chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient who was outside of the labeled age of indication for ActHib, will be receiving ActHib with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from pharmacist and non-health care professional (Reference number: 00720491) and transmitted to Sanofi on 11-Aug-2021.  This case involves a patient of unknown age who was outside of the labeled age of indication for HIB (PRP/T) VACCINE [ACT-HIB], will be receiving mentioned vaccine (circumstance or information capable of leading to medication error).  Past medical history, medical treatment(s), vaccination(s), and family history were not provided.  The patient did not receive any concomitant medications and vaccines.  On an unknown date, the patient received an unknown dose of suspect HIB (PRP/T) VACCINE (lot number: unknown and expiration date: unknown) via unknown route in unknown administration site for prophylactic vaccination.  It was case of potential medication error due to circumstance or information capable of leading to medication error (latency: same day).  It was reported, "Pharmacist is asking if ActHIB is only for 2 months through 5 years of age? The pharmacist has a patient who is outside of the labeled age of indication for ActHib. The patient will be receiving ActHib because he/she will be having a splenectomy secondary to trauma".  No adverse events were reported at the time of this report.  At the time of this report, outcome of the event was reported as unknown.  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 the Directive. 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.  There will be no information available regarding batch number in this case.
This case was reported by a lawyer and described the occurrence of injection site pain in an adult female subject who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other healthcare professional has not verified this report. On 11 October 2011 the subject received a dose of FLUARIX in the left arm. Within months of vaccination with FLUARIX (described as "shortly after the injection" and the report was received by GlaxoSmithKline on 17 November 2011), the subject experienced injection site pain (severe pain in the left arm at the site of the injection). At the time of reporting, the subject was wearing a sling on her left arm. She was unable to move the arm and activities of daily living were impaired (she had missed several weeks of work because of her condition). It was reported that the subject had recently consulted with a neurologist and the neurologist thought that the subject's condition was caused by defective vaccine. It was reported that the subject may have serious and permanent nerve damage in her left arm which may result in her inability to work and continue in her employment as a realtor. At the time of reporting the outcome of the events was unresolved.
Papules and early vesicles suggestion of post vaccine chicken pox. Distributed on scalp, trunk and extremities.
On 7/23/08 12yr old girl was given yellow fever vaccine without me realizing 13days earily she received MMR from her Private Care Privider on 7/10/08. After giving her the yellow fever vaccine and reviewing NCIR I realized the girl had been given a invalid dose of yellow fever. The girl and family were leaving 8/22/08 for Nigeria staying 9 days. When invalid dose of yellow fever was given CDC was called who informed use studies had been done on single-antigen measles vaccine that demonstrated that yellow fever vaccine is not affected by measles vaccine given 1-27 days earlier.  The effect of nonsimultaneously administered rebella, mumps, varicell, aoster, LAIV and yellow fever vaccines in not known.  Client parents were informed of incidence and told to return for a valid yellow fever vaccine.
4/25, 4pm, 2nd dose of Pfizer.  Mass vax scheduling second dose 17days from  1st shot. 7pm, fatigue, mild sore arm. 4/26/21 - 7am SEVERE BONE PAIN started in vertebrae, hip, coccyx, knees, ankles, completely unmitigated by 1000mg Tylenol and 800mg ibuprofen, FEVER - w/ meds still 99.7, CHILLS - moderate, DIARRHEA/NAUSEA - mild, fatigue - moderate, headache - mild, mitigated by meds. Would have gone to hospital if I thought they could do something. ABDOMINAL PAINS - intermittent, HEART FLUBBING - mild. 7pm, BONE PAIN reduced to moderate by 9pm, fever broke. 4/27/21 - felt like I had the flu - FATIGUE, CHILLS, NAUSEA, - all tolerable and mild-moderate, ABDOMINAL PAINS - intermittent, HEART FLUBBING - mild. 4/28/21  - FATIGUE - moderate (worse), ABDOMINAL PAINS - moderate, not gastro-related,  HEART FLUBBING - mild.  Third day missed of work. Heading to doctor.
The patient had a reaction to the flu shot it was fatigue, and fever for approximately 2 days.
