chrisvoncsefalvay/vaers-outcomes huggingface dataset:
When I woke up the morning after my vaccine, I noticed that the tinnitus noise in my ear (due to Meniere's Disease) was extremely elevated.  It has remained elevated and very loud since my vaccination. (much louder than before my vaccination) . Before I barely heard it during the day, but mostly at night, but post-vaccine, I hear it all the time.  There is no treatment for tinnitus except to continue my daily dosage of Triamterene.  I will address it with my Dr. at my next appointment in April. I hope the outcome will be that my tinnitus returns to levels prior to the vaccine.
Fever 101 at 4:35P,  BP elevated on 7/8 1pm 192/84, pulse 97 O2 dropped to 90% on room air and continued to drop.  Resident was confused and less responsive. She was incontinent (not her usual).
This spontaneous report as received from an administering registered nurse refers to a patient of unknown age and unknown gender. On an unknown date the patient was vaccinated with a dose of PROQUAD (dose, route and lot# not reported) in the arm. The patient was also vaccinated with a dose of KINRIX (manufacturer GlaxoSmithKline) on the same arm. Subsequently, on an unknown date, the patient's arm swelled. The patient did not receive any treatment and did not seek any medical attention. On an unspecified date, the patient's outcome was recovered. Additional information is not expected.
Gave 2 pediatric doses of Hepatitis A, instead of 1 adult dose
Arthritis pain & swelling of all joints, especially hands; (every joint in hand affected) swelling & pain started one day p/inject persisted severly for 2 wks; lt knee & fingers still sl pain & swelling;
Developed a runny nose within 24 hours of receiving the vaccine. Was extremely cranky for several days later. Within 10 days of receiving the vaccine, nasal congestion cleared and a fever of 103 developed. She was given alternating doses of Tylenol and Motrin to control the fever but it never dipped below 103. She was taken to her Dr. on 6/23/2004 and diagnosed with borderline otitis media. No chest infection was present.I was given a prescription for Omnicef 125MG/5 ML Susp ABB and she received her first dose by 9:30 pm on 6/23/2004.  10 hours later, her fever spiked to 105 and she had a febrile seizure. She was taken to the ER and received Tylenol to help bring the fever down to 101. Her fever rose again throughout the night and early morning and was given overlapping, alternate doses of Tylenol and Mortin. She began to refuse solid food and would only accept about 1/4 of her ususal formula intake. She was extremely lethargic, refused to stand, crawl, sit or hold her head of and spent approximately 23 of the following 24 hours asleep. Waking only to take small amounts of formula and medication. On the evening of 6/24/2004 she awoke and began crying. I held her on my lap, belly to belly. During this time, she passed out, vomited and did not rouse until about 3 minutes after vomiting. Her fever remained steady between 104 to 105 degrees. The following morning, on 6/25/2004, I took her again to her pediatrician. He examined her stating her otitis media appeared to have cleared up, no chest infection but she was severely dehydrated and she had to be admitted to the local PICU. She was admitted on 6/25/2004 and began an IV drip only after several failed attemptes to locate a vein as she was so dehydrated. She received a chest x-ray, urine culture, CBC and other blood test. Her doctor informed me there may be a need to give her a spinal tap. During her stay at the hospital, her fever reduced and then became normal, x-ray and urine tests results were negative but blood tests suggested a viral infectionn that could not be positively determined. Throughout this time, all residents, nurses and her pediatrician reported no chest congestion of any kind, even when I asked specificall if any was detected. I was given several diagnoses throughout her stay at the hospital, from possible coxsackie, roseola, and it was intimated she may have meningitis. She was released from the hospital on 6/27/2004 with a normal temp, although she remained very sleepy and refused to eat or drink much for the next several days. On July 1, 2004 I met with her pediatrician for a follow-up visit and inquired as to what she could have had. He infoirmed me she was diagnosed with bronchitis, despite an absence of chest congestion or any cough. I inquired for the third time since her innoculation of Prevnar if this illness could have been a reaction to the vaccine, I was again told no, even though she originally presented with the very symptoms Prevnar was suppose to prevent.  Nurse follow up on 07/22/04 states: "Viral Syndrome, perihilar infiltrates."
Patient presented to the ED via EMS with complaints of nausea and vomiting. Had COVID vaccine on 4/15/21 at 0900. Felt well until 4/17/21 evening when she developed severe dizziness, nausea, and vomiting. Described as "room spinning" senation, which worsened with turning her head. Denied any weakness, abdominal pain, shortness of breath, chest pain, or other symptoms. She was treated with IV fluids, antiemetics, lorazepam, and meclizine. This morning she reports dizziness is much improved, though not resolved. Continues to deny chest pain, shortness of breath, headache or other symptoms. Nausea and vomiting have resolved.
