chrisvoncsefalvay/vaers-outcomes huggingface dataset:
passed out; Fainted; hit his head; headache; tired; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) and SYNCOPE (Fainted) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), SYNCOPE (Fainted) (seriousness criterion medically significant), HEAD INJURY (hit his head), HEADACHE (headache) and FATIGUE (tired). At the time of the report, LOSS OF CONSCIOUSNESS (passed out), HEAD INJURY (hit his head) and HEADACHE (headache) had resolved and SYNCOPE (Fainted) and FATIGUE (tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Relevant concomitant medications were not reported.  It was reported that 24 hours after 2nd shot of vaccine patient was passed out and hit his head. He had weird headache before passing out. He was tired and fainted. Patient was transported to the hospital on Feb-2021.  Treatment information was not provided.  Company Comment: This is a spontaneous case concerning a 77-year-old male patient with no reported medical history, who experienced the unexpected, serious (medically significant) events of Loss of consciousness and Syncope. 24 hours after receiving a dose of mRNA-1273 vaccine (second COVID-19 vaccine) the patient passed out and hit his head. The patient had weird headache before passing out. The patient was tired and fainted and was transported to a hospital. Clinical course, diagnostic tests and treatment details were not provided in the case. At the time of the report, the event Loss of consciousness had resolved while the outcome of the event Syncope was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 08-Dec-2022: Added new events.; Sender's Comments: This is a spontaneous case concerning a 77-year-old male patient with no reported medical history, who experienced the unexpected, serious (medically significant) events of Loss of consciousness and Syncope. 24 hours after receiving a dose of mRNA-1273 vaccine (second COVID-19 vaccine) the patient passed out and hit his head. The patient had weird headache before passing out. The patient was tired and fainted and was transported to a hospital. Clinical course, diagnostic tests and treatment details were not provided in the case. At the time of the report, the event Loss of consciousness had resolved while the outcome of the event Syncope was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Vertigo, vomiting, started 3/31/2021 Left facial numbness and asymmetry (Bells Palsy) started on 4/7/2021. Treated with acyclovir and prednisone. Clinically symptom is improving.
Significant fatigue and leg pain noted the night after vaccines, patient unable to walk, constantly fussy/sleepy Seen in office the next day, exquisitely tender, unable to bear weight on legs. Family had been underdosing Tylenol/Ibuprofen. Given high rates of flu, we treated for flu despite testing flu negative (thought it may be myalgias). Patient had negative tests for rhabdomyolysis Seen 2 days later - No Tamiflu given, complete recovery to normal self with increaseing Tylenol/Ibuprofen dose.
Patient had sudden shortness of breath. Ambulance documented severe hypoxia. ER did CT scan of chest which showed flash pulmonary edema. Admitted for two days in hospital. Echo showed EF 39%. Troponin mildly elevated. WBC elevated to 23,000. Diagnosis is myocarditis and cardiomyopathy due to COVID vaccine.
While in monitoring area after receiving vaccination client reported hoarse voice, redness, swelling, and tingling of tongue and lips. Redness was in face, chest and right arm. Client denied difficulty breathing or throat tightness. Client reported at this time "significant hx of anaphylactic reaction." This was not noted clearly on screening form signed by client. Client given 50 mg Benadryl per standing order due to symptoms. Epinephrine was not given. 911 was called. Client vitals remained stable with slightly elevated blood pressure ate 140/102. EMS arrived before repeat vitals were taken. Lung sounds were clear and equal bilaterally. Report was given to EMS and care transferred.
Product leaked out from the back of the barrel with no adverse event; Product leaked out from the back of the barrel onto her hands and the floor with no adverse event; Initial information received on 05-Oct-2021 regarding an unsolicited valid non-serious case from an other health care professional (under the reference 00798927).  This case involves a 30 year old female patient who had INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] leaked out from the back of the barrel (device leakage) and onto her hands and the floor (exposure via skin contact).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 05-Oct-2021, the patient received a dose of suspect FLUZONE HIGH-DOSE QUADRIVALENT (lot UJ764AC and expiration date: 30-jun-2022) via unknown route in an unknown administration site for prophylactic vaccination  It was an actual medication error due to device leakage and exposure via skin contact (same day latency).   At time of reporting, the outcome was unknown for the reported events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
Injection was administered too high in shoulder. Severe shoulder pain, with limited swelling.  Orthopedist diagnosed shoulder impingement as a result of inflammation from poor shot administration.