Having no previous history of ANY indigestion, or GI problems,  I had a sudden onset of acute epigastric pain beginning March 15th, 2021,  followed by frequent, unrelenting vomiting, eventual fever, and White Blood Cell count of 20,000. Saw internist, she sent me to an emergency room and then had a subsequent admission to a hospital on March 16. Cholecystectomy was done on March 17, 2021 after 24 hours IV antibiotics to control sepsis prior to surgery.
Drowsy after vaccination. Next day fever from 101.8-102.9 degrees, fever resided when took medication. Fever up and down for 5 days in total, always taking Motrin and Tylenol on a regular basis. During these days child was moaning like in pain, weak because did not want to eat but was not throwing up.
Sweaty, light headed, blurred vision.  Felt like she was going to pass out. Stayed longer for observation.  BP after vaccine 77/49.  BP 15 minutes later 150/81. BP after 30 minutes 148-/94 HR 66
I received the 2nd Covid injection.  I went to the 15-minute waiting area.  The waiting area was full, so my husband and I were standing.  I stand and work every day, so this was not difficult.  I texted my daughter, who is a hospital employee, and told her that we had a super experience with no wait and had already received our 2nd dose.  However, 5 to 7 minutes after the injection, I SUDDENLY felt dizzy and weak and had to sit down.  Within a minute or so, I could not stand or open my eyes.  The weakness made it difficult to breath or talk.  My husband had to lift me up into a wheelchair.  I was taken to the ER.  For the longest time, I could not even open my eyes or talk above a whisper. After 4 hours, I was able to get my eyes open and talk better.  I, gradually, was able to move my hands and feet.  Last of all, I could move my hips and walk.   It was as if my body had been put to sleep.  I could feel everything but my body wouldn?t move.  As it wore off, my face and limbs felt slightly tingly.  I was, basically, fine after 5 hours other than being tired from the experience. The doctors had no explanation for what happened and said it must be an emotional response to getting the shot.  They wrote that I was not exerting enough effort to move my body.  One said that I was hyperventilating when I pulled my mask up to breathe after he told me to hold my leg in the air.  Though I tried, I was too weak to hold my leg up and it fell to the bed. The doctor told me that I should not tell anyone about what had happened or people would not come to get the Covid vaccination.  He obviously knew that SOMETHING had happened that I couldn't control but he didn't put that in his report!
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Jan2023) Positive, notes: Tested positive 5 days ago. Therapeutic measures were taken as a result of drug ineffective, covid-19 treated with Paxlovid started on 06Jan2023 and stopped on 10Jan2023.   The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Site of Comvax injection left arm. 1/2 dollar size red/warm welt, tender to touch.
Site: Itching at Injection Site-Mild, Systemic: approximately 0.5cm bulla located at injection site, no sign of infection-Mild
Immediately following vaccinations, pt's arm started swelling. Pt had fever of 101 later that day. Mother states pt broke out in a rash on upper left arm and also had a fine rash across her abdomen lasting for 3 days. Mother put cold cloth on site for 3 days and gave Motrin and Advil for fever. No medical attention was received.
