chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Inappropriate schedule of vaccine administered; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021 at 8:47 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 21-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Dec-2020, Polymerase chain reaction: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.   It was reported that the acute illnesses at the time of vaccination and up to one month before was unknown.    The treatment information was unknown.   This case was linked to MOD-2022-498946 (Patient Link).
Patient arrived to hospital by EMS, CPR in progress.  On arrival, patient had no spontaneous cardiac activity or respirations.
Non-stop nose bleed. Went to Emergency, admitted to hospital to stop bleeding. Got into my lungs, which caused a cancerous thing on my lung. Treated with radiation for five days.
Information has been received from a mother concerning her 12 year old daughter with hypersensitivity to red dye who in February 2007, was vaccinated with a first dose of Gardasil. In April 2007, the patient was vaccinated with her second dose of Gardasil there were no concomitant medications. On approximately 06-APR-2007 the patient experienced stomach pain, difficulty standing, and shallow breathing. The patient went to the emergency room where laboratory data revealed bilirubin was elevated. At the time of the report, the patient was recovering from the stomach pain, difficulty standing, shallow breathing, and elevated bilirubin. The consumer considered stomach pain, difficulty standing, shallow breathing, and elevated bilirubin to be disabling. Additional information has been requested.
never have any energy; I have had a cough since my 2nd dose on 12May2021 and I always feel tired and rundown. I never have any energy, and I cough every morning and have coughing fits during the day.; feel tired and rundown; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old male patient received bnt162b2 (BNT162B2, Solution for injection), administered in arm right, administration date 12May2021 13:30 (Lot number: EW0170) at the age of 47 years as dose 2, single and administered in arm left, administration date 27Dec2021 12:00 (Lot number: FL3197) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "ADHD" (unspecified if ongoing); "Depression" (unspecified if ongoing); "GERD" (unspecified if ongoing). Concomitant medication(s) included: PROZAC; ADDERALL; NEXIUM [ESOMEPRAZOLE SODIUM]; PANTOPRAZOLE SODIUM (ongoing). Past drug history included: Phenergen, reaction(s): "known allergies: Phenergen". Vaccination history included: Bnt162b2 (Prev dose product=COVID 19,, Prev dose brand=PFIZER,, Prev dose brand unknown=False,, Prev dose lot number=ER8731,, Prev dose lot unknown=False,, Prev dose administration date=21Apr2021,, Prev dose administration time=01:30 PM, Prev dose dose number=1,, Prev dose vaccine location=Left arm), administration date: 21Apr2021, when the patient was 47 years old, for Covid-19 immunization and vitamins. The following information was reported: ASTHENIA (non-serious) with onset 14May2021 10:00, outcome "not recovered", described as "never have any energy"; COUGH (non-serious) with onset 14May2021 10:00, outcome "not recovered", described as "I have had a cough since my 2nd dose on 12May2021 and I always feel tired and rundown. I never have any energy, and I cough every morning and have coughing fits during the day."; FATIGUE (non-serious) with onset 14May2021 10:00, outcome "not recovered", described as "feel tired and rundown". The events "never have any energy", "i have had a cough since my 2nd dose on 12may2021 and i always feel tired and rundown. i never have any energy, and i cough every morning and have coughing fits during the day." and "feel tired and rundown" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of asthenia, cough, fatigue.   Additional information: The patient was treated with decongestants, cough med, acid reducers. The patient did not receive any other vaccine in four weeks. The patient did not diagnosed with covid-19 prior vaccination. The patient was tested for Covid-19 post vaccination. Relevant laboratory tests and procedures are available in the appropriate section.  Follow-up attempts are completed. No further information is expected.
COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "obesity" (unspecified if ongoing); "pcos" (unspecified if ongoing). Concomitant medication(s) included: GUANFACINE; WELLBUTRIN; PRISTIQ. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Antiviral details Paxlovid. Product: COVID 19 Treatment, Treatment start date: 14Sep2022, Indication: Treatment of COVID-19. Adverse event: diarrhea, bad taste in mouth, abdominal cramps. The patient has been received vaccine and the patient received Other medication in 2 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient stated his tongue felt funny; then developed marked facial swelling and hives covering his entire body. Benadryl 1.5 tsp, then Epinephrine .15cc SQ given. Monitored. Patient recovered with no complications.
Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient was the sister in law of the reporter. The age at vaccination was not reported. The reporter stated that, his/her sister in law got the Shingles vaccine and guess what, she got a bad case of shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of primary vaccination schedule, time to onset for event and laboratory confirmation for shingles were not provided.
Kidney stones, Kidney Infection, Gallbladder stones, UTI, and Blood infection
diarrhea; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 87-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th April 2019, the patient received the 1st dose of Shingrix. On 8th April 2019, 1 days after receiving Shingrix, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was recovered/resolved.   It was unknown if the reporter considered the diarrhea to be related to Shingrix.  Additional details were provided as follows: The patient reported this case for herself. The patient received Shingrix in her left arm. The patient experienced diarrhea seven times at the night.  That was the only time she experienced symptoms and she did not seek medical attention for this. The patient consented to follow up.
foggy mind; Fever; chills / shivering; headache; body aches; weakness; Third dose was administered; Third dose was administered; This is a spontaneous report from a non-contactable nurse (patient). A 25-year-old female patient received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 30Sep2021 14:30 (Batch/Lot Number: FF8839) (at the age of 25 years old) as single dose for covid-19 immunisation. Medical history included asthma, and with known allergy to Penicillin. The patient was not pregnant at the time vaccination. The first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on 29Dec2020 via unspecified route of administration, administered in left arm (lot number: EL1284) (at the age of 24 years old) as single dose; and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on 21Jan2021 via unspecified route of administration, administered in left arm (lot number: EL1283) (at the age of 24 years old) as single dose; for covid-19 immunisation and experienced no adverse event. The patient's concomitant medications were not reported. After the third dose, on 01Oct2021 at 07:30am, the patient experienced foggy mind, fever, chills, shivering, headache, body aches, and weakness. The patient did not receive any treatment for the events. Patient did not have Covid prior to vaccination. Patient was not tested for Covid post vaccination. Outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Headache. Fever of 103 pulse 110. Dizziness BP 125/80. Rash on torso. Hives-neck and back "Lump" in throat. Ears ringing. Lethargy. Pallor.
Body felt like I was dying/ I almost have to go to the hospital, that is how bad it felt; Could not sleep at night; Felt more ache; Very very very tired, worst that when got COVID.; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Body felt like I was dying/ I almost have to go to the hospital, that is how bad it felt), INSOMNIA (Could not sleep at night), PAIN (Felt more ache) and FATIGUE (Very very very tired, worst that when got COVID.) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 13F21A, 031B21A and 007B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Previously administered products included for Product used for unknown indication: Flu shots (had flu shots every year and did not have any of this symptoms and some sore arm but not near this reaction.). Past adverse reactions to the above products included Pain in arm with Flu shots.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced FEELING ABNORMAL (Body felt like I was dying/ I almost have to go to the hospital, that is how bad it felt), INSOMNIA (Could not sleep at night), PAIN (Felt more ache) and FATIGUE (Very very very tired, worst that when got COVID.). At the time of the report, FEELING ABNORMAL (Body felt like I was dying/ I almost have to go to the hospital, that is how bad it felt), INSOMNIA (Could not sleep at night), PAIN (Felt more ache) and FATIGUE (Very very very tired, worst that when got COVID.) outcome was unknown.            No concomitant and treatment medication reported by the reporter.  After 8 to 10 hours of getting booster, patient experienced more side effects that when had COVID, stated like body felt like dying, could not sleep at night, almost have to go to the hospital. Patient felt more ache, very tired, worst that when got COVID. Patient mentioned knowing lots of nurses that have high risk exposure to COVID, that preferred not to take the booster.   This case was linked to MOD-2021-386173 (Patient Link).
Mother states fever up to 103.8 off & on from Tues to Sat 5-11 -> 5/15 states started within 36 hrs after vaccine; developed rash (faint pink) on Thurs 5/13; developed diarrhea & dehydration on Thurs.