Pt recvd 3 doses of Engerix B w/ the 3rd dose given Oct91. Pt did not repond & was seen by employee hlth MD. Given 4th dose Oct91.
This case was reported by a pharmacist via call center representative and described the occurrence of generalized rash in a 72-year-old male patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In June 2018, less than a day after receiving SHINGRIX, the patient experienced generalized rash, skin ulcer, influenza-like symptoms, headache and fever. In June 2018, the outcome of the generalized rash, skin ulcer, influenza-like symptoms, headache and fever were recovered/resolved. The reporter considered the generalized rash, influenza-like symptoms, headache and fever to be possibly related to SHINGRIX. It was unknown if the reporter considered the skin ulcer to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received the SHINGRIX on an unknown arm. The patient experienced a whole body rash with open sores, flu-like symptoms, headache and fever within 1 day after receiving the SHINGRIX. All the events were resolved within approximately 1 week without treatment. The healthcare professional (HCP) was not in the pharmacy at the time of report, and was not able to provide additional information.
This spontaneous report as received from a pharmacist refers to a 46 year old male patient. On an unspecified date in June 2013 the patient was vaccinated with the first dose of GARDASIL (lot# unspecified). No adverse symptoms reported. The outcome of the report was unknown. Additional information has been requested.
hospitalized 9/21/21 with generalized weakness, confusion and poor p.o. intake. SARS-COV-2 positive.  Noted to be hypoxic on ABG.  However not noted to have pneumonia on CT angiogram and did not have a PE.   PMH ITP, T2DM, history of follicular thyroid cancer, status post thyroidectomy, history of malignant melanoma and history of pituitary adenoma.
Physician mixed ActHIB with a sterile diluent instead of the one that comes with ActHIB, no AE; Initial information received on 11-Oct-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 2 months old patient who received 0.5 ml first dose of vaccine HIB (PRP/T) VACCINE [ACT-HIB] (lot number and expiry date not reported) which was mixed with a sterile diluent instead of the one that comes with ACT-HIB, via intramuscular route in right thigh on 10-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history and concomitant therapies were not provided.   It was a case of actual medication error due to wrong solution used in drug reconstitution.  At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
This spontaneous report was received from a medical assistant, concerning an unspecified number of patients of an unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 06-SEP-2017, 21-SEP-2017 and 27-SEP-2017, the patients were vaccinated with improperly stored doses of VARIVAX with lot # M027344 with expiration date on 06-JAN-2018 (strength, dose, route of administration, and anatomical location were not provided) which were reconstituted with properly store sterile diluent (manufacturer unknown). The storage temperature was reported as 15 to 46 degrees Fahrenheit (°F) (14.5 °F) for an unknown time frame. Regarding the temperature excursions, it was reported that since 05-SEP-2017 to 02-OCT-2017, the doses of VARIVAX with lot # M027344 were exposed to storage temperatures from 5.5 to 17.5 (°F) and the maximum time frame of exposure was reported as 1 hour 45 minutes. No adverse effects were reported. No product quality complaint (PQC) was involved.
I had a EKG which determined I had palpitations. I was put on a 24 hour monitor.
Bruising and redness at injections site on right thigh.  Discovered on 7/9/20, when pt was in the office 1 week after vaccine administration.  Pt had not c/o pain or discomfort to his mother.  While in office, the site was washed with Hibiclens and hydrocortisone ointment and an Op-site were applied.
face was beginning to turn red; Developing urticaric rash; Rash quickly spread to lower abdomen, up trunk to arms and neck; This spontaneous case was reported by a nurse and describes the occurrence of ERYTHEMA (face was beginning to turn red), URTICARIA (Developing urticaric rash) and RASH (Rash quickly spread to lower abdomen, up trunk to arms and neck) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 007M20A and 037K20A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19.    Past medications reported as adhesive and latex with allergy as an reaction.  Previously administered products included for Drug use for unknown indication: doxycycline. Past adverse reactions to the above products included Allergy NOS with doxycycline. Concurrent medical conditions included Migraine, Polycystic ovarian syndrome, Restless leg syndrome, Dysmenorrhea, Scoliosis and ADD.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (Oral) at an unspecified dose. On 25-May-2022 at 12:00 PM, the patient experienced ERYTHEMA (face was beginning to turn red), URTICARIA (Developing urticaric rash) and RASH (Rash quickly spread to lower abdomen, up trunk to arms and neck). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 50 milligram. At the time of the report, ERYTHEMA (face was beginning to turn red), URTICARIA (Developing urticaric rash) and RASH (Rash quickly spread to lower abdomen, up trunk to arms and neck) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported.  The patient had received COVID-19 vaccine previously.
