chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax 2MAY97 & 2MAY97 pt vomited @ 3PM & 2hr later devel a gen urticarial rash from head to toe;this progressed w/in 5min to individual raised, red bumpy lesions which lasted 3 days & swelling of the hands which lasted one day;limpnes
20MAY92 pt recvd MMR/DTP/OPV/HIB & 29MAY92 fever 103 ax-seizure-IV Phenobarb-observation in ER for several hrs; 1JUN92 continues to run low grade fever-keeps falling down-loss of balance;
That evening, chills, low-grade fever at about a 100 degrees, bad muscle aches. Ended at just about 8pm the next day. Weird surreal dreams since receiving the shot and just had another one.
Coldness below knee-both lower extremities; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL COLDNESS (Coldness below knee-both lower extremities) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20?- either 4 or a 9) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced PERIPHERAL COLDNESS (Coldness below knee-both lower extremities). At the time of the report, PERIPHERAL COLDNESS (Coldness below knee-both lower extremities) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.; Sender's Comments: This case concerns a 60-year-old female of unknown age with NS unexpected event of coldness below knee in both lower extremities (Peripheral coldness).  Event onset the same day as the first dose of mRNA-1273. Treatment not reported. Event outcome unknown. 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.
Swelling and redness spreading around site of MMR injection right upper arm, 14 cm diameter redness at time of visit, 24 hours after injection.
Patient had & has been having syncope episodes since the first HPV vaccine given. HPV 8-10-2007, 9-13-2011, 10-20-2011.
client received 2nd dose covid vaccine Pfizer instead of Moderna. Per client to symptoms at time, observed 30 mins, gave ER precautions.
Six days post vax, pt developed a fever of approximately 103F and a large injection site reaction which was warm to the touch.  Pt was treated with application of ice and Benadryl and subsequently recovered.
Information has been received from a physician concerning an 8 year old female who on 14AUG1997 was vaccinated with a second dose of varicella virus vaccine live. On 10JAN2004, also reported as 12JAN2004, the patient was exposed to chickenpox and developed breakthrough. It was also indicated that the child developed varicella disease. The case of breakthrough was moderate. The child was covered with lesions, more than 50. Treatment was calamine lotion. No other information was available. Unspecified medical attention was sought. There was no product quality complaint. No further information is expected.
Patients were administering 0.25 ml instead of 0.5 ml to uncompromised adults/approximately 100 patients were administered lower than authorized dose of the Moderna COVID-19 bivalent booster; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patients were administering 0.25 ml instead of 0.5 ml to uncompromised adults/approximately 100 patients were administered lower than authorized dose of the Moderna COVID-19 bivalent booster) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patients were administering 0.25 ml instead of 0.5 ml to uncompromised adults/approximately 100 patients were administered lower than authorized dose of the Moderna COVID-19 bivalent booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patients were administering 0.25 ml instead of 0.5 ml to uncompromised adults/approximately 100 patients were administered lower than authorized dose of the Moderna COVID-19 bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patients were administering 0.25 ml instead of 0.5 ml to uncompromised adults/approximately 100 patients were administered lower than authorized dose of the Moderna COVID-19 bivalent booster).    No concomitant medications were reported.   It was reported that, nurses had no standing orders other than what they had for the second booster, when first administering Bivalent boosters. So, they assumed the same dose as the second booster, hence they were administering 0.25 ml instead of 0.5 ml to uncompromised adults.  It was reported that approximately 100 patients were administered an invalid dose of the Moderna COVID-19 bivalent booster.  No treatment details were reported.
