chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sensorineural hearing loss; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a female patient (pt) of unknown age. No information regarding the concurrent conditions, medical history and concomitant medications was provided. On or around 12-AUG-2011, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dosage, anatomical location and route of administration were not provided) for routine health maintenance and for its intended purpose, the prevention of shingles (herpes zoster). Shortly after receiving the vaccine, the pt suffered and was diagnosed with sensorineural hearing loss (deafness neurosensory). As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccination, the pt's symptoms had resulted in physical limitations not present prior to inoculation. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result, the pt sustained severe and permanent personal injuries. Further, as a tragic consequence the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, she also suffered and incurred damages, including medical expenses; loss of accumulations; and other economic and non-economic damages. At the reporting time, the pt had not recovered from deafness neurosensory. The reporter considered deafness neurosensory to be related to zoster vaccine live (ZOSTAVAX).   Upon internal review, the deafness neurosensory was considered a medically significant and disabling event.
The patient experiences swelling, redness and itchiness in the site of injection, within 24 hours after Td vaccine was administered. Follow up on 06/18/04: Patient's doctor was contacted and stated that the patient recovered.
This spontaneous report as received from a consumer regarding her son refers to a 10 year old male patient. No information about medical history, concurrent conditions and concomitant medications were reported. The reporter stated that the patient had received his first dose of M-M-R II around 12-15 months on an unspecified date. The reporter also mentioned that after the patient received the first dose of M-M-R II and prior to the start of her son entering elementary school, titers were drawn and immunity to M-M-R II were present. It was also reported that patient had never received a second dose of M-M-R II and the patient is now 10 years old and was requested by the school to have titers for immunity drawn again or to have the patient received the second dose of M-M-R II. On an unspecified date titers were drawn and immunity for measles was not present. The reporter also stated that patient had an unspecified learning disorder since an unknown date. The outcome of events reported is unknown. No product quality complaint was involved. Additional information is not expected as the reporter refused additional contact.
Fever 102.7.  Chills, lethargy, stomach upset, lack of appetite.  Extreme pain in shoulder at vaccine site lasting 12 days.  Lost 5 lbs in two weeks.
I began experiencing symptoms of flu, Congestion and headache two days after receiving the first dose vaccination. After five days, I got a strong headache and went to seek urgent care, They did a covid test, it was negative. and now day 7 the symptoms continue Like vomiting, cold, Diarrhea and severe headache.  I went to urgent care again and got a check-up and they gave me an antibiotic. I want to know if these symptoms are due to the vaccine, Can I not take the second dose or delay it, Because I'm afraid of the second dose?
Pt received vaccines yesterday between about 10:30-11:00 am, several hours later (came to urgent care clinic about 6pm) with widespread rash which was dx'd as urticaria, and with periorbital edema. Pt had no g.i. or respiratory symptoms at all. Rash and edema have resolved through the night and pt presents to us this am in no distress, for a recheck.
No additional AEs reported; GARDASIL 9 was administered following a temperature excursion; This spontaneous report was received from an office manager referring to a 10-year-old female patient.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 04-FEB-2023, the patient was vaccinated with one dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe injection, administered as prophylaxis (there were five possible lot # of the vaccine administered: lot #1775811, expiration date: 07-DEC-2023; lot #1775827, expiration date: 27-JUN-2024; lot #W009829, expiration date: 19-OCT-2024; lot #U032681, expiration date: 26-OCT-2023; and lot #1780876, expiration date: 09-NOV-2023; however, it was not specified which one was received by the patient) (strength, dose, route of administration, anatomical location, and vaccination scheme were not provided). It was reported that the vaccines suffered from three temperature excursions with a total of 25 minutes (on 09-SEP-2022 for 8 minutes; on 16-SEP-2022 for 5 minutes; and on 03-JAN-2023 for 12 minutes). The excursions were not noted until it was noticed that an employee mistakenly cleaned the data logger more than once a day (product storage error). There were no additional adverse events (AEs) reported in the patient (no adverse event).  This is one of several reports received from the same reporter.