Pfizer-BioNTech COVID-19 Vaccine EUA Injection site pain - started 1hr after shot, lasted for 2 days Tiredness - started 4 hr after shot, lasted for 2days Headache - started 1.5 hours after shot, lasted until next day morning Fever - started morning of the day after shot, lasted until same day evening
Outbreak of rash all over body, causing rough, flaky skin; itchy, burning eyes. Neither antihistimine tablets nor eye drops provided any relief.
tenderness, redness, and the arm was swollen/3 cm wide 5 cm long; tenderness, redness, and the arm was swollen; it's a little bit firmer than the rest of the arm; tenderness but past away; A spontaneous report was received from a healthcare professional concerning a 70 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events left arm on the deltoid muscle, did not noticed absolutely nothing, tenderness but past away, tenderness, redness, and the arm was swollen, 3 cm wide 5 cm long and it's a little bit firmer than the rest of the arm.  The patient's medical history was not provided. Concomitant medications reported were Supplements, Vitamins, Clariton for drug use for unknown indication.  On 02 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 041L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 2 Feb 2021, the patient experienced the event(s) left arm on the deltoid muscle, did not noticed absolutely nothing. On 3 Feb 2021, the patient experienced the event(s) tenderness but past away, tenderness. On an unknown date, the patient experienced the event(s) redness, and the arm was swollen, 3 cm wide 5 cm long, it's a little bit firmer than the rest of the arm  Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), left arm on the deltoid muscle, did not noticed absolutely nothing, tenderness but past away, tenderness, redness, and the arm was swollen, 3 cm wide 5 cm long and it's a little bit firmer than the rest of the arm was 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.
Pt reported "significant respiratory distress" that awakened him from sleep 8-10 hours after getting his flu shot.  He describes his symptoms as similar to past asthma attacks with wheezing, but had an unusual sensation of chest tightness  ..."almost like someone was standing on my chest."  Used albuterol inhaler - 2 puffs - and felt his symptoms improved enough to return to sleep.  Upon awakening in the morning, he had some remaining chest tightness and he was fatigued from disturbed sleep. He also minor body aches that improved.  + hx of childhood asthma that now is related to seasonal allergies, worse in spring.  Received allergy shots for 3 years, now on monthly maintenance.  Takes no meds except vitamin, fexofenadine prn for seasonal allergies, and albuterol inhaler prn.  Denies current allergy or asthma symptoms, hx of heart disease or a reaction to past immunizations of any kind. Does not get a flu shot every year, but has never had a reaction of any kind in the past.
Eye crust; This spontaneous case was reported by a non-health professional and describes the occurrence of EYELID MARGIN CRUSTING (Eye crust) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced EYELID MARGIN CRUSTING (Eye crust). The patient was treated with ERYTHROMYCIN at an unspecified dose and frequency. At the time of the report, EYELID MARGIN CRUSTING (Eye crust) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's medical history was not provided No relevant concomitant medications were reported Treatment details included Erythromycin was prescribed but patient did not take at the time of the call.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX (dosing details unknown, 19400 PFU), at another pharmacy. Concomitant medications were not reported. On an unknown date the patient experienced an injection site reaction. Outcome of injection site reaction was unknown. Causality assessment was not provided. Product quality complaint was not involved. Additional information is not expected since follow up to this report was declined and no additional information was provided.
Information has been received from a health professional concerning a 17 year old female who on 15-JAN-2008 was vaccinated with the first dose of GARDASIL and experienced hives on the face and neck. As of 16-JAN-2008, the patient was recovering. Follow-up information was received from the physician's assistant who reported that the rash was probably due to exposure to something else and not related to GARDASIL.
