chrisvoncsefalvay/vaers-outcomes huggingface dataset:
zoster related hearing loss; zoster related hearing loss; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant therapies was provided. On an unknown date in 2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) as prescribed and/or administered by a healthcare provider at a hospital for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a physician at a vision center for zoster related hearing loss. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), hte pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the events was considered to be not recovered. The reporter considered the events of zoster related hearing loss to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of hearing loss was determined to be medically significant.
This spontaneous report as received from a physician (patient's parent) via a company representative refers to a male patient of unknown age (also reported as middle school aged at the time of the report). It was reported that on an unknown date, as young child the patient had received the requisite two VARIVAX injections (subcutaneously, dose and lot # not reported) and then on an unknown date (also reported as very recently), contracted chickenpox. The patient did not seek medical attention. The outcome of the event was unknown. Causality assessment was not provided. Additional information has been requested.
About 2 weeks after vaccine administered, the patient developed severe joint pain and myalgias.  Most affected joints were knees, elbows and hands.  Testing has not revealed a cause of the joint pain.  Using aleve, the pain is slowly improving.
This is a spontaneous report from a contactable physician via a Pfizer Sales representative. This physician reported similar events for two patients. This is the first of two reports. This over 60 year old patient (race and gender unknown) received PREVNAR 13 on an unknown date. Relevant medical history and concomitant medication were unknown. It was reported that the patient experienced really bad rashes and cellulitis on an unknown date. Relevant laboratory data and therapeutic measures were unknown. Outcome was unknown at the time of report.
We had no sign at all of anything being wrong with patient. Until the night of Oct 4th. When she just didn't seem to feel well. We put her to bed around 130 a.m. and woke up just a few hours later to find her not breathing and cold in her bed. Upon completion of her autopsy it was found that she had pneumonia and infection of the brain and spine.
Developed a "scratchy throat approximately 20 minutes post vaccination. Symptoms worsened and she developed shortness of breath. Required evaluation and treatment in the Emergency Department. Received Benadryl, dexamethaxone, famotidine and solumedrol. Second COVID vaccine, no reaction with the first vaccine. ED provider notes below: This patient presented due to concern for allergic reaction to COVID-19 vaccine and was seen by myself immediately upon arrival.  When in triage the triage nurse noted her oxygen saturation was 81% so she was placed on 2 L nasal cannula and brought directly back to her room.  When placed in the room she was hooked up to the monitor and her oxygen saturation was 100% and I took her off of the nasal cannula and her oxygen saturation remained in the upper 90s.  She had no stridor and respirations were nonlabored.  She was speaking without difficulty and had no vocal changes.  She did not appear to be in any acute distress.  Her posterior oropharynx was widely patent and she had no uvula or tongue swelling or lip swelling.  She did have some blotchiness to the upper chest area but no hives.  Abdomen was soft and nontender.  Pulse was regular.  Blood pressure was stable.  She was nontoxic in appearance.  An IV was established and the patient was given Decadron and Benadryl for initial treatment.
Within one hour: irritability, crying and fatigue. These symptoms are still present daily.   After invasive medical testing it was discovered that she now has inflammation throughout the body and specifically in digestive system.  Slower thinking and comprehension were noted. Stomach pain almost daily.
After 3-4 hours, patient experienced pain in left arm at injection site that increased throughout the day and into the evening. The arm became swollen in the evening hours. The patient experienced fatigue during evening hours. The next morning, 24 hours after receiving vaccine, patient experienced fatigue, pain and swelling in arm at injection site and patient ran a low grade fever that lasted until 4 pm that day.
pt recv vax 30SEP97 & a few hr p/vax rash started again & was itchy;
Hives; Booster; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date 03Dec2021 (Lot number: FG3527) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Psoriasis" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EM9810), administration date: 04Feb2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3248), administration date: 12Jan2021, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 03Dec2021, outcome "unknown", described as "Booster"; URTICARIA (non-serious) with onset 24Dec2021, outcome "not recovered", described as "Hives". Therapeutic measures were not taken as a result of urticaria.  Additional Information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. No COVID-19 tested post vaccination. No known allergies.  No follow-up attempts are possible. No further information is expected.
the only time i've the flu, is after the shot. nope never again with no reported adverse event; Initial information received on 30-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer.  This case involves an unknown age and unknown gender patient who was diagnosed with the only time i've the flu, is after the shot. nope never again with no reported adverse event while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer (strength, dose, frequency, formulation, route, batch number, expiry date: unknown) via unknown route in unknown administration site.  On an unknown date the patient diagnosed with non-serious the only time i've the flu, is after the shot. nope never again with no reported adverse event (vaccination failure) (unknown latency) following the administration of influenza vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown
Right upper arm swelling, itching, pain, edema skin from deltoid to elbow within 4 hours.  By next am after Prednisone edema upper arm less.  Bruised appearance to upper forearm.  Patient on Coumadin.  Did ice arm and apply pressure.  Not clear hematoma as more serious swelling.