In addition to soreness at injection site, flu-like symptoms (aches, chills, fatigue) began about 3 hours after injection and became worse over time. The day after the injection I felt as if I had very bad flu and stayed in bed much of the day. I felt much better after another night's sleep, just somewhat washed out and the injection site was still tender. I had the ZOSTAVAX injection about two years before.
he had difficulty eating much; tremendous amount of pain on his left side of his body; For a month after, he was extremely nauseous; This spontaneous case was reported by a consumer and describes the occurrence of EATING DISORDER (he had difficulty eating much), MYALGIA (tremendous amount of pain on his left side of his body) and NAUSEA (For a month after, he was extremely nauseous) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 408D21A) for COVID-19 vaccination.     Concomitant products included GABAPENTIN, IBUPROFEN (IBUPROFEN 2CARE4) and PARACETAMOL (TYLENOL) for Pain.    On 23-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Aug-2021, the patient experienced EATING DISORDER (he had difficulty eating much), MYALGIA (tremendous amount of pain on his left side of his body) and NAUSEA (For a month after, he was extremely nauseous). At the time of the report, EATING DISORDER (he had difficulty eating much), MYALGIA (tremendous amount of pain on his left side of his body) and NAUSEA (For a month after, he was extremely nauseous) outcome was unknown.            This case was linked to MOD-2021-342936 (Patient Link).
This case was reported by a pharmacist via call center representative and described the occurrence of influenza like illness in a 79-year-old male patient who received SHINGRIX (batch number Y24KE, expiry date 11th October 2020) for prophylaxis. On 25th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In July 2018, several hours after receiving SHINGRIX, the patient experienced influenza like illness, woozy, headache, general body pain and difficulty breathing. In July 2018, the outcome of the influenza like illness, woozy, headache, general body pain and difficulty breathing were recovered/resolved. It was unknown if the reporter considered the influenza like illness, woozy, headache, general body pain and difficulty breathing to be related to SHINGRIX. Additional details were provided as follows: At 11:00, the patient received the SHINGRIX vaccine. Overnight the patient felt like he was getting the flu. The patient felt woozy, had a headache and body aches and briefly felt short of breath. Within 3 to 4 hours, all of these symptoms were resolved.
At approx 7:00 in evening patient developed itching and noticed her back right side was covered in hives and a rash, she also then developed lymphedema down her right leg and up into her armpit on the right side. She also reports having a fever of 101, joint/muscle pain, and charlie horses.
Received SPV on 09/15/2004.  Began having symptoms of substernal chest discomfort on 09/24/2004.  Initially mild symptoms progressed to point where it significantly limited his activity and progressed to rest discomfort.  Increased discomfort noted with lying down that was then slightly relieved with sitting up.  No viral illness prior to immunization.  Presented to ER on 09/24 where he had slightly elevated cardiac enzymes with a normal EKG.  As of 01/31/2005 he is able to do full PE, run 2-3 miles at good speed, and lift weights without problems.  No chest pain for about a month now.
This case was reported by a other health professional via call center representative and described the occurrence of injection site burning in a 36-year-old male patient who received BEXSERO (batch number 169701, expiry date January 2019). On 19th April 2018, the patient received the 1st dose of BEXSERO (intramuscular). On 19th April 2018, immediately after receiving BEXSERO, the patient experienced injection site burning and injection site discomfort. On 20th April 2018, the patient experienced muscle soreness. On an unknown date, the outcome of the injection site burning, injection site discomfort and muscle soreness were recovered/resolved. The reporter considered the injection site burning, injection site discomfort and muscle soreness to be related to BEXSERO. Additional details were provided as follows: The patient received SHINGRIX vaccine on right deltoid. The physician (MD) called and stated that, the patient received first dose of BEXSERO (unsure of time) and complained of burning, pain and discomfort on entry during administration of BEXSERO. The patient also experienced general soreness on the next day of vaccination. The physician put physician assistant on the phone to provide additional details. Everything resolved but unsure when it resolved. The physician and physician assistant were unsure if patient took anything for symptoms.
generalized body itch w/red, raised rash on chest & face; this began 1/2 hr p/inject given & lasted 1 1/2 hrs; 440PM (3 hrs p/inject) became mildly nauseated;
4/16 noted lymphadenopathy; 4/17 increased swelling and tenderness; 4/18 cont. swelling less tenderness.
