chrisvoncsefalvay/vaers-outcomes huggingface dataset:
stroke in his left eye in the vascular leading to his left retina; This spontaneous case was reported by a consumer and describes the occurrence of RETINAL VASCULAR DISORDER (stroke in his left eye in the vascular leading to his left retina) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced RETINAL VASCULAR DISORDER (stroke in his left eye in the vascular leading to his left retina) (seriousness criteria hospitalization and medically significant). At the time of the report, RETINAL VASCULAR DISORDER (stroke in his left eye in the vascular leading to his left retina) outcome was unknown.            Laboratory test performed and result was negative and heart is normal. No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.  Company Comment: This case concerns a 65-year-old, male patient with no relevant medical history reported, who experienced the unexpected and serious event of retinal vascular disorder. The event occurred approximately 6 months after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine) was administered. The rechallenge was not applicable since event happened after the second dose. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a 65-year-old, male patient with no relevant medical history reported, who experienced the unexpected and serious event of retinal vascular disorder. The event occurred approximately 6 months after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine) was administered. The rechallenge was not applicable since event happened after the second dose. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
Acute tendinitis started in November '22 followed by torn achilles tendon in Feb '23.  Surgery to repair tendon on March 1, followed by SHINGLES outbreak at surgery site on March 18.  I had been complexed Shingrix VAX regime on Jan 4, '21.
The patient was given a vaccine after being drawn up 18 hours prior. Which would be consider expired
headache; chills; nausea; A spontaneous report was received from a consumer concerning a female patient who was participating in the mRNA-1273 Emergency Use Program and who experienced headache, chills and nausea.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 on 31-Dec-2020 intramuscularly in the for prophylaxis of COVID-19 infection.   Patient received the Moderna vaccine on 31-Dec-2020 at approximately 0815.  On 01-Jan-2021, she reported that she began to experience headache, chills and nausea.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events, headache, chills and nausea, was not provided.  The outcome of the events, headache, chills and nausea, were considered as unknown.; Reporter'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.
Severe progression of exercise intolerance starting on 10/29/21  which progressed to a severe  event not be able to walk up stairs without severe fatigue and a rapid heartbeat.  Diagnosed with persistent Afib.
Information has been received from a physician concerning a 44 year old male pt who on approximately 18Apr2003, was vaccinated with a dose of varicella virus vaccine live. On 02May2003, the pt presented to the office with 7 disseminated vesicular lesions on the trunk and face. Unspecified medical attention was sought. There was no product quality complaint reported. MD provided no further information.
I started out with chills, then I had lots of sweating and sore throat.  I did a COVID-19 rapid test and it was positive on 03/26/2023.  I still have sinus drainage and still have a sore throat today.  I received treatment of Paxlovid which I started taking on 03/27/2023 and this was prescribed by my doctor.
Information was received from a lawyer regarding a case in litigation involving a male patient, age and medical history not provided. In 2014 the patient was inoculated with ZOSTAVAX vaccine at a drug store for routine adult health maintenance and the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2016 the patient was treated by a physician at a medical clinic for onset of a vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages. Additional information has been requested.
Noticed on informative paper printed and given to me GSK is mentioned in bottom corner in regards to this vaccination. A different Mfr. was given to me by a staff member. Sunday morning following vaccine on Friday afternoon, a bump rather large on my nose, dirty looking particle on biopsy in appearance, discharge on urinating. Still have some signs of menstruation and some lower abdominal cramps. Also, soreness in area where injection was given - took off band aid this day. No signs of more bleeding, just a point from previous entry that was not covered by the cotton part of the band aid. It was covered by the sticky part near the box of cotton. Much aches and pains all over, especially in back, legs, and ankles. The manufacturer that was mentioned as the provider for this vaccine is Sanofi Pasteur. However, on the information paper given to me with info about the vaccine has the (GSK) mentioned at the bottom of page. In previous forms this is a manufacturer - GlaxoSmithKline. On the info paper, only the symbol with initials are legible. The print after it is too foggy to comprehend. Today's food intake is: Coffee - regular, caffeinated, instant in the AM and at lunchtime with 3 small tsp. sugar and some whole milk. Breakfast for me and dog was scrambled eggs (4) between the 2 of us. A snack was butter cookies. Another snack is island pineapple yellow jello. Saturday night was a bowl of chili and some saltine crackers. With PM meds was a bowl of island pineapple flavored jello. This AM a glass of grape juice. Yesterday in the morning was a bowl of cereal and whole milk. Friday night was a can of beef raviolis. Friday a bag of eggs - white chocolate coat and peanut butter fill - whole bag. Several snacks with a sweet taste craved - maybe menstrual cycle related or related to a diet or blood need that is insufficient or not being filled. Sunday following vaccine, there is an odor. Sunday morning call to nurse line mentioned on back of health insurance card to ask if okay to remove band aid and mention any symptoms. Sunday afternoon some sweats break out after having coffee.
