chrisvoncsefalvay/vaers-outcomes huggingface dataset:
have got them after the 2 shots/Suspected Vaccination Failure; have got them; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: have got them after the 2 shots/Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: have got them). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 23-MAR-2023 The case  was received from the patient via interactive digital media. The patient stated that sad crying face was not the emoji he/she would use.  The patient stated that it was far far worse than that. The patient had got them even after the 2 shots they gave you for prevention. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Developed tinnitus in left ear.  No hearing loss noted; no history of ear issues.  MRI and CT scan resulted in normal brain activity.  No other known causes for tinnitus per doctors.  Likely a result of the Covid vaccine.
patient was on list provided by facility to receive a flu shot - he received - and then an advocate walked up and said she had told someone he had already received the flu shot recently
had an anaphylactic reaction to the Pfizer shot and very short of breath; very short of breath; tongue is swollen; throat is swollen shut like patient can barely swallow; throat is swollen shut like patient can barely swallow; patient can barely swallow; Dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Lot number: FL3209) 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: ANAPHYLACTIC REACTION (hospitalization, medically significant) with onset 07Jan2022, outcome "not recovered", described as "had an anaphylactic reaction to the Pfizer shot and very short of breath"; DYSPNOEA (hospitalization, medically significant) with onset 07Jan2022, outcome "not recovered", described as "very short of breath"; SWOLLEN TONGUE (hospitalization, medically significant) with onset 07Jan2022, outcome "not recovered", described as "tongue is swollen"; PHARYNGEAL SWELLING (hospitalization, medically significant), THROAT TIGHTNESS (hospitalization, medically significant) all with onset 07Jan2022, outcome "not recovered" and all described as "throat is swollen shut like patient can barely swallow"; DYSPHAGIA (hospitalization, medically significant) with onset 07Jan2022, outcome "not recovered", described as "patient can barely swallow"; DIZZINESS (hospitalization, medically significant) with onset 07Jan2022, outcome "not recovered", described as "Dizzy". Therapeutic measures were taken as a result of anaphylactic reaction, dyspnoea, swollen tongue, pharyngeal swelling, throat tightness, dysphagia, dizziness. Patient was given diphenhydramine (BENADRYL), triamcinolone (DERMAZONE), Epinephrine and sent to the hospital. Patient was released after 5 hours. Patient was sent home with mild dose of diphenhydramine (BENADRYL) and Albuterol.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On 04-AUG-2015 the patient was vaccinated with a dose of improperly stored PROQUAD (lot # K018144, expiration date 10-APR-2016, dose, dose# and route not reported). There was bi adverse events reported. This sis one of several reports received from the same reporter. Additional information has been requested.
Received Moderna vaccines on 4/2/21, 5/11/21 COVID-19 positive by PCR on  1/9/22 admit to hospital 1/9 for suicidal ideation, incidental COVID positive on admission, mild symptoms
This case was reported by a other health professional via sales rep and described the occurrence of fever in a male patient who received SHINGRIX for prophylaxis. On 9th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, myalgia, injection site pain and activities of daily living impaired. On an unknown date, the outcome of the fever, myalgia, injection site pain and activities of daily living impaired were recovered/resolved. It was unknown if the reporter considered the fever, myalgia, injection site pain and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had fever, Myalgia, pain at the injection site and was not able to work. They did complete VAERS report. All symptoms were resolved. The reporter had several patients develop side effects from the vaccine. Clarification has been raised for creation of master case for several patients.
Patient began with chest pain onset today while sitting in chair at home. Patient called ems and was found to have HR of 193. Patient did 2 vagal maneuvers and hr dropped to 150. Patient reports decreased chest pain, denies cough or n/v. Patient on arrival has an initial HR of 132 and a BP 106/69.  Temp 36.6 degrees Celsius.  HR decreased to 100 with no intervention.  500mL of fluids given.  Diltiazem was not given as HR decreased to 100 and BP was 98/62.  Patient reports that she had her COVID19 vaccine yesterday followed by some arm pain and aches in her legs. Patient does have a history of Afib and is on diltiazem at home.  Dx with Afib with RVR.  Patient will be admitted to the hospital.  Patient converted to NSR on her own.