Moderna vaccine was administered through a BIOCLUSIVE adhesive dressing/bandage; Something leaked out of the injection site- either blood or vaccine; This spontaneous case was reported by a nurse and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Moderna vaccine was administered through a BIOCLUSIVE adhesive dressing/bandage) and VACCINATION SITE DISCHARGE (Something leaked out of the injection site- either blood or vaccine) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to some antibiotics. Causes rash and hives.).    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 17-Mar-2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Moderna vaccine was administered through a BIOCLUSIVE adhesive dressing/bandage) and VACCINATION SITE DISCHARGE (Something leaked out of the injection site- either blood or vaccine). On 17-Mar-2021, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Moderna vaccine was administered through a BIOCLUSIVE adhesive dressing/bandage) had resolved. At the time of the report, VACCINATION SITE DISCHARGE (Something leaked out of the injection site- either blood or vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Products known to have been used by the patient, within two weeks prior to the event, included none. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-048265 (E2B Linked Report).; 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.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-048265:Crosslinked case
Saturday night (3/13/21) and into Sunday morning (3/14/21), patient began feeling discomfort in lower right leg. Discomfort and feeling of swelling continued through Sunday evening. Monday (3/15/21) patient began using compression stocking and elevating leg, which eased some discomfort. Slight swelling, discomfort, and heat in the leg continued throughout entire week. DVT presumed. Contacted physician. Treatment for DVT and treatment dosage (Fondaparinux 7.5mg) commenced Wednesday (3/17/21) through to date. Discomfort has dissipated but slight swelling still remains. Appears to be getting better each day, although a very slow progression. Patient history of antiphospholipid syndrome has been managed for over fifteen years with blood thinners. Onset of a clotting event always followed a justifiable cause. No spontaneous/unexplainable clotting events to date. Patient otherwise healthy without any other current event which could explain a blood clot following vaccination. Reporting this information as it may be helpful in determining whether persons with APS or similar condition should receive Covid-19 vaccination. Note: this information being provided by patient.
Severe anxiety that has lead to panic attacks. I ended up in the ER twice thinking I was having heart issues. My doctors have lead to believe that after blood work, heart scans, with Cardiologist, Rheumatologist, Pulmonologist, ENT.
12/26/21 presents to EC ED for "acute onset lightheadedness and dizziness". PMHx of "chronic hypoxic respiratory failure on 4 L O2 nasal cannula, COPD, paroxysmal atrial flutter s/p DCCV on Eliquis, chronic diastolic CHF, essential hypertension, coronary artery disease, venous insufficiency, abdominal aortic aneurysm, arthritis and pulmonary hypertension"
A dose of the Moderna vaccine was left over from the prior day vaccinations. The dose had been set aside for disposal, the technician preparing for the days vaccinations grabbed the dose by mistake and may have administered to the above patient.
Bell's palsy, half face paralyzed; Got really sick; This case was reported by a consumer via interactive digital media and described the occurrence of bell's palsy in a patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced bell's palsy (serious criteria GSK medically significant) and sickness. On an unknown date, the outcome of the bell's palsy and sickness were unknown.   The reporter considered the bell's palsy and sickness to be possibly related to Flu vaccine.     Additional Information: GSK Receipt Date: 05-JAN-2023 Reporter's Comment: The case was received from the patient's parent via interactive digital media. The patient got the flu shot one year and got really sick while half the face went paralyzed (Bell's palsy). The patient reported this as side effect from the flu shot.  The patient stated that it was funny though, so he/she never got another flu though. Additional Supportive Information: The follow-up could not be possible as no contact details were available.
Felt sluggish after vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A patient (no qualifiers provided) 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: SLUGGISHNESS (non-serious), outcome "recovering", described as "Felt sluggish after vaccine".  No follow-up attempts are possible. No further information is expected.
Chills, fever 101 and 103.2, nausea, body aches
Within an hour or so after getting the shot I felt very tired but I did go to work that evening.  The next  morning I got up and was completely exhausted, had a dull headache that got worse as the day went on eventually ending in my neck, I also had ringing in my ears and dizziness throughout the day whenever I would wake up but this did not last long in between each time that I woke up throughout the day.  I chose not to go to the doctor or hospital as I just felt lousy and stayed in bed and administered self care (that was yesterday, Wednesday, February 17, 2021).  Today, Thursday, February 18, 2021 I chose to stay home from both my jobs even though most of the symptoms have not returned but I am still very tired!  As for treatments; I drank lots of water, took Tylenol and Motrin (as appropriate per package) during different parts of the day, ate in moderation, and slept a good portion of Wednesday 2/17.
