chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Regurgitation of medication; A nurse reported that an infant regurgitated ROTATEQ on unspecific date.; This spontaneous information was received from a nurse concerning an infant patient of unknown age and gender. Patient's pertinent medical history, current condition and concomitant medications were not provided.  On an unknown date, the patient received a rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally for prophylaxis (strength, dose, frequency, lot number and expiration date was not provided).  On an unspecified date, the patient regurgitated the whole rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (accidental underdose/ regurgitation). The outcome of the event was not provided.  The causal relationship between rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and the events was not provided.
At the night of my third vaccination, I began to experience body chills and nausea, leading to dry heaving. Headache came along with these symptoms. These symptoms progressed for 48 hours post vaccination and then subsided. I stayed home and took Tylenol for symptoms. These were also the same symptoms that I had post second vaccination.
similar reaction/symptoms; This spontaneous report has been received from the patient's sister via GlaxoSmithKline (GSK), regarding a 74-year-old male patient. Information regarding the patient's historical conditions, past drugs reactions or allergies, concurrent conditions or concomitant therapies was not provided.   Approximately in November 2020 (reported as "about a year ago"), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) as prophylaxis (formulation, dose, dose number, vaccination scheme frequency, route and anatomical location of administration, lot number and expiration date were not reported), and influenza vaccine (FLUZONE).   Consequently, when he received the vaccines similar had a reaction and symptoms (unspecified) (adverse event following immunisation). However, it was not reported if test or studies were performed regarding the event. The outcome of the events was not provided.   The causality assessment between the event and the suspect therapy was not provided.   This is an amended report. The events of Guillain-Barre syndrome, gait disturbance, Ill-defined disorder, pyrexia, nausea, chills and asthenia were deleted, and adverse event following immunization was added. The narrative was updated accordingly.  This case has been downgraded as the serious event was deleted from the case.
Mild diarrhea for 1-2 days starting day following oral administration of rotateq.  5-6 watery stools per day, no dehydration or other clinical symptoms.  Diarrhea resolved in appx 36 hours.
THE PATIEND ANSERED THE COIVD VACCION CONSET FORM. WHEN ASKED ABOUT PREVIOUS COVID VACCINES HE ANSWERED "NO". WHEN THE VACCINE WAS ENTERED INTO THE SYSTEM, IT WAS NOTED THAT HE RECEIVED 2 DOSESOF MODERNA ON MARCH 4 & APRIL 1. THE PATIENT STATED SINCE HE WORKED IN EDUCATIONHE THOUGHT HE NEEDED ANOTHER SHOT
Local Symptoms: Pain- discomfort, redness, swelling, itching. General symptoms: Chills, fever, headaches, joint pains, muscle pains, fatigue, nausea, eye pain, back pain Narrative:
got a reaction after the vaccines, bad red mark, big one on arm, slight reaction; got a reaction after the vaccines, bad red mark, big one on arm, slight reaction; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE REACTION (got a reaction after the vaccines, bad red mark, big one on arm, slight reaction) and VACCINATION SITE ERYTHEMA (got a reaction after the vaccines, bad red mark, big one on arm, slight reaction) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 011M2017) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: SIMVASTATIN. Past adverse reactions to the above products included No adverse event with SIMVASTATIN.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (got a reaction after the vaccines, bad red mark, big one on arm, slight reaction) and VACCINATION SITE ERYTHEMA (got a reaction after the vaccines, bad red mark, big one on arm, slight reaction). At the time of the report, VACCINATION SITE REACTION (got a reaction after the vaccines, bad red mark, big one on arm, slight reaction) and VACCINATION SITE ERYTHEMA (got a reaction after the vaccines, bad red mark, big one on arm, slight reaction) outcome was unknown.            No concomitant medication was reported. Patient did not take any medication for any adverse reactions.   This case was linked to MOD-2022-607759 (Patient Link).
Currently in hospital as of 06/ 05/ 21 kidney blockage/ surgery needed,  Uti, pneumonia, possibly more. Daughter also was in hospital with lung problems...got shots at same time.