arm is extremely red and is swollen in a large area around the injection site.   It is warm to touch.  Patient noticed right after injection was given,
2 days p/vax pt arm became red, sore & swollen; pt put on ATB as MD treating thought could be cellulitis or urticaria;
Information has been received from a healthcare worker concerning a 36 year old female employee who 2 weeks ago on approximately 27-FEB-2008 was vaccinated SQ with 0.65 "mg" of zoster vaccine live (Oka/Merck). Subsequently, on approximately 27-FEB-2008 (th past two weeks) the patient experienced a red, itchy rash over her whole body with no lesions. She also had a headache, nausea and vomiting. Medical attention was sought in the office on 12-MAR-2008, the patient was seen by the nurse practitioner. She was treated with ATARAX for itching. The nurse practitioner did not feel this was related to the vaccine. The rash did not resemble chickenpox or shingles. At the time of the report the patient had not recovered. VZVIP offered but there was no lesion, the rash had no opened areas.   Follow-up information from the nurse practitioner indicated that the patient was evaluated in a local emergency room and was diagnosed with chickenpox. The nurse practitioner stated lab testing was not involved in the diagnosis of this varicella rash. The diagnosis was based upon the patient's symptoms which were described as a rash which was "macular, papular and vesicular" associated with itching.   Follow-up information received has been form a nurse practitioner concerning this 36 year old female registered nurse who on 26-FEB-2008 was vaccinated in the left arm with zoster vaccine live (Oka/Merck) (lot # "10794"). Subsequently, on 12-MAR-2008 the patient developed itching, a rash and headache. The patient also felt nauseated and had general malaise. Medical attention was sought in the emergency room. According to the ER report the patient had macular papular vesicular lesions on her trunk and chest. At the time of the report the patient's status was unknown.  Follow-up information from the nurse practitioner indicated that she was not seeing this patient. She did not know if the patient had recovered.   Additional information is not expected.
About 10  minutes after receiving the vaccination, the patient's significant other came to the pharmacy counter where the pharmacist was assisting another patient and stated that the patient said she wasn't feeling well and then fainted. She was seated and slightly slumped to her side.  The pharmacy went out of the pharmacy to check on her and upon approach, the patient awoke, confused. She felt very warm to the touch with a light sweat on her forehead. She was able to respond and didn't have recollection of fainting. She agreed to the offer of an ice pack, which she was directed to hold to her head. The partner sat with the patient while the pharmacist had to briefly assist another customer. Then the pharmacist sat with the patient while their partner purchased water and crackers. The patient stated she had hardly eaten all day and had been anxious prior to the vaccine because she has a fear of needles. Within minutes she felt better and declined the offer to call EMS for assessment. She stayed at least an additional 10 minutes before leaving the pharmacy.
This spontaneous report as received from a physician refers to a male patient in his late 60's with no pertinent medical history and no drug reactions or allergies. In October 2013, reported as about five and a half weeks ago, the patient was vaccinated with a dose of ZOSTAVAX injection, subcutaneously (dose and lot number not provided). On 31-OCT-2013 reported as three weeks ago, after receiving ZOSTAVAX the patient noticed a rash and saw his primary care physician who diagnosed patient with shingles. The patient was advised by his primary care physician to go to an unspecified hospital, in which he was admitted for a few days. A treatment at this hospital for the shingles was acyclovir therapy. While at the hospital, the patient had unspecified blood work drawn, which showed he was positive for leukemia. On 12-NOV-2013 the patient was transferred from the unspecified hospital to other hospital to treat the leukemia. The physician noted that when the patient arrived on 12-NOV-2013 the patient's lesions were crusted and unspecified blood work was drawn. The physician reported that the patient had bacteria in his blood, which probably developed from the shingles. The patient was put on an unspecified antibiotic. The physician stated that the patient was not being treated for leukemia, rather they were waiting for the sepsis to clear up. Upon the physician review because of the events the patient had a significant disability and the sepsis was a life threatening event. Upon internal review the leukemia and sepsis were considered to be serious as other medically significant events. The outcome of the patient was reported as not recovered. The patient relatedness between vaccination with ZOSTAVAX and events was not reported. Additional information has been requested.
Pt developed raised red rash flexal area with pruritus of the arms, palms soles about 8 hours after administration of vaccine. Then developed mild pharyngeal swelling all SX resolved with self TX with Benadryl.