Approximately 5 minutes after receiving vaccine, patient started feeling chest tightness and increased heart rate and decreased oxygen. She was give 75 mg of Benadryl, and it did not help. 1 Epipen was administered and symptoms improved, but they began to return and a second epipen was administered approximately 30 minutes after the first epipen. EMS was already on site at that point and patient was taken in ambulance to hospital.
shingles symptoms, tingling nerves in the scalp, pressure in the sinus through a course of a month.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient (Company representative) concerned a 48 year old male of unspecified ethnic origin. The patient's weight was 190 pounds and height was 70 inches. The patient's concurrent conditions included: ragweed allergy, pollen allergy, alcohol use (Occasionally), and non-smoker, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 204B21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 18-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  Starting on 12-SEP-2021 (reported as Sunday night) through the week of report, the patient had stuffy nose, sneezing, loss of sense of smell, and was more tired than normal. On 16-SEP-2021, the patient was tested for COVID19, and received positive result on 17-SEP-2021 (Suspected covid-19 infection and suspected clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case was associated with Product Quality Complaint.; Sender's Comments: V0: 20210937243-covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
very large lump next day, 1/2 baseball, red , tingling down arm  after shot for 40 minutes.
I started noticing my left ear was unusually full and a slight loss of hearing when making my first call of the day on my cell phone.  The loss of hearing slowly went away throughout the day, but i developed ringing in my left ear.  I went to the doctor for a hearing test that showed that i couldn?t hear high pitched noises that resembled the pitch that i am hearing in my ear.  The ringing went down after the summer, but it still hasn?t gone away after 1 year.  I got my vaccine about 1 year ago in March of 2021.
20 Days post Covid 19 updated vaccine booster I developed abdominal pain (7/10 pain rating) and went to ER. I was 14 weeks 5 days pregnant at the time (estimated due date of April 14 2023). Ultrasound could not detect appendix due to pregnancy, so an MRI was ordered. MRI confirmed acute appendicitis and an appendectomy was performed and antibiotics administered. The MRI report also noted an enlarged spleen though no clinical follow up was performed. Fetal heart tones were confirmed after surgery and follow up with OB will occur due to surgical intervention during pregnancy.  Not sure if it is vaccine related but appendicitis is now listed under serious adverse events under the vaccine so I wanted to report.
This spontaneous report was received from a licensed practical nurse, and refers to a 66 year old male patient. The patient had none pertinent medical history, concurrent conditions, drug reactions or allergies. The patient had none concomitant therapies. On 06-SEP-2017, the patient was vaccinated with PNEUMOVAX 23, lot # N011867, expiration date 08-NOV-2018, for prophylaxis (dose, dose number, route, and anatomical location were unspecified). On 07-SEP-2017, the patient went into the reporter's office with fever of 102 (units not provided), chills, and his left arm was red, swollen and very painful. The patient stated that "he could not pick up anything with his arm." The outcome of the events was reported as not recovered. No treatment was given for the adverse events and none laboratory diagnostic studies were performed. The relatedness between the events and PNEUMOVAX 23 was not reported.
Information has been recieved from a physician referring to 14 anonymous patients of unknown age and gender. Patients' concurrent conditions, concmitant medicationa nd medical hsitory were not reported. On unknown dates between 12-APR-2015 and 30-JUN-2015, the 14 patients were vaccinated with expired GARDASIL (lot # H016238, expiry date 11-APR-2015, dose and route were not provided). The physician reported that the GARDASIL had previous temperature excursions on unknown dates and was unable to provide the excursion details at this time. No adverse symptoms were reported. The physician called back on 09-JUL-2015 and provided the names of 14 patients administered improperly stored and expired doses of GARDASIL. Physician did not specify what dose in the GARDASIL series was administered to each patient. One of the patients was administered the vaccine on 07-MAY-2015. This is one of several reprots received from the same reproter. Additional information has been reuqested.