The day after the first dose I experienced a subarachnoid hemorrhage.  I was hospitalized for 10 days due to the hemorrhage.
4/7/21 @ around 2:00 pm - dizziness, headache, "tunnel vision" and felt faint.  I drank water, stopped activity (walking) and rested.  It passed within about 30 mins.  These dizzy spells have reoccured 4 times since then.  4/8/21 @ 2:15 am - fever of 101.8, chills, muscle spasms, extreme muscle aches all over body esp in back and legs, **unable to use my hands freely.  My hands became very ridged and I could not open or close them well.  I could not hold a glass of water to take a Tylenol. I finally did take a Benedryl and a 500 mg Tylenol.  These symptoms lasted until around 5:00 am when I dozed back off.   I woke at 7:00 am feeling tired and had a bad headache.   My back and legs were still aching but were much better.  4/8/21 all-day - fatigue, bouts of dizziness, and nausea.   4/8/21 @9:00pm - diarrhea for about 4 hours.  Stomach pain.  4/9/21 @ around 3:00 dizziness that last about 30 mins  4/10/21 throughout the day - diarrhea and stomach pain  4/11/21 - tired and headache persists.  I started to feel more normal.  4/12/21- headache still there.  Won't go away.  I feel "foggy" and unable to think about things as I normally do.  I returned to work today and still feel "yucky". I feel as though I'm recovering from the flu.
Pain in the arm/Not a severe reaction; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (Pain in the arm/Not a severe reaction) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Pain in the arm/Not a severe reaction). At the time of the report, VACCINATION SITE PAIN (Pain in the arm/Not a severe reaction) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medication were not reported.   This case was linked to MOD-2021-406038, MOD-2021-406049 (Patient Link).
Information has been received from a nurse practitioner concerning a 73 year old female with osteoporosis and hypertension and no known drug allergies who on 17-FEB-2009 was vaccinated with ZOSTAVAX (Oka/Merck) 0.65 ml, subcutaneously (lot # 663175/1553X). Concomitant therapy included alendronate sodium (MSD), EVISTA, triamterene (manufacturer unknown), calcium (unspecified), vitamins (unspecified) and aspirin (manufacturer unknown). On 19-FEB-2009 the patient experienced erythema at the injection site 14 cm by 7 cm with central induration. Patient was also experiencing pruritis. At the time of the report, on 20-FEB-2009, the patient has not recovered from the symptoms. The patient sought medical attention by office visit and no lab diagnostics studies were performed. No further information is available.
Parent requested Varicella and Hepatitis A vaccines.  Patient was inadvertently given HPV9 instead of Hepatitis A vaccine.  The patient also received Varicella vaccine.  This was a vaccine administration error.  There was no adverse event reported.
6 months later: I am been so sick since April or May2022. Hospital. I could not breathe, I was whizzing. My lungs were like I had air in my lungs and 2 days late I had blood clots in my right leg. I went to the doctor and was sent to the ER for my breathing and was sent to the hospital. I was diagnosed DVT (Deep vein thrombosis). When I was in the hospital for 10 days and I had blood clots in both lungs and one in my right leg. May 11 to 15 I went to  get a doppler for my veins. Now I have H pylori.
Low grade fever, chills, headache, fatigue.  Duration one day.  Redness, soreness, and internal itching at the injection site.  Still occurring although lessening.
I started with typical side effects- headache, fever, flu like feeling.   I started getting full body joint pain- severe joint pain in less than 12 hours after 2nd dose. Full body joint pain and fever continued throughout the night of the 29th (shot on 28th). Today, the 30th while better my hips and knees are still experiencing the sever joint pain but it is no longer all over my body.
