chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hospitalized on 3/31 following episode of unresponsiveness and confusion that started roughly 18hrs after vaccination. Patient had similar presentation requiring hospitalization after first vaccine dose as well  Initially presented to Hospital.  Workup there included empiric antibiotic therapy, antiviral therapy did not result in improvement, MRI brain and lumbar punctures non-significant, required intubation early in admission for a brief period, then likely developed HAP/VAP and ARDS requiring re-intubation and was transferred to higher level of care our main campus  facility from which I am reporting this.   Here,  rheum/neuro workup largely negative. Her course has been c/b multiple DVTs and Aflutter that has resolved. So far, workup for AMS and fevers have been extensive -- BEM, LP, MRI, thora, bronch w BAL were unremarkable. The patient has been monitored off abx without hemodynamic changes. She did not improve despite various abx administered and did not really respond to seroquel for her delirium. At one point, the husband was considering hospice because nothing had improved her clinical status. Given her rheumatologic hx and declining mental status after the vaccine, the patient was treated with methylpred 1 daily x3 and this dramatically improved her clinical course. She began to wake up and per the ICU, was AOx2-3 at one point, whereas she had not responded even to painful stimuli at one point. She still did have some hypoactive delirium. At this point, she was deemed stable enough to be transferred. Our phsyicians were following her through the admission, was not aware and speaking again until 5/5/21.   Currently she is undergoing epilepsy workup and is still hospitalized.
from nursing home for lethargy and altered mental status, onset this evening.  Two initial EKGs were negative for ischemia.  Troponin came back positive.  Evaluated for NSTEMI, continued to monitor and started to see trending down troponin. Continued to monitor over several days and provider discussed with family and no intervention done. Improved over time and discharged to skilled nursing facility
Pt complained of nausea, dizziness, chills, headache abdominal pain with severe generalized abdominal pain  to palpation as well as substernal chest pain.  This occurred one hour after vaccination.  He was sent to ER.
It was reported that a female pt received Fluzone SV '98-'99 USP on 11/27/98 and reportedly, the pt has asthma and an allergy to feathers, and was told by allergists to receive IZ. The pt experienced a local reaction, numb limps, and lightheadedness that evening of the vaccination.
patient had experienced blurry vision starting 1 hour after receiving the vaccine.the vision had gotten worse since then and today he came to pharmacy to report the issue. the eyes looked little red as well. we recommended that patient go see an ophthomalogist
Patient stated that face, hands swelled and was itchy. Patient also states that vaginal area was also itchy.
3-4 hours post vax the pt broke out in a red rash all over his body. Pt was advised to seek medical attention if rash didn't improve or other symptoms of possible reaction occurred.
Skin rash and skin lesion on upper extremity. Prednisone 5 mg every day, Ammonium lactate 12% ml BID.
I (patient) woke up to use bathroom and I was itching all over at 2am.  I noticed rash on my legs and buttocks. That morning I went to work and throughout the day the rash progressed and more "spots" developed. They are raised and have a clear head to some of them.  I did not eat anything different or change detergent.  My husband did not have this rash following sleep on 6/04/12.  The only change in routine was receiving the 3rd Gardasil vaccine shot.  I am itching all over. The welts are on both legs both on the front and backside of my legs, on both buttocks, around the bikini area and I have these "raised spots/rash" on both arms and back also as of 6pm on 6/05/12.
Pt. felt dizzy in the observation area.  Paramedics assessed vitals.  Once pt. symptoms subsided pt. was released
Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 26-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 2.5 ml/five dose vial, lot # K007773 and expiration date 01-MAY-2015 (administration route was not provided). No adverse effects were reported. The vaccine had one temperature excursion of 48 hours with a lowest recorded temperature of 1 Fahrenheit (F) Celsius (C)). The storage criteria and the type of excursion for this vaccine was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
requested pt's records twice without receiving them; pt had a positive COVID test on 1/7/21; had a hospital stay from 1/7/21 - 1/21/22; per death certificate, pt passed away in the hospital with causes of death being COVID 19 pneumonia, COVID 19 viral infection, AHRF secondary to COVID 19.