5/10/01; increased fever of 105F, not reduced by Tylenol until the next day. (Cough, eye infection the following week). Went to ER at 20:00. 5/11/01; rash on upper left thigh in the afternoon and rash on right leg and left foot in the evening.
This spontaneous report was received from a pharmacist refers to a female patient of unknown age. Information regarding patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. On an unknown date, the patient was vaccinated with M-M-R II (dosing details were not provided) for prophylaxis. Pharmacist reported that after vaccination, a small amount of the vaccine was observed on the patient's skin (incorrect dose administered and exposure via skin contact). The patient had not experienced any adverse effects at the time. Additional information has been requested.
COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Penicillin. Past adverse reactions to the above products included Allergy with Penicillin. Concomitant products included BUPRENORPHINE, ROPINIROLE and OMEPRAZOLE for an unknown indication.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-May-2022, the patient experienced COVID-19 (COVID-19). The patient was treated with TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) on 15-May-2022 for COVID-19 treatment, at a dose of 1 dosage form. At the time of the report, COVID-19 (COVID-19) had not resolved.            Last date of administration of Pfizer covid-19 vaccine was 19-May-2021. Patient took other medications/products within 2 weeks of starting COVID-19 treatment.  Device Date was reported as 23-May-2022.  No treatment medication was provided.  Company Comment: This is a spontaneous case concerning a 46-year-old male patient with no relevant medical history, who experienced the unexpected non-serious adverse event of special interest, COVID-19 which occurred approximately 6 months after receiving the third dose of mRNA-1273 Vaccine. As reported, the patient was treated with Pfizer for COVID-19, the patient tested positive on Days 6 & 7 and on Day 9 the test was fully "strongly" positive again and had some cold symptoms. No further clinical or treatment details were given. It was reported that the outcome of the event has not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 46-year-old male patient with no relevant medical history, who experienced the unexpected non-serious adverse event of special interest, COVID-19 which occurred approximately 6 months after receiving the third dose of mRNA-1273 Vaccine. As reported, the patient was treated with Pfizer for COVID-19, the patient tested positive on Days 6 & 7 and on Day 9 the test was fully "strongly" positive again and had some cold symptoms. No further clinical or treatment details were given. It was reported that the outcome of the event has not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
24 hours later I came down with diarrhea; This is a spontaneous report from a non-contactable consumer reporting for herself. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on 20Jan2021 11:00 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated, "I had the vaccine yesterday morning at 11 o'clock, and 24 hours later I came down with diarrhea (21Jan2021). How long will it last? Okay... other than contacting the doctor, do you have Diet recommendations? I haven't eaten anything." The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
lip swelling, eye lid swelling began approximately 36 hours after vaccination. Patient presented to ED and was treated with benadryl, protonix and prednisone.  Plan to discharge home with the same
Information has been received from a physician concerning a 23-year-old female patient with no known drug allergies, a history of Spherocytosis, and splenectomy for Spherocytosis at age 19 years.  On 07/14/1980 and 01/10/1995, she was vaccinated with a dose, measles virus vaccine live(+) mumps virus vaccine live (+) rubella virus vaccine live (second generation).  There was no concomitant medication.  Subsequently it is reported the patient's current titer is negative for measles and mumps.  Additional information has been requested.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender, who were administered improperly stored doses of vaccinated with PROQUAD (Merck) since 10-DEC-2014. No adverse events were reported. This is one of two reports received from the same source. Additional information has been requested.
Back spasms requiring patient to lie down. Patient was unable to get up for a few minutes. 911 alerted and fire department came and her vitals were normal. Patient was then able to sit up.
Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) 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.     On 01-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced COVID-19 (Covid-19). The patient was treated with VITAMINS NOS at a dose of UNK dosage form and PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, COVID-19 (Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was not reported.  Other treatment medication included cough medication.