Spontaneous bleed- nose and rectum; Dizziness; Spontaneous bleed- nose and rectum; Headache; Aches; This is a spontaneous report from a non-contactable consumer (patient herself). A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6198) via an unspecified route of administration, administered in left arm on 25Feb2021 at 08:15 A.M. (at the age of 75 years old) as 1st dose single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient receive other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and the patient has not been tested for COVID-19 since the vaccination. On 26Feb2021, it was reported that the patient experienced spontaneous bleeding in nose and rectum. The patient also experienced dizziness, headache and aches. Therapeutic measures were taken as a result of spontaneous bleeding in nose and rectum, dizziness, headache, aches. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
ongoing arrhythmia with constant; chest continues to feel tight; 3 PVCs; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ARRHYTHMIA (ongoing arrhythmia with constant) and VENTRICULAR EXTRASYSTOLES (3 PVCs) in a patient of an unknown age and gender 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 was provided by the reporter.     On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced VENTRICULAR EXTRASYSTOLES (3 PVCs) (seriousness criterion medically significant). On an unknown date, the patient experienced ARRHYTHMIA (ongoing arrhythmia with constant) (seriousness criterion medically significant) and CHEST DISCOMFORT (chest continues to feel tight). On 17-Feb-2021, VENTRICULAR EXTRASYSTOLES (3 PVCs) outcome was unknown. At the time of the report, ARRHYTHMIA (ongoing arrhythmia with constant) and CHEST DISCOMFORT (chest continues to feel tight) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided by the reporter.  No treatment details were provided by the reporter.  it was reported that Patient was referred to cardiologist who is in the middle of workup, having ordered a nuclear stress test and Echocardiogram, This week patient began one week patch monitoring protocol.  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.   This case was linked to MOD-2021-239114 (Patient Link).; 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
Strong body aches starting 7 hours after shot lasting 24 hours, mild body aches for following 36 hours Night sweats for 3 nights following shot  Heartburn starting 24 hours after shot, ongoing
Moderna COVID-19 vaccine had a storage excursion and was kept in the fridge for 31 days instead of the recommended 30 days.  Analysis by Moderna indicated the lot of vaccine maintained the activity necessary to protect against SARS-Cov2 at the time of administration.  No adverse events reported beyond normal s/e from vaccine.
Left arm sore at injection site, woke up at 4 am arm, elbow and wrist all very sore like burning. Slowly faded away as I woke up and used my arm. Now mainly sore just at injection site.; elbow and wrist all very sore like burning. Slowly faded away as I woke up and used my arm; woke up at 4 am arm, elbow and wrist all very sore like burning. Slowly faded away as I woke up and used my arm; elbow and wrist all very sore like burning; But deep muscle soreness; joint tight ness after period of no movement (while sleeping); This is a spontaneous report from a contactable consumer (patient). A 32-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date not reported), via an unspecified route of administration, administered in left arm on 26Aug2021 12:00 (at the age of 32 years) as dose 1, single for COVID-19 immunization. The patient medical history included COVID-19 from an unknown date. Patient had no known allergies and no other medical history. The patient's concomitant medications included unspecified vitamins. The patient was not pregnant at the time of vaccination. Patient not COVID tested post vaccination. On 27Aug2021 04:00, the patient experienced left arm sore at injection site, woke up at 4 am arm, elbow and wrist all very sore like burning. Slowly faded away as she woke up and used her arm. Now mainly sore just at injection site. But deep muscle soreness and joint tightness after period of no movement (while sleeping) on 27Aug2021 04:00. Patient did not receive any treatment for events. The outcome if all the events was recovering.  Follow-up attempts completed. The lot/batch number is not available despite the follow-up attempts made. No further information is expected.
Large, soft, raised and swollen Fontanelle, 103.2 fever, exagerated Moro reflex two intervals, 5 or 8 startles 20 seconds apart over a four hour period.
Had severe pain in my right arm where pneumonia vaccine was administered. Taken 1st vaccine 10 yrs ago, nothing happen I was fine. Excruciating pain, moaning, groaning all in night. Finally relief came next day of mid morning.
Covid symptoms rebounded, test came positive after 5 days of negative; Covid symptoms rebounded, test came positive after 5 days of negative; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) 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 was not reported. There were no concomitant medications. No Other medication in 2weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Covid symptoms rebounded, test came positive after 5 days of negative". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: test came positive after 5 days of negative; Negative, notes: test came positive after 5 days of negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 21-FEB-2017, the patient was inadvertently vaccinated with a dose of PROQUAD and a dose of included VARIVAX both vaccines subcutaneously, (dose, anatomical location, lot number and expiration date were not reported) for prophylaxis. No adverse effects reported. Additional information is not expected because there was no consent for follow-up.