Eight hours after receiving the vaccine.  I started feeling flu like symptoms. Skin felt sensitive, had muscle and joint aches,  and the inside of my body felt very busy like a raging machine working very hard and getting very hot.  The outside of my body was cool however.  This lasted from about 10:15 PM to 6:00 AM, keeping me awake all night.  At 6:00 AM finally fell asleep for three hours.  The rest of that day felt like a mild flu and my body had this weird sensation that it was busy inside almost like drinking too much coffee. The site of the shot was quite sore and only mildly swollen.  The next day I was OK and the  site of the shot was much better, the site of the shot discomfort was gone by the following day.
Patient called into the pharmacy within an hour after receiving his booster shot of the moderna covid vaccine reporting a chlorine-like taste in the mouth. He said he also experienced this after other doses in the series.
48 hours after receiving inj, pt noticed redness, swelling, induration pain with progression of symptoms.  Localized reaction with possible cellulitis.  Treated with Doxycycline, Claritin, Ibuprofen.
A report was received from a health care professional on 11/02/03 concerning a 50 year old female vaccinee who inadvertently received expired Fluvirin on 11/01/03. The vaccinee had experienced no adverse reaction at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1, 02/02/04: A follow up report was received from a health care professional indicating that the vaccinee inadvertently received 1ml of expired Fluvirin on 11/01/03. No adverse events were reported at the time of the follow up report. No follow up pending, all information received. See ref>: PJP200300968 and PJP20030970>
hearing loss; This initial spontaneous report was received from a lawyer and a female patient of unknown age regarding a case in litigation on 04-MAR-2020. The patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided. On or about 19-JAN-2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, lot #, expiration date, route of administration and anatomical location not provided), by a healthcare provider at the clinic, for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to vaccination, on an unspecified date, the patient was treated by a healthcare provider at the hospital for zoster related hearing loss. As a direct an proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient had a would continue suffer ongoing injuries, including but 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 included 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. At the reporting time, the outcome of hearing loss was considered as not recovered. The reporters considered hearing loss to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review the event of hearing loss was determined to be medically significant.
Vertigo/ dizziness.  I woke up at 3 AM and could barely stand up? I had a really bad headache and was very lightheaded and dizzy. It lasted a couple hours. It has been one week since those symptoms started and I still experience bouts of dizziness and lightheadedness throughout the day.
fever , chills, headache , body aches, fogginess  Missed work x 1 day
bells palsy on side of face; bells palsy on side of face, broken blood vessels around eye; loss of 2 teeth; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (bells palsy on side of face) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (bells palsy on side of face) (seriousness criterion medically significant), ANGIOPATHY (bells palsy on side of face, broken blood vessels around eye) and TOOTH LOSS (loss of 2 teeth). At the time of the report, BELL'S PALSY (bells palsy on side of face), ANGIOPATHY (bells palsy on side of face, broken blood vessels around eye) and TOOTH LOSS (loss of 2 teeth) outcome was unknown.            No concomitant drugs were reported. It is unknown if the patient experienced any additional symptoms/events. Treatment drugs were not provided.  Company Comment: This is a Spontaneous case reported by a consumer, concerning an adult female patient, with no medical history reported, who experienced the expected and serious (due to medically significant) AESI of Bell´s palsy, which occurred on an unknown date related to mRNA-1273.222 vaccine, administered as second dose within COVID-19 vaccination schedule. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.
Two days after my second vaccine I developed a rash on both sides of my neck as well as the back of my neck but not the front. On my chest, shoulders, hairline, and face. I was miserable with the itching.
CDC reports: 15mo child developed hives following DTP/OPV/MMR immunization.
patient received a dose that had an expired diluent component; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA729A, expiry date 30-SEP-2023) for prophylaxis.   On 05-OCT-2023, the patient received Menveo. On 05-OCT-2023, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: patient received a dose that had an expired diluent component).  The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 05-OCT-2023 Clinic Manager reported a Medical Assistant pulled a Menveo vaccine and saw that the expiration date was OCT-2023, however when entering she noticed that there was another expiration date of SEP-2023 also listed. Therefore, the patient received a dose that had an expired diluent component, which led to expired vaccine used. The dose was administered to a 16 year old female patient. At the time of reporting, a repeat dose had not been administered. The reporter consented to follow up.