Within 12 hours of immunizations, both eyes rolled laterally - each towards respective ear. Lasted seconds. No fever. No other symptoms.
A non-serious spontaneous report of inadvertently administered expired FLUMIST was received from a health professional concerning a five-year-old male. Neither medical history nor concomitant medication was reported for this patient. The product expired n 02-Dec-2010. On 03-Dec-2010, the patient received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Developed a rash on my face two days after receiving vaccine; Recent biopsy revealed a form of atopic dermatitis; eczema; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 29Nov2021 as dose 3 (booster), single (Lot number: FG3527), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PRAVASTATIN. Vaccination history included: BNT162b2 (prev dose product: COVID 19, prev dose brand: Pfizer, prev dose lot number: EN6198 , prev dose number: 2, prev dose vaccine location: Left arm, I also had an adverse event with 2nd dose that I previously reported - gout- occurred the day after vaccine), administration date: 03Mar2021, for Covid-19 immunization, reaction(s): "gout"; BNT162b2 (prev dose product: COVID 19, prev dose brand: Pfizer, prev dose lot number: EL9269, prev dose number: 1, prev dose vaccine location: Left arm), administration date: 02Feb2021, for Covid-19 immunization. The following information was reported: RASH (medically significant) with onset 01Dec2021, outcome "not recovered", described as "Developed a rash on my face two days after receiving vaccine"; DERMATITIS ATOPIC (medically significant) with onset 01Dec2021, outcome "not recovered", described as "Recent biopsy revealed a form of atopic dermatitis"; ECZEMA (medically significant) with onset 01Dec2021, outcome "not recovered". The events "developed a rash on my face two days after receiving vaccine", "recent biopsy revealed a form of atopic dermatitis" and "eczema" required physician office visit. The patient underwent the following laboratory tests and procedures: Biopsy: atopic dermatitis/eczema, notes: Recent biopsy revealed a form of atopic dermatitis/eczema; SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of rash, dermatitis atopic, eczema.  Clinical course: No covid prior vaccination. Covid tested post vaccination. No other vaccine in four weeks. Other medications in two weeks: Pravistatin. Adverse event: Patient developed a rash on his face two days after receiving vaccine. Multiple visits to dermatologist and treatments with creams, ointments and steroids did not eliminate. Recent biopsy revealed a form of atopic dermatitis/eczema which he has to begin treatment with injectable. This was the first occurrence of any type of this diagnosis at age 62. (Patient also had an adverse event with 2nd dose that he previously reported - gout- occurred the day after vaccine). AE treatment: topical creams, steroid ointments; oral steroids.
Late on the 7th day after the vaccine (Sunday, Jan 17) my arm a bit below the vaccine site started to itch.  I get skin itching sometimes and put  prescription Ultravate lotion on it.  The next morning (Jan 18) it itched more and the Ultravate did not to relieve it, so I put hydrocortisone cream on it and that made the itching stop.  The area that itched was about the size of a golf ball and was red. I put hydrocortisone cream on Jan 19 once in the morning and at night.  Today, Jan 20 when I woke up the area is red and about 4" long and 3" across, mostly below the injection site. It itches some. I don't have a primary care physician.
Arm was itchy  the second day after vaccination as nd still is.  A bruise showed up on April 4, 2021.  On April 6 , 2021 The arm started turning red about three inches below the vaccine spot
thrombotic stroke -necessitating hospitalization; and craniotomy; required mechanical ventilator for 2 days. Patient now extubated, breathing on her own. Patient remains hospitalized with marked deficits (aphasic)
FEVER AND VOMITING SAME DAY FOLLOWING 2ND AND 3RD DOSES
Could not breathe for 2 hours after 12 hours of getting the vaccine. Extreme tingling in bones. Especially both wrists.
