chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist concerning a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On unspecified dates in 2016, the patient was vaccinated with the first and second dose of M-M-R II, and on 04-MAR-2017, the patient was inadvertently vaccinated with a third dose of M-M-R II "single dose", subcutaneous route (dose, lot number and expiration date were not reported) for prophylaxis. No adverse effects were reported. A product quality complaint was not involved. Additional information has been requested.
Patient was administered Fluzone and immediately a tonic seizure. 01/16/07-records received afrom doctor and reviewed. Seizure immediately following a flu shot, body stiffened, eyes rolled back and she was unresponsive. Patient's uncle has history of tonic clonic siezure. Patient has had asthma in 2002 and is on Advair. EEG:11/10/06. MRI: No acute intracranial pathology.  02/16/07-records received and reviewed from Dr. for DOS 11/10/06. Physical exam WNL; Seizure (GT type) within few seconds. Had generalized tonic spasm of body all 4 extremities and moving of eyballs within few second of injection of vaccine. Became fully concious and responsive in 2 minutes. Did not void.
child age 12 yrs and 14 days recieved pfizer 5 to 11 vaccine dose 0.2 instead of 12 year pfizer.
COVID 19 Treatment.; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EL3247), on 26Feb2021 as dose 2, single (Lot number: EM9810) and on 30Oct2021 as dose 3 (booster), single (Lot number: 32030BD) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ESCITALOPRAM; TRAZODONE. The following information was reported: VACCINATION FAILURE (medically significant), outcome "not recovered", described as "COVID 19 Treatment."; COVID-19 (medically significant), outcome "not recovered", described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive for COVID using at-home antigen tests on Day 5; Positive, notes: Tested positive for COVID using at-home antigen tests on Day10. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient had taken anti-viral treatment of drug Paxlovid from 05Jul2022 to 10July2022 for the treatment of covid-19.  No follow-up attempts are possible. No further information is expected.
Pt recvd DTP/OPV 5NOV91 & ran temp between 102-104 5, 6 & 7NOV; pt brought to office 7NOV p/experiencing what appeared to be a febrile sz while in car w/grandma; examined in office t104; APAP given;
Two hours after receiving injection, I experienced onset of severe left shoulder pain and significantly decreased range of motion . This became worse over course of day. I was unable to sleep that night due to pain. I applied ice to site every 2 hours, along with ibuprofen 600 mg  every 4 hours, to little effect. The following morning I sought treatment at above urgent care site. I was diagnosed with vaccination arthropathy and given a 5 day course of steroids. The practitioner agreed that the injection was given "too high" on left arm, which caused my symptoms. My symptoms continue to improve, though I have only about 90% ROM in left arm now, along with mild pain.
This initial spontaneous case was received on 25-Oct-2017, reported by other non-health professional, concerning a female patient of unspecified age. The patients historical drug included Influenza vaccine. On an unspecified date, the patient was administered with INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, expiry date, batch number, manufacture and trade name: not reported). On unspecified date after administration of vaccine, the patient experienced cellulitis at the injection site. The patient was treated with unspecified antibiotics. The reporter assessed the event non-serious.
Information has been received from a licensed practical nurse concerning a 78 year old retired female with allergies to sulfonamides, codeine, BIAXIN, and CEFTIN, who on 11-OCT-2005 at 12:00 was vaccinated intramuscularly in the right deltoid with a second dose of Pneumovax 23 (lot # 650452/0753F). There were no illnesses at the time of vaccination. The patient stated that her arm started to feel uncomfortable before she left the physician's office that day. On 11-OCT-2005 the patient complained of irritation of the right arm with increased pain, redness and swelling which started in the area of injection. Her arm became very sore and she had difficulty raising her arm over her head. The patient tried to manage with ice and BENADRYL at home. The next day, the area was very swollen down passed the elbows and was reddened and tender. On 13-OCT-2005 the patient returned to the physician's office with severe upper arm pain and tenderness. She was diagnosed with an allergic reaction to Pneumovax 23. The patient was treated with a ROCEPHIN injection, ALLEGRA, ice and BENADRYL. The patient's symptoms lasted approximately 5 to 7 days. It was also noted that the patient had no problems with her first dose of Pneumovax 23. No further information is expected.