I have developed tachycardia, palpitations, and anxiety.  I am currently taking Alprazolam for the anxiety when needed and I am also taking Escitalopram daily to control panic/anxiety.  My body is no longer able to deal with high levels of stress.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    Concomitant medication was not provided. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 Vaccine. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
pneumonia; This spontaneous report was received from a lawyer referring to a female patient (pt) of unknown age. Information regarding current condition, historical condition or concomitant medication was not provided. On or about 15-JUN-2017, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, route, dose number, batch/lot# and expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered sharp intermittent left-sided chest pain radiating to her left shoulder and back and was diagnosed with pneumonia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not presented prior to using the vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the company's wrongful conduct, 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, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of pneumonia was considered as not recovered. The reporter considered pneumonia to be related to zoster vaccine live (ZOSTAVAX).   Pneumonia was considered as disabling. Upon internal review, pneumonia was considered as medically significant.
When covid vaccine guidelines changed. We were given incorrect information regarding dosing. Patient received lower than recommended dose. Parent notified and scheduled an appointment to receive correct dose.
In Monitoring area patient being observed when patient stated," I fell shaky and lightheaded.". Patient also verbalized that he was drinking an energy drink while waiting to get vaccinated and in need to urinate .Patient assessed  by RN and OCFD; continue to monitor for additional 15 minutes. Treatment:Patient was giving water to hydrate and use of restroom.Patient stated, " I feel fine and I am ready to go . I don't feel shaky or lightheaded anymore.". Patient left at 1:29pm
Extreme pain in arm of injection, entire arm throbbing, shooting pain in arm, neck and shoulder soreness and stiffness, difficulty using arm, especially when lifting.
Patient developed sudden onset flushing and edema of extremities in addition to hives on his lower back. Event occurred several minutes after administration of vaccines. He received 12.5 mg of Benadryl and had improvement in symptoms.
PATIENT REPORTED THAT NEXT DAY SHE BROKE OUT IN RASH AND COMPLAINING ABOUT ITCHING ALL OVER THE BODY
Narrative:  Patient admitted to hospital with change in mental status. COVID-19 +, but with multiple co-morbidities and other potential causes including current UTI. Patient recovered, discharged back to assisted living facility. PRINCIPAL DIAGNOSIS: 1. Acute Metabolic Encephalopathy, suspect related to acute infection/polypharmacy (drug induced , Trazodone + Quetiapine)vs progression of dementia 2. Acute UTI : with Proteus Mirabilis:s/p completed treatment 3. Acute Electrolyte Disorders: Hypokalemia ,Hypophosphatemia and Hypomagnesemia (corrected) 4. Self Care Deficiency/Failure to Thrive 2/2 advanced dementia 5. COVID + asymptomatic with h/o Prior infection and COVID Vaccination 6. Moderate Protein calorie malnutrition (30lb weight loss since 1/2021):BMI : 16% SECONDARY DIAGNOSES: Advanced dementia w behavioral changes on multiple meds- fluoxetine/seroquel/trazadone at group Home with no behavioral disturbance noted inpatient,noted insomnia Chronic BPH Bilateral Ischial Ulcers from Decubitus (POA) Chronic Hypertension : BP has been adequate off BP meds H/O GERD
Vaccination site reactions; Still feels the shot on the right arm/ had reactions with pain at injection or muscle; Low grade fever; Has pain under her arm by the ribs and on the bottom side of the arms and muscles/ Only thing weird this time was that under the arm by the ribs was muscle soreness; Tiredness; Chills for 18 hours; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Vaccination site reactions), VACCINATION SITE PAIN (Still feels the shot on the right arm/ had reactions with pain at injection or muscle), CHILLS (Chills for 18 hours), PYREXIA (Low grade fever) and MYALGIA (Has pain under her arm by the ribs and on the bottom side of the arms and muscles/ Only thing weird this time was that under the arm by the ribs was muscle soreness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A, 026L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included RIVAROXABAN (XARELTO) for Clot blood, MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Vaccination site reactions), VACCINATION SITE PAIN (Still feels the shot on the right arm/ had reactions with pain at injection or muscle), CHILLS (Chills for 18 hours), PYREXIA (Low grade fever), MYALGIA (Has pain under her arm by the ribs and on the bottom side of the arms and muscles/ Only thing weird this time was that under the arm by the ribs was muscle soreness) and FATIGUE (Tiredness). The patient was treated with IBUPROFEN for Adverse event, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE REACTION (Vaccination site reactions), VACCINATION SITE PAIN (Still feels the shot on the right arm/ had reactions with pain at injection or muscle), PYREXIA (Low grade fever), MYALGIA (Has pain under her arm by the ribs and on the bottom side of the arms and muscles/ Only thing weird this time was that under the arm by the ribs was muscle soreness) and FATIGUE (Tiredness) outcome was unknown and CHILLS (Chills for 18 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-383406 (Patient Link).