This spontaneous report was received from a medical assistant refers to a patient of unknown age. On an unknown date, the patient was vaccinated with improperly stored doses of VARIVAX, lot # M000996, expiry date 07-JAN-2018. No adverse reactions were reported. Additional information has been requested.
administered Engerix Recalled  lot; administered Engerix Recalled  lot; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B pediatric) (batch number CP23D, expiry date December 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric 10 mcg .5 ml and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The medical assistant reported that, the patient administered Engerix B recalled Lot number back in June 2021 through July 2021, which led to recalled drug administered and drug dispensing error. The medical assistant unable to provide patients details. The reporter did not consent to follow up. This case was 1 of 70 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021223559:Same reporter
Swelling of arm and shoulder in the days following with some pain. Pain subsided within a few days but a week after the shot have a golf ball sized, hard spot at the site of injection that is itchy.
Moderna COVID-19 Vaccine EUA Body aches, chills, fever 12 hours after vaccine. Fever went up to 102 by hour 14. Tylenol was taken at hour 14. By hour 21, fever was gone.
The vial was initially stored in the refrigerator on 02-MAR-2023 and administered to patient on 27-APR-2023; No adverse event; Accidentally administered dose of Moderna COVID-19 Vaccine Bivalent after more than 30 days stored in the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Accidentally administered dose of Moderna COVID-19 Vaccine Bivalent after more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-MAR-2023 and administered to patient on 27-APR-2023) and NO ADVERSE EVENT (No adverse event) in a 67-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Hyperlipidemia.    On 27-Apr-2023, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Accidentally administered dose of Moderna COVID-19 Vaccine Bivalent after more than 30 days stored in the fridge). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-MAR-2023 and administered to patient on 27-APR-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Accidentally administered dose of Moderna COVID-19 Vaccine Bivalent after more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-MAR-2023 and administered to patient on 27-APR-2023) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Accidentally administered dose of Moderna COVID-19 Vaccine Bivalent after more than 30 days stored in the fridge) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-MAR-2023 and administered to patient on 27-APR-2023).    It was unknown patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications were provided. The dosage text was reported as unknown. The vial size was 2.5 ml. The vial was initially stored in the refrigerator on 02-Mar-2023. The vial did not undergo any temperature excursions. No Adverse events were reported.  No treatment medication was provided. This case was reported for patient number 3.
Several minor adverse reactions to first dose of Shingrix vaccine: Persistent redness and soreness at injection site lasting five days. Persistent muscle a joint soreness for several. Minor fever (99.6 deg.) lasting two days. Headache for one day.
Approximately 2 min after receiving Hep A vaccine and fingerstick for hemoglobin pt was sitting in the chair and fell from the chair onto the floor pt. began arching and stiffening for only seconds. Pt was assessed by in house pediatrician and sent to local emergency room for assessment.
patient received 1st dose at 10:30 am and within 1 to 2 minutes by 10:32 am  patient fainted/ experienced syncope.  He came back to within the following minute and was able to speak to us.  He was given water and said he then felt better. 911 was called immediately upon snycope and the paramedics responded about 6 minutes later.  Paramedics observed that his blood pressure was 126/78 and heart rate was 60.  temp was 97.2 degrees F.   Paramedics looked him over for signs of allergic rxn of which he had no rash or itching.   He was able to speak and walk normally by then and refused medical treatment at the hospital.
In the afternoon of April 7, 2022, I had extreme anxiety, like a panic, my heart fluttered, I could not sleep and have had varying success of sleeping since. I feel like there is something wrong. I went to the doctor, she did blood work, she said I think you're fine, I think it is mental. I am still experiencing those same symptoms, severe anxiety and body aches.
Patient came in with redness, red bumps on extremities, face, neck, chest and back. The smallpox vaccine also moved to the opposite arm.
Symptoms:    Fever of 103F for four days, onset one day after vaccination.    Nausea, listlesness, generally ill and bedridden
Pt and his mother went to their car after vaccination.  After about 5 minutes, mom beeped the horn, so myself and another nurse, RN., ran to the car.  Once arriving there, pt was in the passenger seat, appearing pale, and mom said he was not feeling well.  Reclined the seat fully had had him lay back.  VSS.  Never lost consciousness.  Pt had not eaten nor drunk anything before his appt at 12:15 pm.  Gave him some water and crackers with peanut butter.  Within 5 minutes, pt's color returned and he stated he was feeling better.  Mom was going to take him to get some lunch in a drive-thru.  No further issues at this time.