A spontaneous report was received from a healthcare professional concerning a 65-year-old, White, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, after the vaccines lost temperature they were administered.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 Jan 2021, a refrigerator in a vaccine clinic lost power and rose up to room temperature overnight. At approximately 9 p.m., the vaccines inside the refrigerator reached room temperature.  On 12 Jan 2021, after the vaccine lost temperature, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The event, after the vaccines lost temperature they were administered, was considered resolved on 12 Jan 2021.; Reporter's Comments: This case concerns a 65-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot number: 027L20A), reporting Out of specification product use.
When it was time to mix the diluent with the pfizer vaccine, I was reading through the instructions and I had an associate draw up the diluent. She drew up the correct amount of 1.8 ml and I checked it. As she was putting the diluent into the pfizer vaccine, a very small amount of the diluent spilled from the syringe and at the top of the needle. She put in the rest of the diluent and then we took the rest of what was left of the diluent and put it inside the the vaccine. When it was all mixed, it looked like we would have the correct amount. We withdrew 1 dose at a time with the correct amount. When we withdrew the the 4th dose, there was only a little bit left on the vial but not enough to give the 5th dose. I really thought there would be enough for 6 doses since we took the rest of the diluent that was left over and put it inside the vial which was 0.2 ml. I should of stopped what I was doing and called another associate for help. I will take this as a learning lesson and will be more diligent in the future.
Chills, Fatigue, left arm pain and fever of 100.3.  Treatment include Tylenol with no improvement at this time.
Headache started at 6am day following injection.  Developed fever of 102 day after injection, lasting over 24 hours.  Chills, body aches, fatigue, shortness of breath.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 30-Mar-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 30-Mar-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 30-Mar-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 30-Mar-2022) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2022 at 3:08 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 30-Mar-2022 at 3:08 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 30-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 30-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 30-Mar-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 30-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.  The patient received vaccine past its 30 day expiry date on 30-Mar-2022 at 3:08:45 PM. Vaccine went into 2 to 8 degree Celsius thaw state on about 24-Dec-2021. The vaccine was administered up until its manufacturing expiry date of 04-Apr-2022.
Red dots on torso (front and back), shoulders, arms, and upper thighs. Most red dots are flat, a few are raised and slightly itchy. Began 6 days after receiving first dose of Moderna vaccine.
immediate itching and burning over entire body.  Within 5 minutes had a pounding headache, light-headed, dizzy, and shortness of breath, hard time breathing.
Three and a half days after the vaccine experienced nerve pain in my legs. Went into the ER was admitted for observation. Is getting better day to day.
WITHIN SEVERAL MINUTES OF RECEIVING THE VACCINATION THE PATIENT PASSED OUT, REGAINING CONSCIOUSNESS WITHIN 1 MINUTE
Terrible headache/lingering headache; Body ache; Fatigue/tiredness; Slept on and off all day; sore arm at injection site with warmth, swelling and tenderness; sore arm at injection site with warmth, swelling and tenderness; sore arm at injection site with warmth, swelling and tenderness; This is a spontaneous report from a contactable nurse reported for herself. This 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3248, vaccine location=Right arm), via an unspecified route of administration on 19Jan2021 10:15 at single dose for COVID-19 immunisation.  Medical history included Hypothyroid. No known allergies. Patient was not pregnant. Concomitant medications included levothyroxine sodium (SYNTHROID) and multivitamin 4 x week. The patient previously received first dose of BNT162B2 (lot number=EL0140, vaccine location=Right arm) on 29Dec2020 at 12:15 PM at single dose for COVID-19 immunisation. On 19Jan2021 06:00 PM (8 hours after injection until 36 hours), patient experienced terrible headache, body ache, fatigue, tiredness, slept on and off all day, sore arm at injection site with warmth, swelling and tenderness. 36-72 hours: back to baseline except lingering headache. No treatment received for events. Patient did not have COVID prior vaccination, and did not test COVID post vaccination. The outcome of events was recovered.