diagnosed with Covid-19, it was after the first dose of Shingrix; This case was reported by a pharmacist and described the occurrence of covid-19 in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced covid-19. On an unknown date, the outcome of the covid-19 was unknown.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was captured as adult as per the vaccine indication. The age at vaccination was not reported. After receiving Shingrix, the patient was diagnosed with Covid-19. At the time of reporting, the patient wanted to receive 2nd dose. The reporter consented to follow up.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX, intramuscularly (dose, lot number and expiry date were not reported) for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
This initial non-serious case, was received on 27-Sep-2017, from other health professional, concerning a 34-year-old, female, adult patient. The patient's medical history included first flu shot on an unspecified date and concomitant medications were not reported. On 19-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, batch number: 00444611A, expiry date: Jun-2018, route of administration, anatomical location: not reported). On 19-Sep-2017, 2.5 hours after vaccination, the patient complained of redness, itching on forearms and chest, noticeable hives. The patient recovered from the events on 20-Sep-2017. The reporter assessed the events as non-serious. Non-significant case correction received with IRD on 27-Sep-2017: The description as reported of the event was changed from "after receiving AFLURIA QUADRIVALENT patient complained of redness [and itching on forearms and chest and noticeable hives]" to "patient complained of redness [and itching on forearms and chest]" and "after receiving AFLURIA QUADRIVALENT' verbatim was removed from the description as reported from all the events.
Perfectly normal blood work November 2020. Now diagnosed with Pancytopenia with critically low RBC,WBC, & Platelets
pt exp acute pain, swelling & redness @ site of inj to thigh; fever of 103.5, leg was stiff & pt refused to put weight on leg; rxn occurred the same evening;
pt admitted to hosp with full body rash; A Fib with pacemaker; on ABX; no SOB; believed to be a drug rash; rash treated; during hospitalization pt tested positive for COVID; initially respiratory status and O2 requirement stable on 2-3 L O2; pt started to worsen; limited po intake; condition continued to decline; refused NG tube; pt passed away in the hospital
Irregular menstruation not otherwise explained by early menopause. I?m always have a very regular cycle and it became erratic after receiving the vaccine. With my cycle going from 27-28 days to anywhere from 10-23 days.  Also very heavy clotting and menstrual pain. Have never expelled clots in such a manner other than after childbirth.  I do get cold sores, usually about once sometimes twice a year. I?ve had four since the vaccine.  Sharp pain in my right ear not otherwise explained by infection and not present prior to vaccines. Feels like an ear ache: comes and goes.
Nurse gave injection over acromion.  Severe pain for three days so far.  Constant stabbing 10/10 pain for first 48 hours.  Little improvement.
Saturday my right eye was giving jabbing pains,. Since Monday my right eye and cheek are swollen with in a lot of pain
Shot hurt alot when given. Entire upper arm very sore for two days. Thurs. morning at 6:50am bitter taste in my mouth for two days. Thurs. slept on and off all day. Very unlike me. Dizzy had to be very careful when I did go back to bed..  I did put an ice pack on my arm but it did not seem to help to relive the pain.  Shot given to high on my arm.  I did not go to a dr. I had no one to drive me.
pt recv vax 9FEB98 & outbreak of chickenpox @ school;devel lesions 16JUN98 30 lesions trunk, legs, arms, face;
Pulsation tinnitus.  I hear it mostly in the early morning and evening.  It sounds like a guitar strumming vibration  in my left ear.