pt was irritable with high-pitched screaming, for 2 hrs p/shots given; pt was seen @ hosp ER that evening; exam nl;
Pt came to the pharmacy a few days after the administration of the vaccine with the concern that she had painful and swelling right arm when the vaccine was administered. The pharmacist on duty examined her right arm. It was red and warm on touch. Pt was advised to take TYLENOL (acetaminophen) 500 mg tablets three times a day as needed and also to apply cold compress on her arm. A week later, pt came to the pharmacy and the pharmacist examined again. Her right arm is no longer swelling nor red and the pain subsided, but pt had concern that there was a small bump inside her right arm where the vaccine was administered. There was also some scaling skin on certain area of her right arm when vaccine was administered. Pt was advised to apply a moisturizing cream (EUCERIN or CERAVE) two to three times a day on that skin area. A few days later on 08/10, pt came to the pharmacy again. The pharmacist examined her right arm, the scaling skin improved but the small bump inside the right arm could still be filled. Pt wanted to file VAERS report. Pharmacist already explained to her what VAERS and what did it mean to her.
The first day I was extremely tired I couldn't get out of bed, I felt really dizzy, my neck was stiff. That lasted for about a day. On 08/14/2021 my neck got stiff again, it kept lifting up, my eyes would get stuck looking upward. I also had diarrhea, vomiting, overheating, nausea, headache, fatigue.
Within one hour very large double bruises on upper arm slightly below injection site.  At 1.5 hours headache that was incapacitating as well as nausea, weakness and double vision.  Inability to eat properly for about 21 days.  Headache continues to this day on a daily basis since it's start.  One large bruise still highly visible.  On injection arm frequent and random small blood vessels rupturing.  Chronic fatigue and unwell feeling.  Had to resign from full time job due to reduced ability to drive and perform general daily functions with any reliability.  Only able to work on days that I feel well enough to drive and function, around 2 half days per week in a normal week.
nosebleed for 4.5 hours; blood pressure was 218/170; left side ear also split on the outside and bled the next day; left side ear also split on the outside and bled the next day; This is a spontaneous report from a contactable consumer (the patient). This 41-year-old (non-pregnant) female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205), via an unspecified route of administration, administered in left arm on 05Mar2021 19:15 (at the age of 41-year-old) as single dose for COVID-19 immunization. Medical history included nasal polyps and high blood pressure. Concomitant medications included losartan (manufacturer unknown), loratadine (CLARITINE), mometasone furoate (FLONASE), amfetamine aspartate/ amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (ADDERALL) and ibuprofen (ADVIL); all were taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Mar2021 20:00, the patient experienced "nosebleed for 4.5 hours" requiring an emergency room visit and treatment of 'Rhino Rocket' (nasal packing kit). On 07Mar2021, her "blood pressure was 218/170". On an unspecified date in Mar2021, her "left side ear also split on the outside and bled the next day". The clinical course was described as follows: "my nosebleed was so bad that I had to go in an ambulance to the hospital. My blood pressure was 218/170.  All bloodwork was good, platelets/hemoglobins/etc. My nose bled for 4.5 hours. I had to get a 'Rhino Rocket' to stop the bleeding. I have never had a bloody nose like this before. I do have nasal polyps. A nurse I work with, who also has nasal polyps, had the same thing happen after her second dose. This happened to me 48 hours, to the hour, after my first dose. It was my left nostril and I had the first dose in my left arm. My left side ear also split on the outside and bled the next day. There was no cut. I did second dose, 31Mar2021, in right arm and had no reactions. I have had no issues since. I am a huge advocate of your vaccine." The clinical outcome of the events "nosebleed for 4.5 hours", "blood pressure was 218/170", and "left side ear also split on the outside and bled the next day" was resolved in Mar2021.
After my Pfizer vaccine I experienced a low grade temperature, bilateral leg and bone pain, insomnia , hot flashes, night sweats,  fatigue for 3 weeks, chronic cough, fatigue 3 weeks in duration, diarrhea, stomach pain, air hunger., anxiety. body pain. joint pain have gotten worst since vaccination.
Fever, chills, migraine headache for 1 day. I slept and laid with 3 blankets and a heating pad.