Fatigue and muscle aches about 24 hours after. Fever of over 102 about 36 hour after Early menstrual cycle, heavy with cramps a week after vaccine
c/o urinary frequency and incontince, weakness.acute cystitis due to ecoli,  COVID+ no symptoms (denied cough, SOB, fever, chills) gave emperic remdisivir. remained on RA. cefriaxone for cystitis
Information was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 20-JUL-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L041206 (dose, route and expiration date not reported). Concomitant therapy was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
depressed; drained; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 23Apr2021 10:30 (Lot number: ER8761) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: Oct2020 (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "insomnia" (unspecified if ongoing); "injury to shoulder NOS" (unspecified if ongoing); "Post-traumatic stress disorder" (unspecified if ongoing); "intense nausea" (unspecified if ongoing); "terrible pains in my heart and my chest" (unspecified if ongoing); "terrible pains in my heart and my chest" (unspecified if ongoing); "lost some weight" (unspecified if ongoing); "lots of body pain" (unspecified if ongoing); "Pain" (unspecified if ongoing); "STRESS" (unspecified if ongoing). Concomitant medication(s) included: LIDOCAINE taken for pain. The following information was reported: DEPRESSION (non-serious) with onset 05May2021 02:00, outcome "not recovered", described as "depressed"; FATIGUE (non-serious) with onset 05May2021 02:00, outcome "not recovered", described as "drained". Therapeutic measures were not taken as a result of depression, fatigue.  Additional information: Administration time was 10:30Am. Patient not received other vaccine in four weeks. Other medications in two weeks was lidocaine for pain. No treatment received for AE. Covid was prior vaccination. Covid was not tested post vaccination. No any known allergies.  No follow-up attempts are possible. No further information is expected.
3 doses given as a child and is not immunized; This case was reported by a physician and described the occurrence of therapy non-responder in a 23-year-old female patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included HBV (Engerix B pediatric) for prophylaxis and HBV (Engerix B pediatric) for prophylaxis.   On an unknown date, the patient received the 1st dose of Engerix B pediatric, the 2nd dose of Engerix B pediatric and the 3rd dose of Engerix B pediatric. On an unknown date, unknown after receiving Engerix B pediatric, Engerix B pediatric and Engerix B pediatric, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.   Additional Information: GSK Receipt Date: 19-Apr-2022 Reporter's comments: The patient received three doses of Engerix-B, pediatric doses given as a child. But the patient was not immunized. No further details were provided to the first line specialist. Second line specialist attempted callback but physician was not available at the time of call, so no further details were obtained. As event was not noted by first line during the call, it was not asked of the physician whether safety had permission to follow up.
This spontaneous report as received from a healthcare worker refers to a 2 year old patient of unknown gender. Healthcare worker stated that on 17-APR-2013, a dose improperly stored of RECOMBIVAX HB (lot number reported as 0366AE, exp. date 10-NOV-2014)(0.5 ml, intramuscular) was administered to the patient. Concomitant medications were not reported. Healthcare worker stated that RECOMBIVAX HB had multiple temperature excursions including exposure to 27F for 0.5 hours and up to 48F for 4 hours. No adverse effects reported. The case is linked to cases MARRS # 1307USA002435, 1307USA002434, 1307USA001233, 1307USA002436 via same reporter link. Additional information has been received. The lot number 0366AE, is an invalid lot number for RECOMBIVAX HB. This is a valid lot number for ZOSTAVAX. Additional information has been requested.
This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with M-M-R II, HSA (dose, lot # and route were not reported), after being stored improperly. No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected due to the reporter did not want to be contacted again.
Mom called stated pt was chilling yet felt hot by the time they got home; pt stated stomach hurt; t104 during noc but @ time of report was 102; APAP given; recommended mom take pt to clinic; mom concerned pt never gotten sick fr inject;
48 hours after receiving the vaccine, I started experiencing symptoms of an overactive bladder - had to urinate much more frequently than normal. 72 hours after the vaccine, I had a visible herpes outbreak in the genital region.
I had Cancer treatment on the 18th, COVID-19 shot on the 20th, and a pnuemonia shot on the 25th. My resistance was down  and I contracted COVID-19. Started off as just mild cold symptoms- itchy ears, runny nose, coughing, scratchy throat. That started Sunday night and into Monday. I thought it was just allergies, but my boyfriend encouraged me to get tested. I called the Doctor's office and gave them my symptoms and explained that I did not want a rapid test or anything over the counter. I wanted to go to a facility, because my sister had gotten several false positives. I made an appt for a drive through facility and I drove in and got tested and 6 hours later had the positive result. They then gave me the "antiviral hotline" where I completed a self assessment survey to determine if I could receive the antivirals. I am part of a healthcare system and once I had tested positive it notified all of my doctors, like my oncologists, and GP. I was concerned about my cancer treatment and about isolation guidelines, and they were able to guide and comfort me. I started taking Paxlovid yesterday evening, Wednesday. The medicine tastes absolutely horrible, very bitter. It effects my taste buds just like my cancer treatments. Nothing helps with the taste. My throat is still itchy and my ears are itchy and I'm a little congested but not as bad as a few days ago. I have cancer in my lungs so I am always coughing but I could tell the difference between this new cough and I am still coughing a little. My breathing feels better, I had previously experienced some chest pressure, like an elephant.
received a dose that had expired; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 34-year-old female patient who received HAV (Havrix 1440) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   On 29th June 2022, the patient received Havrix 1440. On 29th June 2022, unknown after receiving Havrix 1440, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional Information: GSK Receipt Date: 29-JUN-2022 Reporter's comments:  The reporter stated that the patient received a dose of Havrix 1440 EL.U that had expired on 18th June 2022. The reporter consented to follow up. Additional Supportive Information: The reporter stated that a patient received an expired dose of Havrix 1440 which led to, expired vaccine used.