8/28/13 Date of vaccine, redness, swelling pruritis size of silver dollar. 8/29/13: Redness, swelling, itching at site of injection  1"x3"-the red irritation; 8/31/2013 Mid chest itching, no rash. Benadryl on 8/29, 9/1; 9/1/13 Back covered in hives.
little sore right arm; stomach quizzing, did not threw up; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (little sore right arm) and ABDOMINAL DISCOMFORT (stomach quizzing, did not threw up) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (little sore right arm) and ABDOMINAL DISCOMFORT (stomach quizzing, did not threw up). On 12-Feb-2021, PAIN IN EXTREMITY (little sore right arm) and ABDOMINAL DISCOMFORT (stomach quizzing, did not threw up) had resolved.        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.   No concomitant medications were reported.  No treatment medications were provided by the reporter.
pt recvd flu vax & exp pain in the lt upper arm, above inject site; pain was treated w/arthritis-strength aspirin w/no relief; Dolobid did not provide a favorable therapeutic response nor did corticosteroid therapy; pt ex limited mobility;
Generalized urticaria (scalp, trunk, extremities) with no visible rash. Began approximately 24 hours post-injection. Advised Benadryl every 4-6 hours as needed to control itching and to seek medical attention if worsens or develop  SOB/cough. Sx's allergic rxn. Under treatment.
he caught the disease/Suspected vaccination failure; he caught the disease; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced vaccination failure (serious criteria hospitalization and GSK medically significant) and meningococcal infection (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the vaccination failure and meningococcal infection were unknown.   It was unknown if the reporter considered the vaccination failure and meningococcal infection to be related to Meningococcal B vaccine.  Additional details were reported as follows: The age at vaccination was not reported. It was reported that. the patient received vaccine and ended up in the ICU after he caught the disease and really had to stop endorsing faulty products. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation for meningitis were not provided.
more than 35 days since first dose; Itchy; Rash in chest; rash in forehead; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (more than 35 days since first dose), PRURITUS (Itchy), RASH (Rash in chest) and RASH (rash in forehead) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (experienced an anaphylactic reaction to Amoxicillin). Concomitant products included VITAMINS NOS, UBIDECARENONE (VITAMATE COENZYME Q10) and VITAMIN D NOS for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (more than 35 days since first dose), PRURITUS (Itchy), RASH (Rash in chest) and RASH (rash in forehead). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 15-Jan-2021, PRODUCT DOSE OMISSION ISSUE (more than 35 days since first dose), PRURITUS (Itchy), RASH (Rash in chest) and RASH (rash in forehead) had resolved.        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.   Patient stated that  one or two hours after first dose ,patient experienced rash on forehead, chest and itch. And symptoms lasted for an hour. Patient stated her doctor advised not to take second dose.
I am not sure about the exact flu vaccine I was given, but I felt dizziness as I was leaving the medical facility immediately after the shot was administered. The next day woke up with severe dizziness and nausea and could not keep any food or drink down, threw up everything I ate or drank. Day 2, I am still feeling very dizzy. This is a very severe side effect and if I don't improve by tomorrow I will seek medical attention. I have never had such dizziness and there is no other reason for this, my blood pressure is normal and heart rate as usual. My husband has to hold me when I get up to go anywhere.
Initial report received on 04 March 2008 from the patient's uncle. A 7-month-old female patient, with a past medical history of "reflux", had received a first dose of FLUZONE SV 2007-2008 (lot number U2442AA) on 24 September 2007. The route and site of administration of the Fluzone vaccine was not provided. It was "unknown" if the patient had any illnesses at the time of the vaccination. Approximately two months post-vaccination, the patient experienced "seizures." The patient required an emergency room visit with subsequent hospitalization (date not reported). An electroencephalogram (EEG) was performed that revealed seizure activity. The recovery status of the patient was reported as "Unknown." No other relevant medically significant information was provided.
The lymph node near my left collar bone swelled up a week after my COVID vaccine. (It moves around if I push it). It is 1 cm in size.
I noticed in the the afternoon the day after receiving the vaccine that I was not tasting my food, I was eating mint Ice Cream and I could not taste the mint.  It was just wet cold and sweet. I also had a mild headache for about three days and I was very fatigued. A month later My taste has not improved and  is still very subdued.  I am very fatigued, all the time, energy level is very low. Having frequent headaches  and heart palpitations.