I had my injection Friday 8/13 at 10:45. The next morning I woke up at 7:00 am my arm was very sore. I had blisters in the roof of my mouth. Extreme allergy symptoms itchy watery eyes sneezing and itchy skin and face .The next morning Sunday I woke up at 8:30 am my arm was still very sore but had a large red spot where I received the injection. The sores in my mouth we still present but a little worse.  Same allergy symptoms.Monday my injection spot was gone but very itchy. Same allergy symptoms. The blisters in my mouth were now popped and just sores . My tongue is slightly swollen but very sore . No open sores or blisters on my tongue. Started salt water rinse in mouth. My allergy symptoms went away Monday afternoon.Tuesday mouth sores still present and tongue sore and now sore throat. Still using salt water rinse. No allergy symptoms and my arm no longer sore or itchy.
A report was received from a health care professional on 11/24/03 concerning a 16 month old vaccinee (gender unspecified) who inadvertently received Fluvirin on 11/24/03. On 11/24/03, the vaccinee inadvertently received 0.25ml Fluvirin. The dose was to be a booster dose to the initial dose that was previously administered. No adverse symptoms were exhibited at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 1/9/04: A follow up report was received from a health care professional indicating that a 16 month old male vaccinee inadvertently received Fluvirin on 11/24/03. No adverse symptoms were reported at the time of reporting. No follow up pending.
Started with fever 101 and chills and nausea about 15 hours after second dose of Moderna vaccine. The symptoms continued for about 20 hours. Extreme fatigue the next day after shot. Two weeks later I am still tired and get a nauseous feeling when my stomach is empty.
Recieved influenza vaccine per IM injection at 10:00AM, 11-2-07. He remained in the building for a meeting.  At approximately 10:30-11:00AM he noted mental confusion but was able to walk to his car.  Upon entering his car, he was diaphoretic and pale but was able to drive out of the parking lot.  Was discovered ~11:20AM (several blocks from vaccine administration site) in his car sitting upright and awake but unable to respond.  Tranported to the ER via ambulance with a blood glucose of 22 upon admission.  Dextrose (Bristoject) administered IV push    X's 2.  Blood glucose after 30 minutes was ~180's.  Blood glucose dropped to ~30 at ~ 12:15PM and he was admitted for observation.  Blood glucose was monitored and remained in 70-160's range through the next day (11-3-07).  He was NPO and maintained on a continuous infusion of D5W.  Blood glucose dropped to 70 at ~noon on 11-3-07 but rose to 90 at ~1:00-2:00PM.  He was discharged from hospital to home mid-afternoon 11-3-07. 11/30/07-records received for DOS 11/02-11/3/07-DC DX: Hypoglycermia. While driving erratcially car stopped and found in car passed out.  No HX of diabetes. Did not eat night before. Day of admission, exercised and received flu shot. One hour later episode occurred.
Patient hospitalized for vaginal delivery within 6 weeks of receiving COVID vaccination. Baby was 8 pounds 15.6 ounces. Had a normal postpartum course and healthy baby.
This is a spontaneous report from a contactable physician.   A 63-year-old male patient of an unspecified race/ethnicity received pneumococcal 13-val conj vac (dipht crm197 protein), via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced pain of right shoulder region, decrease ROM (joint range of motion decreased) potential exists for incorrect site of administration. The outcome of the events was unknown. Pfizer is Marketing Authorization Holder Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) has been submitted the same report to the regulatory authorities.
Shortness of breath; Lymph nodes on the right side were swollen; fever about 24 hours afterwards; elevated heart rate in 130s for several hours; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (elevated heart rate in 130s for several hours), DYSPNOEA (Shortness of breath), LYMPHADENOPATHY (Lymph nodes on the right side were swollen) and PYREXIA (fever about 24 hours afterwards) in a 40-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced HEART RATE INCREASED (elevated heart rate in 130s for several hours) and PYREXIA (fever about 24 hours afterwards). On 23-Feb-2021, the patient experienced LYMPHADENOPATHY (Lymph nodes on the right side were swollen). On an unknown date, the patient experienced DYSPNOEA (Shortness of breath). On 05-Feb-2021, PYREXIA (fever about 24 hours afterwards) had resolved. At the time of the report, HEART RATE INCREASED (elevated heart rate in 130s for several hours), DYSPNOEA (Shortness of breath) and LYMPHADENOPATHY (Lymph nodes on the right side were swollen) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: between 92-94 Between 92-94.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was reported  Treatment information includes the patient was prescribed doxycycline but he has not started taking it.