Numbness and tingling in arms and legs; Started with dead arm immediately after shot. Moved to left leg, then other side of the body a few days later.; Numbness and tingling in arms and legs.; Rapid heart rate; Palpitations; Inability to sleep.; This is a spontaneous report from a contactable other healthcare professional, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 01Apr2021 at 15:30 (at the age of 29-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021, the patient experienced numbness and tingling in arms and legs, started with dead arm immediately after the shot. It moved to left leg and On an unknown date of Apr2021,  a few days later, it moved to other side of the body. The patient also experienced rapid heart rate and palpitations and inability to sleep. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events- numbness and tingling in arms and legs, started with dead arm immediately after the shot and then moved to left leg, moved to the other side of the body, rapid heart rate, palpitations and inability to sleep was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
NO ADVERSE EVENTS NOTED. CALLED PATIENT AND SPOKE TO DAUGHTER. DID NOT REPORT ANY ADVERSE EVENTS POST VACCINE, WAS TOLD TO GIVE US A CALL TO FOLLOW UP IF ANY SYMPTOMS SHOULD OCCUR AND TO SPEAK TO PHYSICIAN
Nausea; Flu symptoms; This case was reported by a consumer via call center representative and described the occurrence of nausea in an unspecified number of adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced nausea and flu symptoms. On an unknown date, the outcome of the nausea and flu symptoms were unknown.   It was unknown if the reporter considered the nausea and flu symptoms to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. A pharmacist reported to the consumer that he had some people report it was so bad and she would not be abled to work for two days. The patients received Shingrix, and experienced nausea and flu symptoms. At the time of report, the consumer was terrified. No further information provided and the call was remotely disconnected prior to more information being captured.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 15-OCT-2015, the patient was inoculated at a store pharmacy (by an unspecified health care professional) with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, and the female patient subsequently contracted a persistent strain of herpes zoster. On or about 15-MAY-2016, the patient was treated (by an unspecified health care professional) at a primary care facility for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Vaginal discharge; Sore sort of like a yeast infection; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL DISCHARGE (Vaginal discharge) and FUNGAL INFECTION (Sore sort of like a yeast infection) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included Celiac disease and Graves' disease.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VAGINAL DISCHARGE (Vaginal discharge) and FUNGAL INFECTION (Sore sort of like a yeast infection). At the time of the report, VAGINAL DISCHARGE (Vaginal discharge) and FUNGAL INFECTION (Sore sort of like a yeast infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
This spontaneous report as received from an unspecified reporter (Control #54417) concerning a 90 year old female patient. Medical history and concurrent conditions were not reported. Patient had no known allergies or any trouble breathing. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose and route were not reported) Lot # J011651; Expiration date: 22-AUG-2015 (reported as 31-AUG-2014). On 26-FEB-2014 (considering that the 90 year old patient was the last one reported), the patient had swelling of the arm, body aches, weak and fever. Patient did not had any trouble breathing and have no known allergies. Once patient was put on antibiotics, patient got better. The outcome of the events was not reported. This is one of 4 reports from the same reporter. Additional information has been requested.
Increased heart rate from 12:00am-5am, full body twitching from 2:00am- 9:00 pm. Slight muscle spasms still occurring.
Touched it and it was warm; Hard and firm for a week/Injection area hard/Hard elevelated area/Bump; Arm soreness; Injection area slightly red/After putting ice, it was more red (added redness); Swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Touched it and it was warm), VACCINATION SITE INDURATION (Hard and firm for a week/Injection area hard/Hard elevelated area/Bump), VACCINATION SITE ERYTHEMA (Injection area slightly red/After putting ice, it was more red (added redness)), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE PAIN (Arm soreness) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection area slightly red/After putting ice, it was more red (added redness)) and VACCINATION SITE SWELLING (Swollen). On 09-Jan-2021, the patient experienced VACCINATION SITE INDURATION (Hard and firm for a week/Injection area hard/Hard elevelated area/Bump) and VACCINATION SITE PAIN (Arm soreness). On 15-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Touched it and it was warm). On 10-Jan-2021, VACCINATION SITE PAIN (Arm soreness) had resolved. At the time of the report, VACCINATION SITE WARMTH (Touched it and it was warm), VACCINATION SITE INDURATION (Hard and firm for a week/Injection area hard/Hard elevelated area/Bump), VACCINATION SITE ERYTHEMA (Injection area slightly red/After putting ice, it was more red (added redness)) and VACCINATION SITE SWELLING (Swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Patient used cold compress for treatment.