Very sick and feels to vomit; Very sick and feels to vomit; Shoulders and both arms are hurting; Headache; Dizzy; Shoulders and both arms are hurting; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), NAUSEA (non-serious), outcome "unknown" and all described as "Very sick and feels to vomit"; ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "Shoulders and both arms are hurting"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; DIZZINESS (non-serious), outcome "unknown", described as "Dizzy". Additional information: Reporter stated, His shoulders and both arms are hurting. He has headache, dizzy and feels like he got to vomit. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The request is due to the fact that at the time of the vaccination the phlebotomist said "there is an error" and proceeded to remove the syringe and did not find the needle and checked the arm and said ""it is not inside the arm." The needle at the end appeared and it was INSIDE the syringe. my concern is to know if they injected me 100% of the vaccine or 10% I think they do not know, then do I need to? Another first dose to be scheduled, or not.? I am waiting for your information Thank you for your help
1/16/22 BODY ACHES     Severity:MODERATE Onset quality:GRADUAL Duration: 2 DAYS Timing:INTERMITTENT Progression:WORSENING Context: EXPOSED AT WORK  Relieved by:NOTHING Worsened by: NOTHING Ineffective treatments: OTC MEDICATIONS Associated symptoms: HA, COUGH,   Review of Systems  Constitutional: Positive for chills, fatigue and fever.  HENT: Positive for congestion, rhinorrhea and sinus pain.   Respiratory: Positive for cough.   Gastrointestinal: Negative for diarrhea and nausea.  Neurological: Positive for headaches.
feels flushing; tingling on her legs / extremities; very sore neck on the same side (left) she had shot/pain on her neck on the same side she had her shot; flu like symptom; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (feels flushing), PARAESTHESIA (tingling on her legs / extremities), NECK PAIN (very sore neck on the same side (left) she had shot/pain on her neck on the same side she had her shot) and INFLUENZA LIKE ILLNESS (flu like symptom) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder. Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Dec-2021, the patient experienced FLUSHING (feels flushing), PARAESTHESIA (tingling on her legs / extremities) and INFLUENZA LIKE ILLNESS (flu like symptom). 09-Dec-2021, the patient experienced NECK PAIN (very sore neck on the same side (left) she had shot/pain on her neck on the same side she had her shot). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, FLUSHING (feels flushing), PARAESTHESIA (tingling on her legs / extremities), NECK PAIN (very sore neck on the same side (left) she had shot/pain on her neck on the same side she had her shot) and INFLUENZA LIKE ILLNESS (flu like symptom) outcome was unknown.            patient Took an Advil 15-20 mins prior shot. Patient was  on Thyroid and blood pressure medications and taking supplements.   This case was linked to MOD-2021-028351 (Patient Link).
This spontaneous report as received from a medical assistant, refers to an unknown number of patients of unknown demographics. Patients' pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On unknown dates, for the past two years, the patients were vaccinated with improperly stored doses of VARIVAX (strength, dosing details, anatomical location, lot# and expiration date were unknown) for prophylaxis. The vaccine was reconstituted with Sterile Merck Diluent. The Medical assistant refused to provide any additional information including excursion details. No PQC was filed. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1708USA013798: US-009507513-1709USA000104.
Got Covid 12/26/2022 tested positive. Started PAXLOVID 12/30/2023. Really bad sinus congestion.
Miscarriage at around 7 weeks (I found out at 9 weeks pregnant).  No symptoms were present. I found out about the miscarriage because of a routine ultrasound- the fetus did not have a heartbeat and was measuring at 7 weeks.
On 3/30/09, pt presented w/ about 14 hr hx of fever, headache and vomiting and 20 min of purpuric rash. Pt directed to ER then Peds ICU. CSF increased protein, increased WBC (+) gram stain. Gram (-) intracellular diplococci.  4/20/09 MR received for DOS 3/30-4/5/2009 with d/C DX:  Menigococcus.  Pt initially presented to PCP with c/o fever, vomiting and petechial/purpuric lesionson extremities. Referred to ED to eval and tx.  PE (+) for waxing/waning mental status changes with intermittant slurred incoherent speech, decreased ROM of the neck, nuchal rigidity, diffuse petechiae and hemorrhagic macules.  Admitted for concern of neisseria meningitidis. Tx abx with improvement in mental status and rashes. Noted to have bloody urine. D/C 4/5/09 for outpt f/u.