Eye lid swelling / can?t open eye all the way. Left eye. Received Botox injection last week and dermatologist said that the Botox and vaccine could be reacting negatively
hard to swallow; migraine on left side of my forehead; felt tingly in finger; voice was horse; itchy arm; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (felt tingly in finger), MIGRAINE (migraine on left side of my forehead), DYSPHAGIA (hard to swallow), DYSPHONIA (voice was horse) and PRURITUS (itchy arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Amoxicillin and Clindamycin).    On 16-Apr-2021 at 1:50 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced PARAESTHESIA (felt tingly in finger), DYSPHONIA (voice was horse) and PRURITUS (itchy arm). On 28-Apr-2021 at 5:00 PM, the patient experienced MIGRAINE (migraine on left side of my forehead). On 28-Apr-2021 at 7:00 PM, the patient experienced DYSPHAGIA (hard to swallow). On 28-Apr-2021, PARAESTHESIA (felt tingly in finger) and PRURITUS (itchy arm) had resolved. On 28-Apr-2021 at 6:00 PM, MIGRAINE (migraine on left side of my forehead) had resolved. On 28-Apr-2021 at 8:00 PM, DYSPHAGIA (hard to swallow) had resolved. At the time of the report, DYSPHONIA (voice was horse) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications information was reported. No treatment medications were provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
About 24 hours after vaccine.  Temperature 101 degrees, hives, scattered all over body.  Returned to clinic 08/28, 08/29 with temperature to 104 degrees per mom, hives continued.  Told to follow up if fever and rash present.
pt exp sleeply, felt lighheaded-drunk feeling, made inappropriate remarks; halucinated during sleep-felt brain was awake but couldn't function body; bad dreams;
Would like to report some crazy side effects to the Tdap I recieved on 9/30/21: Within 2 hours after receiving: 1. Uncontrollable crying/sobbing that lasted for hours 2. Hot face and neck- no fever  3. Majorly inflamed sinuses causeing extreme pain of all teeth and jaw 4. Red spotting on face and neck 5. Blurred/foggy vision 6. Severe weakness in both lower legs. 7. Chest pain/rapid heart beat. I did call nurse line when side effects were getting to be too much and I was taken to ER by Ambulance. I'm am still coping with the vision and weakness of lower legs issues. After questioning about if I had a reaction from the one I recieved 11 yrs ago, I reviewed my file from that date and there are a few visits for care around leg issues and heart monitoring.
Woke on day 2 after KINRIX (DTaP/IPV) given with 9 cm length X 7 cm width area of inflammation/erythema, slight central swelling and warmth to touch 2.5 cm central induration. No bruising or restriction of movement, pruritic but only 2 on 0-10 scale of pain.
19MAY mom reports pt broke out in rash then ankles & wrists became purple in color;c/o pain in feet-was taken to ER & seen by MD;was given DPH;discomfort of feet;top feet red in color;
Initial information received on 07-Jan-2019 regarding an unsolicited valid non-serious case received from other health professional. This case involves a two years old patient who administered a 0.5 ml dose of Influenza Quadrival A-B Vaccine instead of a 0.25 ml. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to Overdose. It was not reported that the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. List of documents held by sender: none.
Headache, fatigue, muscle aches, chills, arm soreness and increase warmth at injection site.
States that he experienced a sore swollen throat approx forty-five minutes after receiving the tetanus injection on 8/19/05. He took Tylenol PM which relieved his symptoms. His symptoms lasted from 8/19/05 through 8/22/05.
Pain (Soreness) at injection site, fatigue (weakness), headache, muscle pain, joint pain (flu like) for approx. 24 hours.  Unusual for me as I have already had all (6) COVID) vaccines/boosters plus a course of Paxlovid with little to no such symptoms. I.e., I was surprised by the intensity of these symptoms. Still feeling some fatigue after 36 hours although other symptoms appear to have ended. I was especially surprised by sore calf muscles which were very sensitive as well as elbow joint pain which was rare if not unknown to me. Since the symptoms abated the following day I did not feel the need to visit a doctor. I did take some extra strength Acetaminaphen which helped.