SUSPECTED CLINICAL VACCINATION FAILURE; HAD A ROUGH CASE OF COVID; This spontaneous report received from a patient via social media via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number and expiry: Unknown) dose was not reported, 1 total, administered on MAR-2021 for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. The reporter stated that "I took the J & J in March and still had a rough case of Covid in July." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the had a rough case of covid and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000205017.; Sender's Comments: V0: 20211203782- COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
25 minutes following vaccine patient developed sensation of throat closing, chest tightness and shortness of breath. one dose of epinephrine was given with no improvement in symptoms. second dose was administered. pt remained awake and alert with stable vital signs throughout
1st dose , general aches. moderna 036B21A.left arm.  2nd Dose, moderna 045B21A,  dizzyness, right arm, hurts ,general aches, burning, uncomfortable &  severe fluid buildup on penis, below glans /  top side mostly on right side, hard & lumpy beneath skin now 05/07/2021  took 1 tylenol, 1 25 mg benedryl 05/06/2021.
This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. The patient concurrent condition and medical history were unknown. On 23-NOV-2015 the patient was vaccinated with an improperly stored dose of MMR II (Lot # K024036, expiration date 26-NOV-2015) (dose, administration route and anatomical site of administration were unknown). No concomitant therapies or adverse events were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Individual received vaccine at a retail pharmacy.  I am the facility vaccine coordinator at the individual's place of employment and received the adverse event report as follows:  "after 2nd dose of Moderna, I had extreme pain in arm and shoulder to the point I could not move it independently for 2 days, was painful to do anything with for 2 weeks after, was sick for 2 days with a fever of 100."
Gave patient a pediatric Pfizer vaccine #2 that was potentially not as effective due to temperature excursion.
After 1 week, developed a large red rash around the injection site.  Swelling, pain and redness.  Used ice to settle down the site and pain.  Persisted for 1 week and still there.
Sore, achy headache ,  Unable to sleep at all and during the whent shivers to sweating thru my clothes. My temperatue. in the night was 101.6. Coordianation and balance are affeced the following morning as is my spatial awareness of whereI am in a room relative to a counter or chair.  Sligj cognitive impact with spelling and typeing and forming thoughts which is taking a lot longer and my typin is slower by a third or more.
Client given adult dosage 1cc IM of Hep A vaccine instead of Ped dosage 0.5cc, no adverse reaction noted at time of injections, no reactions reported at this time.
Covid arm - skin rash at injection site, spread to area about 2in wide on arm, mild itchiness, still present at time of reporting; swollen lymph nodes on left side of neck
Patient contracted COVID soon after receiving the booster vaccination. Vaccine #1 on  1/14/2021 and Vaccine #2 on 2/3/2021. Loss of taste, fever, congestion, fatigue, body aches, cough, and headache
itchiness at injection site which then became swollen/looks like a huge mosquito bite, large horizontal oval shape; Itchiness at injection site; This is a spontaneous report from a contactable healthcare professional (patient). A 51-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 50-year-old, intramuscular in the right arm on 08Jan2021 at 14:00 at a single dose in the hospital for covid-19 immunization. Medical history included sulfa allergies. The patient is not pregnant at the time of vaccination. Concomitant medication included escitalopram oxalate (LEXAPRO) and celecoxib (CELEBREX). 8 days after vaccine (16Jan2021 at 13:00), patient developed itchiness at injection site which then became swollen by 9th day after vaccine (17Jan2021). Itchy and looks like a huge mosquito bite, large horizontal oval shape. The patient did not receive treatment for the events. Outcome of the events was recovering.  Information on the lot/batch number has been requested.
Soreness at injection site within 30 minutes. Achy, fatigue, chills at 2 hrs. Elevated temp at 4 hrs. Night chills fever at 100.8 at 12 hrs.