I ran a temp of 99.5 which came down to 99 with tylenol. The low grade fever and chills lasted 36 hours. My normal oral temp is 97. Had trouble sleeping. Two weeks later I developed a circular rash on my right arm where the vaccination was given. I am day 3 into the rash which is fading. No treatments were needed for the rash
Information was received from a medical assistant referring to multiple unknown patients. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unspecified dates, the patients were administered doses of improperly stored (Oka/Merck) VARIVAX (lot# M002061, expired date 12-JAN-2018; lot# M004330, expired date 26-JAN-2018; lot# M006724, expired date 28-FEB-2018; lot# reported as M009764, expired date 23-FEB-2018) (dose and route unknown). The vaccines were exposed under 8.8 Fahrenheit degree (F) for 30 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Developed itching at injection site 9 days after vaccination; progressed to a large hot red area  on upper right arm with very hard lump. Went to urgent care on 1/15 at 8pm. Area measured 2 inches X 3.5 inches. Prescription for Keflex. On 1/16/21 area remains red and hot and increased in size to 3 inches X 4.5 inches.
Child received immunz. Seemed fine, when she got up to leave felt faint seemed to almost pass out, pale, low B/P. Laid child on table gave Epi 1.7 ml given. Called ambulance sent to ER.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 30-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter. No temperature excursions. Dose administered after 30-day Use By Date or after manufacturer date of expiry. Patient were monitored for at least 15 minutes after the injection with no adverse events reported.
Low grade fever; chills; soreness & bruising at injection site; soreness & bruising at injection site; This is a spontaneous report from a contactable consumer(patient). A 51-years-old non-Pregnant female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EP6955), via an unspecified route of administration on 01Apr2021 at 09:30 into right arm as SINGLE DOSE for COVID-19 immunization at clinic. The patient had received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3247), via an unspecified route of administration on 09Mar2021 at 11:30 am into right arm as SINGLE DOSE for COVID-19 immunization at clinic. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 01Apr2021 at 22:00, the patient experienced Low grade fever, chills, soreness & bruising at injection site. No treatment was given for the events. The outcome of the events was recovered.  No follow-up attempts are needed. No further information is expected.
I have had trouble sleeping at night, and chronic fatigue during the day, even after I seem to have gotten enough sleep at night. Some fatigue episodes, when I have woken up well before I should and could not sleep again, have prevented me from driving safely to school and drove me to seek out the HCP listed above, the PMHNP. It started before my vaccination, but seems to have gotten worse (more frequent and more severe) over the past year. She has attributed this to other causes, but I was told by a V-Safe representative that I should report it anyway so the CDC can collect data points. There really isn't a "time course" for this as it's a chronic issue.
Patient noted a history of eczema on the screening form.  The provider reviewed medical records both hard copy and digital and found no documentation of history, nor any prescribed medications for treatment of eczema.  Directed immunizations tech to immunize patient.  Patient denied having any active skin conditions.
Pt recv vax on 9/24/98; on 10/1/98 pt exp erythema multiforme, rash, fever, &irritability.  Pt imp within 3 - 4 wk
The pt experienced a swollen and red left arm. Put cold water on it and was very sore to the touch. Took ASA. The next day was still red, but not as sore.
Fever 99.3 fever, headache. chills. Narrative:  Other Relevant History:
The vaccine was administered at 11:37am. The patient experienced sweating starting at 11:54am. Sweating slowed around 12:03pm. 50 mg of oral diphenhydramine was administered at 12:15pm. Symptoms resolved and the patient left at 12:28pm.
Shooting pain in my head, on and off Sensations of bubbles in my head, like soda Pain in my head, everyday Generally brain fog Bad depression Exhaustion My face lost feeling, couldn?t smile Hard to talk, make a sentence, at times My head hurts, diff from my migraines Pains in my middle, stomach area, shooting Pains in joints Pains in muscles Dizzy Nausea Forgetting things Can?t smile, can?t move face Random rashes popping up on my skin Feeling like I am in a catatonic state Sometimes there is a freezing sensation that hits my feet and hands Feels like all the blood leaving my extremities Herpes sores in my mouth, a lot Could barely work One night I awoke choking on vomit. I was so dead asleep, I guess I vomited and then awoke when I couldn?t breathe.