Within 24 hours of receiving vaccine I developed a temp of 102, as well as body aches and chills, On 4/3 had nausea pounding headache and loss of appetite, the above symptoms continued with the exception of fever.  Left leg pain and head pain increasingly got worse. On 4/8 i started get large bruises on my left leg down by ankle. Later that day a lump developed. On 4/9 lump moved to below knee cap. Went to Hospital on 4/9. Was treated and released. Came home rested and symptoms DID NOT IMPROVE,  went Back to Hospital on 4/13/2021 and was admitted. Pain is worse in head and left side, toes on left foot were tingling unable to stand for more than 5 min, chest pain . Released following day and was advised to contact CDC. Still in pain and have horrible headache and mass is still visible on left leg, left leg is still hurting
Narrative:  Per June 25 2021 Palliative Care note "85 y.o. male patient with h/o Bladder ca s/p TURBT (5/2021), DM2 w/ retinopathy, OSA on CPAP, chronic PE, chronic HTN, periodontitis, nodular goiter, thyrotoxicosis, vit B12 def, severe hearing impairment s/p cochlear implant, OA, DDD lumbar spine, carpel tunnel syndrome, and shingles, who presented to the ED per PCC recommendations for worsening back pain, loss of appetite, and non-bloody diarrhea. He additionally endorsed significant wt loss over last year from 225 to 175 lbs, increasing fatigue. CT A/P in ED demonstrated liver mass vs adjacent adenopathy (incompletely visualized), new mild periaortic adenopathy, and new small nodules in the omentum and scattered in the mesentery concerned for additional adenopathy and/or peritoneal carcinomatosis. He was admitted for AKI, hyperkalemia, and back pain. Oncology has been consulted, discussed biopsy with patient, and recommended Palliative care consult to further discuss goals of care with the patient.." Pt then moved for hospice care and to be with family around 7/8/2021 per data system notes. pt then died on 7/30/21. Pt had received covid vaccinations on 3/12/2021 & 4/9/2021. Vaccinations not related to pt's death.
COVID breakthrough case. The patient had difficulty breathing on 11/13/21 and thus presented to the hospital. She was COVID positive on 11/13/21. She is on high flow oxygen in the hospital currently.
tiredness; fever; stomach; This case was reported by a consumer via (Shingrix interactive digital media and described the occurrence of tiredness in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th September 2021, the patient received Shingrix. On 9th September 2021, 1 days after receiving Shingrix, the patient experienced tiredness, fever and stomach pain. On an unknown date, the outcome of the tiredness, fever and stomach pain were unknown.   It was unknown if the reporter considered the tiredness, fever and stomach pain to be related to Shingrix.  Additional details provided were as follows: The reporter was the daughter of the patient. Age at vaccination was not reported. The patient received the the Shingrix shot and at the time of reporting experienced the common side effects of tiredness, stomach, and fever. The reporter asked how long will these side effects will last. Follow-up would not be possible as no contact details available.
2wk post vax pt exp t103, dizziness, rash (face/arms, back stomach);neck glands swollen, h/a
A little redness and itchiness near injection site; A little redness and itchiness near injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 2022, outcome "unknown" and all described as "A little redness and itchiness near injection site". Additional information: A little redness and itchiness near injection site after COVID vaccine bivalent booster.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
2 days after vaccine, pt developed a maculopapular rash. Rash started on right thigh, then both arms, then chest, abdomen, and back. Finally rash spread to neck, face, hands & feet (including palms & soles). Pt first seen for rash on 1/12/21, 4 days after the vaccine. Then seen again for follow-up on 1/14/21 after the rash continued to spread and get more red and diffuse on oral antihistamines and topical mild steroids. When seen 6 days after the vaccine, pt given oral steroids for 5 days. Has not been seen for follow-up to know outcome but did not go to the hospital over the following 4-day weekend.
This solicited report has been received from a 62 year old female patient who is enrolled in a Market Research Program concerning to an unspecified number of people. The patients' concurrent condition, historical conditions and concomitant medications were not reported. On an unknown date, the unspecified patients were vaccinated with doses of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route and anatomical location were not reported). The reporter stated that "many people" she knew were vaccinated and "it made them sick (malaise) and they still had the disease". The outcome of the event was reported as not recovered. The causality between the events malaise and vaccination failure and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) was reported as related. Additional information is not expected as the reporter did not consent for further follow up.
High fever peaking at 104, lasting roughly 12-18 hours. Motrin and Tylenol to reduce fever. Hives  on scalp, hands.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.   This case was linked to MOD-2021-395985 (Patient Link).