This spontaneous report as received from a consumer concerning his 4 years old female daughter who on an unspecified date was vaccinated with (Merck) VARIVAX (dose, route and lot # not provided). No other co-suspects were reported. No concomitant medications were reported. The consumer stated that his daughter on an unknown date had unusual side effects after her immunization with (Merck) VARIVAX follow up and shot and now had a mild case of chicken pox. However, she was still turning up new spots on her back and waist even though her first blisters showed up roughly 2.5 weeks ago. Her symptoms otherwise have been mild, roughly 20-30 spots in all. No treatment information was reported. The outcome of the events mentioned above was unknown. The relatedness for the events was unknown for (Merck) VARIVAX. Additional information has been requested.
Rash (almost blister) on upper arm on either side of injection site.   Still mark and small bruise today March 4, 20121
Symptom start Sunday morning, severe aching "toothache type" of pain but no redness or visual sign, pain from neck to elbow and tingling fingers. Pain has not abated with Ibuprofen 800 mg. Pt follow up with ER visit on 9/27/18.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Pertinent medical history and concomitant medications were unspecified by reporter. On 26-DEC-2014 the patient was vaccinated with a dose of GARDASIL (lot # J011272, expiry date: 21-APR-2016, dose, route of administration and anatomical location was unknown) which was improperly stored. No adverse effect reported. The outcome of the event was unknown. Additional information has been requested.
Post vaccine day 7, "quarter-size" red area; on day 8, approx. 3 inches in diameter, red, warm, slightly tense, itchy. No lymphadenopathy, no fever. Telehealth visit
Day 1 - Tingling, itchy mouth Day 2 - nerve tooth pain started Day 3-6 - excruciating nerve pain Day 7-14 - rash, diagnosed Shingles Day - 14-19 ear pain - ear infection Day 28 - nerve sensations still present
Pt's dad "forgot" son's date of birth at time of first dose and gave DOB of his daughter instead.  Gave us the wrong date of birth.  Did not discover this till patient came into pharmacy for 2nd dose.  At the time of first dose patient was 11 years old.  Patient report no adverse reaction to the first dose.
Vaccination site lump; Injection site bruising; Injection site redness; Injection site bleeding; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Vaccination site lump), INJECTION SITE BRUISING (Injection site bruising), INJECTION SITE ERYTHEMA (Injection site redness) and INJECTION SITE HAEMORRHAGE (Injection site bleeding) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and Psoriatic arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) CF. On an unknown date, the patient experienced VACCINATION SITE MASS (Vaccination site lump), INJECTION SITE BRUISING (Injection site bruising), INJECTION SITE ERYTHEMA (Injection site redness) and INJECTION SITE HAEMORRHAGE (Injection site bleeding). At the time of the report, VACCINATION SITE MASS (Vaccination site lump) was resolving and INJECTION SITE BRUISING (Injection site bruising), INJECTION SITE ERYTHEMA (Injection site redness) and INJECTION SITE HAEMORRHAGE (Injection site bleeding) had not resolved.            Concomitant drugs not reported. There was no reported medical history. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. For HUMIRA, the reporter causality for the event of Vaccination site Lump reasonable possibility and the reporter causality for the events of Injection site bruising, Injection site redness and Injection site bleeding was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. Treatment drugs not reported.   Reporter did not allow further contact
Pt recvd Hep B vax series & it was determined that pt was not protected; Pt recvd 2nd Hep B vax series & is still not protected;
Heavy period and prolonged bleeding/fatigue off and on since Moderna;  continues to get worse with no relief.
Child recieved child's 5-11 Pfizer first. Realized during documentation that wrong dosage was given. Parent notified of wrong dose given and child recieved correct doseage immediately. Both doses documented.
PT was administered the Pfizer COVID-19 vaccine at 11:10am and waited with wife and daughter in the designated waiting area. They walked to the store entryway to leave at 11:30am and Pt complained of nausea. His daughter brought him a garbage can; he retched into it twice without vomiting. He then arched back and started seizing. He was seated in a walker at the time, went very pale and seized for approximately 30-40 seconds. Emergency services were contacted by store personnel. We laid him down on the ground to decrease his fall risk. Approximately 5 minutes later he was verbal and responsive. EMS arrived and took over. I informed them of his vaccination and daughter relayed his health history. EMS then took patient to preferred hospital for evaluation.
Patient had syncopal episode w/ convulsions. Took prolonged time to recover. Emesis x 2. Taken to ED.
Extremely tired kept falling asleep all day of shot; slept thru the night and most of next day; hives on left side of neck (received shot in left arm) diarrhea all day after shot; arm slightly sore.  Did not feel sick; just had these reactions.
Patient received Vaccine Booster (Dose 3) which had hindsight was expired past 10 weeks in refrigerator temperatures.  (19 days Past date Expired 4/11/22) Called Patient 5/13/22 did not experience side effects. Not seeking revaccination.