Extreme muscle pain and spasms throughout body 23 weeks pregnant 2 days, history or preterm birth estimated due Date December 27,2021
30 minutes after vaccine administered patient's supervisor called and spoke w/RN and said patient was diaphoretic, nauseous and vomiting. RN advised patient be taken to the Emergency Dept.
Upon the onset of receiving the Moderna booster, i experienced a rushing feeling immediately overtaking my head/brain area that felt incredibly warm and uncomfortable, accompanied by a rapid heart rate. The second day of the booster series was extremely tough, accompanied with extreme flu like symptoms, including chest pain and tightness. Since receiving the booster shot on November 28, I have experienced bouts of uncontrolled anxiety and panic attacks, in addition to periods of intense rapid heart rate (tracked by my  Watch). I am experiencing daily bouts of dizziness, which feels like vertigo, and have difficulty controlling my heart rate when standing up too quickly. Often times, when standing up too quickly (only since 11/30/2021) i experience the corners of my eyes going dark, as if i am going to lose consciousness. There are periods of extreme confusion and disorientation. I have been to the emergency room, who did not take my concerns seriously as they stated they were overwhelmed with real COVID patients, and a cardiologist who requested i have an ECHO done, but was not able to perform the test until January 5.
Client called to report reaction. She noted a area that is warm, red, and itchy with slight swelling to her left arm, directly over site of vaccine administration. She denies any breathing or swallowing issues. No rash noted to the area or elsewhere. Takes Zytec daily for seasonal allergies. OTC self-care recommendations given per medical Mgmt.
late noc 28APR98 pt c/o pain in neck & shoulder on rt side that cont radiated to lt side of body;rt arm was painful & red;pt c/o fever & chills w/inc BM's (not diarrhea);went to hosp  30APR98 & ER dx sever tetanus rxn;pt also had pain neck
pt woke up 19MAR97 crying-running temp 100-100.5;wednesday MN-present time 21FEB97-noon) @ thigh swollen (3" x 2") & red warm to touch;given APAP;pt seen by MD; no tx initiated;
Shooting arm pain since time of injection. Was treated twice for this, once at urgent care and once at your doctors office. Was given lidocaine injection at urgent care and kenalog at dr office. No relief from those treatments.
Sudden, unilateral sensorineural hearing loss developed 02/28/2021 0630..  Oral prednisone taper, trans-tympanic steroid injection.  No improvement in hearing to date.
Myocarditis, I had several chest pain, numbness in my left side and my tongue was heavy. I went to ER and my Troponin was at 16.5. I was admitted and got a Catheterization done, Heart MRI and among several labs. My blood pressure was low.
swelling in the lower part of his eyes; rash on his whole body; face swollen, red and hard; face swollen, red and hard; pain in the arm and a little body ache; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (face swollen, red and hard), ERYTHEMA (face swollen, red and hard), EYE SWELLING (swelling in the lower part of his eyes), RASH (rash on his whole body) and MYALGIA (pain in the arm and a little body ache) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Cardiac disorder.    On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jun-2021, the patient experienced MYALGIA (pain in the arm and a little body ache). On 26-Jun-2021, the patient experienced SWELLING FACE (face swollen, red and hard), ERYTHEMA (face swollen, red and hard) and RASH (rash on his whole body). On an unknown date, the patient experienced EYE SWELLING (swelling in the lower part of his eyes). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. On 26-Jun-2021, MYALGIA (pain in the arm and a little body ache) had resolved. At the time of the report, SWELLING FACE (face swollen, red and hard), ERYTHEMA (face swollen, red and hard), EYE SWELLING (swelling in the lower part of his eyes) and RASH (rash on his whole body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included high blood pressure medication, for cardiac problem.  Treatment information included steroid pills.
I woke up with a skin irritation all over my body. Patches on my arms, legs, chest, back, and scalp where it was itchy and the skin became instantly red after I scratched it. I took an anti-histamine once a day (Zyrtec) but it didn't have any real affect. The irritation seems to have mostly gone away on its own. This has never happened to me before. I visited my doctor and she recommended that I document this reaction.