I developed severe abdominal pain and was diagnosed with colitis. I was seen in ER. I have no idea if the vaccine called this.
day 1 headache, tired day 2 headache, tired, temp ranging from 99 to 100.9 Benadryl, Tylenol
Hepatitis B vaccine was administered on 13-DEC-2021, 08-FEB-2022 and 06-SEP-2022; Hepatitis B vaccine was administered on 13-DEC-2021, 08-FEB-2022 and 06-SEP-2022; This spontaneous report was received from a nurse and refers to an 8-weeks-old female patient. The patient's pertinent medical history, drug reactions and allergies were not reported. Concomitant vaccines included diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL), pneumococcal vaccine conj 13v (crm197) (PREVENAR 13), and rotavirus vaccine, live, oral, pentavalent (ROTATEQ).  On 13-DEC-2021, the patient was vaccinated with the first dose of Hepatitis B Vaccine (manufacturer unknown) administered as prophylaxis (Strength, dose, route of administration, vaccination scheme, anatomical location, lot umber and expiration date were not reported). On 08-FEB-2022, she was vaccinated with the second dose of Hepatitis B Vaccine (manufacturer unknown) (Strength, dose, route of administration, vaccination scheme, anatomical location, lot umber and expiration date were not reported) (Inappropriate schedule of product administration), and on 06-SEP-2022, the patient was vaccinated with the third dose of Hepatitis B Vaccine (manufacturer unknown) (Strength, dose, route of administration, vaccination scheme, anatomical location, lot umber and expiration date were not reported) (Inappropriate schedule of product administration).  This is one of several reports from the same reporter. This is one of two reports for the same patient.
tiredness; mild soft stool; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number:Unknown), via an unspecified route of administration on 17Feb2021 at a single dose for covid-19 immunisation. Medical history included ITP (and would like to measure his immune response. Asking if we have additional test to asses this). The patient's concomitant medications were not reported. The patient experienced tiredness and mild soft stool. His second dose was scheduled on 10Mar2021.The outcome of the events was unknown.
Father noted a raised area the size of a quarter on 6/4/08 on the childs Right Arm. On 6/5/08 the swelling increased and the lump was hard and warm. Also on 6/5/08 father noted a quarter size lump on the Left Arm.
Nausea; Covid arm; I felt real sick the second day; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), VACCINATION SITE REACTION (Covid arm) and ILLNESS (I felt real sick the second day) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included General medications for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nausea), VACCINATION SITE REACTION (Covid arm) and ILLNESS (I felt real sick the second day). At the time of the report, NAUSEA (Nausea), VACCINATION SITE REACTION (Covid arm) and ILLNESS (I felt real sick the second day) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-109781 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-109781:HUSBAND CASE
Came down with the flu.  Vomited for three mornings, slept for three days, only getting out of bed to vomit and try to drink fluids.  Dizzy, achy, shaky. Could first eat solid food Feb.18, 2010 PM.
Patient had a circular rash around the injection site about 2 & 1/2 inches in diameter that started one week after injection into the left deltoid. Patient was told to apply hydrocortisone cream several times a day, and to take Benadryl capsules. The rash caused itching. The rash has cleared 3 days later. Covid-arm?
extreme sharp pain in shoulder to elbow. Patient felt this whenever patient activates arm, do push up or lift; This is a spontaneous report received from a contactable consumer (patient). A 49-year-old female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. It was reported that after getting first dose of the Pfizer COVID 19 vaccine patient experienced extreme sharp pain in shoulder to elbow. Patient felt this whenever patient activates arm, do push up or lift. Added that patient was experiencing this for 15 days already. Second dose of vaccine was scheduled next week Wednesday (as of 08Apr2021). Outcome of the event was not resolved.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Painful lymph node in left armpit.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534), via an unspecified route of administration in the left arm on 27Mar2021 at 13:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as not available (n/a). The patient did not had allergy to any medications, food, or other products. Concomitant medications included quetiapine (MANUFACTURER UNKNOWN), MAXI-HAIR PLUS, D3 (MANUFACTURER UNKNOWN), ibuprofen (MANUFACTURER UNKNOWN), and LINZESS all taken for an unknown indication, from unknown dates. The patient previously received a first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203), via an unspecified route of administration in the left arm on 06Mar2021 at 13:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 28Mar2021 at 11:00, the patient experienced painful lymph node in the left armpit. The patient did not receive any treatment for the adverse event. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event painful lymph node in the left armpit was not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.