Hand tremors, wrist curling, waking up with high pitch screams, Spacey, stopped cooing, stopped laughing and smiley, gasping or air when sleeping, body quivering, uncontrolled twitching, shoulder and neck stiffness, listlessness
Redness at injection site, turning into rash on arm, for several days. Dr gave a steroid shot and steroid cream and she is taking benadryl.
Numbness in left arm from elbow to 4th and 5th digits.  The numbness largely went away but persists to this day with the sides of the ring finger and pinky finger remaining numb.  I fear at this point is is permanently damaged nerves
Patient called stating severe pain in her arm where vaccine was given. I told her she should go to urgent care. The patient later called me to tell me she was returning to urgent care for additional antibiotics.
Dose 1 and dose 2 Moderna, Dose 3 Pfizer; Dose 1 and dose 2 Moderna, Dose 3 Pfizer; Booster; Hives and itching and its started on my hands and my cheek;; Hives and itching and its started on my hands and my cheek; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Nov2021 09:00 (Batch/Lot number: unknown) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Verbatim: Blood pressure high. Concomitant medication(s) included: CHLORTHALIDONE taken for hypertension; AMLODIPINE; ASPIRIN (E.C.); PREMARIN; VITAMIN D 2000; AMPHETAMINE; DEXTROAMPHETAMINE [DEXAMFETAMINE]. Vaccination history included: Moderna covid-19 vaccine (Dose 1), for immunization; Moderna covid-19 vaccine (Dose 2). The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 11Nov2021, outcome "unknown" and all described as "Dose 1 and dose 2 Moderna, Dose 3 Pfizer"; IMMUNISATION (medically significant) with onset Nov2021, outcome "unknown", described as "Booster"; URTICARIA (medically significant) with onset Nov2021, outcome "unknown", described as "Hives and itching and its started on my hands and my cheek;"; PRURITUS (medically significant) with onset Nov2021, outcome "unknown", described as "Hives and itching and its started on my hands and my cheek". Therapeutic measures were taken as a result of urticaria, pruritus including diphenhydramine (BENADRYL).  Course of the event. "I started getting the hives and itching and its started on my hands and my cheek and I was very uncomfortable for about three days and I started calling, I called my doctor and she said that it was probably a reaction to the shot and she told me take Anti- histamine around the clock for 2 weeks and not to stop"   The lot number for bnt162b2 was not provided and will be requested during follow up.
I originally had injection site pain immediately after vaccine, which went away after a few days. However, this week i began to feel injection site pain again that was dull, but still strange to me. I?m not sure if this is anything of concern, but couldn?t find instances online of this happening to anyone else.
The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 1-year-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the vaccines hepatitis a vaccine, inactivated(VAQTA) (lot # S019435 with expiration date 23-AUG-2020, lot # S026003 with expiration date 17-OCT-2020, and lot # S032056 with expiration date 09-NOV-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) 25/0.5 dosage form at a dose of 0.5 ml (route not provided) for prophylaxis. No adverse events were reported.  This is one of several cases from the same reporter.  combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S019435; expirationdate: 23-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004521: US-009507513-2005USA004522: US-009507513-2005USA004523: US-009507513-2005USA004524: US-009507513-2005USA004525: US-009507513-2005USA004526: US-009507513-2005USA004527: US-009507513-2005USA004528: US-009507513-2005USA004529: US-009507513-2005USA004530: US-009507513-2005USA004531: US-009507513-2005USA004532: US-009507513-2005USA004533: US-009507513-2005USA004534: US-009507513-2005USA004535:
On 18Apr04 member was administered smallpox vaccine. On 23Apr04, member started experiencing pain in legs, progressing throughout body. Member reported to ER on 27Apr04 and was released same day.
I was feeling run down, that led to terrible fatigue, coughing, sore throat, my ears hurt, it felt like an upper respiratory infection. I took a home COVID-19 test that came back negative, I decided to go get tested to find out what I had. I was very surprised when the nurse came in to tell me I was positive for COVID-19. They did not have the medication to give me at that time. My husband went out to get me over the counter medications to take to help me to fight the virus. It took me five days to get over the symptoms, the fatigue lasted longer than I would have liked.
Within several hours extream pain in ankles - over several days pain all over increased - had to use a walker - med helped slightly got better Within one hour extream pain in ankles - every thing repeated still hurting/using walker
Systemic: Fainting / Unresponsive-Mild, Additional Details: Pt reported to clinic for 18m - 4y COVID vaccine. Vaccine was within expiration and BUD. This is pt's second dose. Pt was given injection by LPN and within 30 seconds patient became unconscious. Pt was unconscious for less than 30 seconds. EMS activated immediately. Pt placed on bed and sat up. Pt awake at time of provider entry into room. Vital signs assessed and pt sitting on exam table while EMS is arriving. Pt was awake and alert when EMS arrived. EMS recommended f/u at local emergency room.