Vomiting; Headache; Dizziness; When walking she grabs onto the wall; has no appetite and is really tired; head feels like she is going in circles; has no appetite and is really tired; This is a spontaneous report from a contactable consumer (patient's friend). A 68-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 2 via an unspecified route of administration on 02May2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included patient is a diabetic and takes unspecified medications for it. Two weeks after getting the vaccine (May2021), the patient experienced dizziness, vomiting, and headache. The patient has no appetite and is really tired. It was reported that it might be the patient's sugar as she is diabetic and takes medications for it. The patient needs her machine to check her sugar and hasn't done that yet and she needs to know what to do.  It was also reported that when walking she grabs onto the wall, like she is going to fall. Her head feels like she is going in circles and it's been 2 weeks of that. The events required physician office visit. The outcome of the events was not recovered.  Information about lot/batch has been requested.
Nasal/sinus congestion appeared Mon 4/5 (17-days after injection)  Congestion resolved on Wed 4/7, but right ear had very high pitched humming (tinnitus).  On Sat 4/10 both ears began humming (tinnitus).    Mild fullness sensation in both ears, slight drainage from Eustachian tubes (back of throat), no active infection.   Hearing test results showed loss of 10-40 decibel range in right ear at all frequencies: left ear mostly normal   Prescribed prednisone, 40 mg/day for 3 days (symtoms remained)  Prescribed methypredisone 6-day tapering dose pack (symptoms remained)  Delayed second dose of Moderna vaccine until Mon 4/26 (5.5 weeks after first dose)
p/vax pt fell for no reason;rt leg became stiff & wouldn't hold pt up even w/cane or walker;then couldn't move other leg; told all muscle tone was gone from both 12/12/00 states the pt remains wheel chair bound due to the paralysis of legs. A Foley catheter in place due to excessive accumulation of fluid and congestive heart failure.
Pt received flu vaccine on 10/20/06. Reports having Flu like symptoms on 10/23/06. Pt states having chills, fever (but did not take temp). Headache and heart racing. Pt reports having a little congestion the day she got her shot but did not say anything. Pt states she has not gone to the doctor but will call him today because she cannot get rid of the cough. Pt states she will never get another flu shot.
Awoke in the night following the 2nd dose of the vaccine, with an irregular heart rhythm and elevated heart rate.  I contacted the Hospital and was told to come in for an ER eval. --I did go to the ER and was treated for Rapid Atrial Fibrillation.  My heart rate was approx. 130 and B/P was approx. 158/100 --both are very elevated for me. (my resting heart rate avg is 50-55 and B/P is avg 124/80) Was given Cardizem IV push and then tablet of Cardizem while in the ER.  Then later on same day saw my Cardiologist, who confirmed I was still in Afib.
Moderna not indicated for Pt's age. RN administered vaccine.  Pt denies any symptoms and will be given 2nd dose per CDC and Manufacturer guidelines for her age.
Very sore arm - red - unable to use arm to dress, comb hair or brush hair - teeth etc. This has lasted for all time since October 6th, 2010. Arm was perfect before flu vaccination.
Severe headache, lethargia, nauseau, chills.  Vomited at 4 PM and again at 5 PM.  Ached all over like the flu.  Unable to eat dinner.  Still achy and nauseous the next morning and ate lightly.  Given 2 1/2 teasons Ibupropen at 9 PM 12/14 and slept all night.  Given same doseage at 8:30 AM today and again an 12:30 PM.  Felt better by 10: AM.
Patient tested positive for COVID-19; Sore throat; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient tested positive for COVID-19) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), CHILLS (Chills) and PYREXIA (Fever). On 21-Feb-2021, the patient experienced COVID-19 (Patient tested positive for COVID-19). At the time of the report, COVID-19 (Patient tested positive for COVID-19), OROPHARYNGEAL PAIN (Sore throat), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details were provided.  The patient was scheduled to receive his second dose on 13 March 2021.  The patient received an antibody infusion on 23 February 2021.  Company Comment : 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. Additionaly, based on the mechanism of action of mRNA-1273 the event COVID 19 is unlikely related to the vaccine.; Sender'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. Additionaly, based on the mechanism of action of mRNA-1273 the event COVID 19 is unlikely related to the vaccine.
Breakthrough case admission after 4 vaccines Moderna 3/1/21 Lot# 010A21A;  Moderna 3/29/21 Lot# 018B21A;  Moderna 10/19/21 Lot# 076C21A;  Moderna 7/25/22 Lot# 016B22S