Patient experienced a life threatening condition Hospitalization Upset stomach Drowsiness Seizure activity Impaired speech and mobility Swelling tongue Abnormal heard rhythm Difficulty breathing Memory loss  The outcome results includes  long term rehabilitation, with occupation therapy and speech therapy.
This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction) and VACCINATION SITE SWELLING (Swelling at the injection site 10 days after) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Allergic reaction) and VACCINATION SITE SWELLING (Swelling at the injection site 10 days after). At the time of the report, HYPERSENSITIVITY (Allergic reaction) and VACCINATION SITE SWELLING (Swelling at the injection site 10 days after) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant product use was reported. No treatment information was provided.
Mild seizure activity.  It began approximately an hour after we got home from receiving the vaccinations.  She would throw her arms up and kick her legs up very much like she couldn't control it, all while screaming.  She couldn't eat or sleep for more then 8 hours.  It was almost like her central nervous system was just going haywire.  She had this happen every 30 seconds - 2 minutes for the rest of the night.  Within a week, she had returned to not doing this any longer.
Patient described experiencing dizziness. He was accompanied by partner, who was holding him closely. He then fainted, which was followed by a seizure lasting between 15-30 seconds. He did not collapse to the floor, as his partner let him down on the floor slowly. Patient then regained consciousness, and sat down while waiting for EMS. He continued to experience dizziness for the following 20 minutes. He was then transported by EMS to the hospital
Pharmacist administered Fluad shot to patient at 1258 pm 11/6/2021. Before the shot, patinet confirmed flu shot with patient  and patinet acknowledged flu shot and said " she got the flu shot previous before and what is different on this flu shot. Pharmacist told patient this was for elderly over 65 flu shot. Patient then let pharmacist proceed for flu shot. After adminstration of flu shot, patient told pharmacist " when will be good time to get pneumonia shot , next year?" This is when pharmacist realized patient actually expected Pneumonia shot Prevenar and at this point, patient showed pharmacist the Rx which doctor wanted. Later on, patient was worried because she had flu shot back in September 2021.
Information has been received from a certified medical assistant concerning a 10 year old female with allergic reaction to ZITHROMAX who on 17-JUN-1998 was vaccinated with the first dose of VARIVAX (Merck) and on 14-APR-2008 received the second dose of VARIVAX (Merck) (lot # 660082/1977U).  There was no concomitant medication.  The medical assistant reported that on 16-APR-2008, the patient's mother called the doctor's office because the patient developed swelling, redness and tightness at the VARIVAX injection site.  The entire upper right arm was warm to the touch and indurated.  The patient sought medical attention in the physician's office. The physician stated to be alarm that it had happened with VARIVAX (Merck) 3 times that month.  The physician reported that it looked like cellulitis but could be an immunogenic reaction.  At the time of the report.  The patient had not recovered.  This is one of several reports received from the same source.  Additional information has been requested.
Woke up Friday morning with chills. Temperature was 99.3. Slight headache and achiness. Fell asleep from 9-11:30.  Back to sleep from 1:30-3:30. Temperature was 100.3. Took Acetaminophen.  Just rested the rest of the day. Woke up Saturday feeling great.
pt reported mild dull headache and warm head.given water and saltines with improvement.   BP slightly elevated. Pt admitted to stress. Monitored for additional 30 min. Pt felt ok to go.
Narrative: A 75yo male with PMH of Depression, Renal Cyst, Cataract, PTSD, HTN, Hyperlipidemia and SCC. He presented to establish care with the PCC on October 13, 2022. The intern reported the patient had a historical ADR of influenza vaccine induced anaphylactic type reaction in the past. NO other information regarding the vaccine was provided in the physician intern's report. No documentations regarding the product, when and where it was administered or by who.
Pt recv vax on 2/3/99; on 2/5/99 pt exp petechial rash on trunk & upper extremities, tingling/ numb/ weak left upper arm
Vertigo and blurred vision.  Vertigo sudden onset day 7 post vaccine.  Blurred vision day 9 post vaccine.