Pt was administered Varivax right arm on 3/13/07 and had an allergic reaction. Came back into our office on 3/16/07 patient had swelling and red all over, arm warm to touch. Benadryl given PO.
she tested positive for COVID; she tested positive for COVID; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 02Mar2021 as DOSE 1, SINGLE (lot number: EL9262), on 23Mar2021 as DOSE 2, SINGLE (lot number: EL9262) and on 08Jan2022 as DOSE 3 (BOOSTER), SINGLE (lot number: 330308D) at the age of 64 years, for COVID-19 immunization. The patient's relevant medical history included: "Periventricular contractions benign" (unspecified if ongoing); "heart palpitations" (unspecified if ongoing); "panic attacks" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "Antidepressant" (unspecified if ongoing). Concomitant medications included: TOPRAL [SULTOPRIDE HYDROCHLORIDE] taken for heart palpitations, periventricular contractions benign; PAXIL [PIROXICAM] taken for panic attacks, anxiety, and as antidepressant. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "she tested positive for COVID." The patient underwent the following laboratory tests and procedures: Covid-19 test (SARS-CoV-2 test): (Oct2022) Positive, notes: She called her doctor on Thursday and reported she tested positive for COVID. Therapeutic measures were taken as a result of Vaccination failure, Covid-19. It was reported that the patient had 1st 2 vaccines and 2 boosters of COVID-19 Vaccine by Pfizer. Caller was diagnosed with COVID prior to getting her next booster dose. The vaccine doses were off.
This spontaneous case reported by a consumer, describes the occurrence of pruritic rash (very itchy rash) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 007M2012 and 010A21A) for COVID-19 immunization. No medical history reported. On Jan 28, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Feb 26, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced pruritic rash (very itchy rash). At the time of the report, pruritic rash (very itchy rash) outcome: unknown. Reportedly, patient had no other adverse events; and not even rash after the second dose. Concomitant medication and treatment information not reported.
About 5 to 10 minutes after receiving vaccine (during observation period), patient became dizzy, lightheaded and his skin was very pale and clammy. His hands were red and warm to the touch.  About 3 to 5 minutes after symptoms started, he passed out for about 10 seconds, but came to on his own. EMS was called and he was checked- out by paramedics, his blood pressure and blood sugar were all within normal range. They observed him for 5 to 10 minutes after which he signed a "refusal" to be transported to ER. He stated he was feeling better and would continue to self-monitor at home with his girlfriend.
First shot over a year ago; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose over a year ago at the time of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The case was self reported by the patient. The age at vaccination was not applicable for this report. The reporter reported that he/she received the first Shingrix shot over a year ago, should he/she get the second, which led to incomplete course of vaccination. The reporter reported for patients 50 years or older, was there a time that was preferred in the 2 to 6 month time frame to get second dose of Shingrix. Follow up would not be possible as contact details were not provided.
patient reports body aches and chill on 1/20/2021 that started at 5:30 am
Chest heaviness, difficulty breathing, joint pain/ache, disseminated skin sensitivity, dizziness, lightheadedness
Four hours after the first immunization had malaise, mild chills alternating with hot sweats. Treatment: 500 mg Tylenol x1 dose.   After second immunization experienced severe chills with uncontrollable shivering/shaking and then profuse sweating and hot sweats for approximately 4 hours. Nausea followed the next morning along with an approximately 36-hour headache. Rested x2 days in bed. Treatment: Ibuprofen 800 mg alternating with acetaminophen 500 mg without relief x multiple doses.
SWELLING FOREARM; RED AND BLUE ARM; SWELLING ELBOW; ITCHY ARM; INFLAMMATION IN ARM; BRUISED ARM; ARM SWELLING UP AROUND RIGHT SHOULDER WHERE GOT THE SHOT; This spontaneous report received from a consumer concerned a 71 year old male. 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: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced swelling forearm. On APR-2021, the subject experienced red and blue arm. On APR-2021, the subject experienced swelling elbow. On APR-2021, the subject experienced itchy arm. On APR-2021, the subject experienced inflammation in arm. On APR-2021, the subject experienced bruised arm. On APR-2021, the subject experienced arm swelling up around right shoulder where got the shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the swelling forearm, red and blue arm, swelling elbow, itchy arm, inflammation in arm, bruised arm and arm swelling up around right shoulder where got the shot was not reported. This report was non-serious.
Fever after vaccination. 2 days later. Swelling started. On 5/9/12 at 12:20 PM severe swelling (warm) at the injection site and upper left arm.
Swelling, redness 10 x 10 cm in area around injection site within 1 hr injection.
This case was reported by a pharmacist via call center representative and described the occurrence of optic neuritis in a adult female patient who received SHINGRIX (batch number XC534, expiry date 4th July 2020) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced optic neuritis (serious criteria GSK medically significant). On an unknown date, the outcome of the optic neuritis was recovered/resolved. It was unknown if the reporter considered the optic neuritis to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. In 2018, the patient developed optic neuritis. The healthcare professional could not provide any further information about the patient. The optic neuritis was confirmed by the Clinic. Follow up could be done with health care professional for further details.
From initial info received on 6/16/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 42 year old female pt received a dose of TD ADS ADULT, lot U1022AA, in the left deltoid on 5/17/04. The route of administration was not reported. Three days later, on 5/20/04, the p'ts upper arm about her elbow became swollen, red, hot, hard and began itching. A physician in the hospital, where the pt works, evaluated the symptoms and prescribed Motrin, Benadryl and ice. Reportedly, the symptoms resolved after 1 week.