mg IV a 24 given times 2 starting 12/30/2001. As per doc # 207014.  On 12/29/2001 at 9:35, patient had a low grade fever. Ambulance called for seizure (30 second tonic clonic.  Taken to Hospital.
I received the latest covid 19 vaccine and the next day I discovered I had a blister on my tongue.  It lasted approximately 24 hrs.  I never have had a blister like this before.  I used salt water to gargle to help it go away.
Headache and large, painful lump under left clavicle. Headache relieved with Motrin, did not return. Lump still swollen and painful after 4 days. Previously experienced lump after flu shot in 2012. Previously diagnosed by MD as ganglion cyst.
Red round rash 10 cm x 8 cm to right deltoid no swelling, mildly itchy.
This spontaneous report was received from a registered nurse refers to 3 patients of unknown age and gender. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration and route not reported). No concomitant medications were reported. On an unknown date in the past the patients experienced a mild case of shingles after receiving ZOSTAVAX. The outcome of the reported event was unknown. No information was provided on these 3 patients. This is one of the several reports from the same source. Additional information has been requested.
got the shot and was sick for two hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "recovered", described as "got the shot and was sick for two hours".  Additional information: Investigation Assessment: Not Provided. The reporter adds that she felt fine within a few hours. Her arm did not hurt. She was sick for like 2 and a half hours but then it completely went away.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd vax & devel large areas of redness & swelling which were hot to the touch on the arm following vax;
Headache; Fatigue; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose:2, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose:3, Unknown manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "recovered"; FATIGUE (non-serious), outcome "recovered". Additional information includes physician reported patient got Pfizer COVID-19 booster. She experienced headache and fatigue for 36 hours following booster. She was a female in her late fifties or early sixties. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
covid-19; covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EN6201), in left arm, on 15Mar2021 as dose 2, single (Lot number: EN6203), in right arm and on 01Nov2021 as dose 3 (booster), single (Lot number: FN8028) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Previous history of Asthma. Concomitant medication(s) included: ADVIL [IBUPROFEN], start date: 19Aug2022, stop date: 25Aug2022; FLONASE ALLERGY RELIEF, start date: 15Aug2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: indication=Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.
This is a spontaneous case initially received from the other health professional on 07-Nov-2018, concerning a 63-year-old, adult female patient. The patient was allergic to mold and reacts to PPD. The patient did not receive any concomitant medications. On 05-Nov-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252678 and expiry date: 30-Jun-2019). On an unspecified date in Nov-2018 (started approximately 60 hours), the patient experienced diarrhoea, weakness, nausea, vomiting and fever over 100-degree Fahrenheit. The patient had already lost 4 pounds. The patient did not receive any treatment for the events. On an unspecified date, the patient made an emergency room visit. On an unspecified date in Nov-2018, the patient had recovered from the events diarrhoea (stopped at 6 am), nausea, vomiting (last time at 4:30 am) and fever. The patient had not recovered from the event weakness. The outcome of the event weight decreased was not reported. The reporter assessed the case as non-serious.
Initial side effects (24 hours) soreness in upper arm. Within 36 hours I started getting extreme light headed. Within 3 days I started having pins and needle sensation in my right arm, from my shoulder to my finger, mainly my pinky and ring finger. I progressed to my left arm and right leg.  I've had back pain since then but not sure if it's related. The pins an needles I feel every now and then but not as bad. The light headedness has not gone away, I can't shake it.  I've seen my Dr, he put me on an anxiety medication.  My blood work came out good. I started the anxiety meds and started seeing a Therapist , but I don't really see a difference, it's nice to see someone but not getting better. I'm coming off the anxiety med because a side effect is light headedness and that's not helping me much.  I have not got the second dose and do not plan on getting it.