chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient became ill 4 days after second vaccination and was hospitalized.; This is a spontaneous report from a contactable consumer reported for himself.   An adult male patient received the second dose of BNT162B2 (BNT162B2), 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 the patient's concomitant medications were not reported.  The patient became ill 4 days after second vaccination and was hospitalized for 4 days. The outcome of the event was recovering.  A treatment was performed for the event. The event was considered serious life threatening.  Information on the lot/batch number has been requested
Information has been received from a consumer concerning her daughter in law who on 04-JUN-2012 was vaccinated with her first dose of GARDASIL (lot # not reported). The reporter was very upset that her stepdaughter a senior in high school, had had syncope, "passed out," and a seizure while still in the doctor's office after receiving the vaccine on 04-JUN-2012. The caller reported that the physician did not think the symptoms were related to the vaccination. On 05-JUN-2012, the child had a "terrible headache" and needed to leave school and return home. The doctor had recommended that the child sought a neurologist but the reporter was asking why. At the time of the report, the patient's outcome was unknown. No further information is available.
I felt very weak; had diarrhea; I started to feel dizzy,; and vomiting; my arm was very sore; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (had diarrhea), DIZZINESS (I started to feel dizzy,), ASTHENIA (I felt very weak), VACCINATION SITE PAIN (my arm was very sore) and VOMITING (and vomiting) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included AMLODIPINE for an unknown indication.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced VACCINATION SITE PAIN (my arm was very sore). On 23-Feb-2021, the patient experienced DIARRHOEA (had diarrhea), DIZZINESS (I started to feel dizzy,) and VOMITING (and vomiting). On 24-Feb-2021, the patient experienced ASTHENIA (I felt very weak). At the time of the report, DIARRHOEA (had diarrhea), DIZZINESS (I started to feel dizzy,), ASTHENIA (I felt very weak), VACCINATION SITE PAIN (my arm was very sore) and VOMITING (and vomiting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Tested positive for COVID on 01/07/2022. 01/09/2022 I went to the ER and I was sent home. 01/11/2022 I wasn't really responsive, and an ambulance was called because my heart beat had gotten down to 35 bpm. I was taken away by ambulance and they had to defibrillate me multiple times before I got into the ER. My blood sugar was at 546 and I was in the ICU for 4 days. I came home and I have had physical therapy and been trying to get my strength back walking for about a month. I tried getting my blood sugar back under control and I did increase glimepiride to 4 mg but I'm still not able to get it under control yet. I also had tachycardia and cardiogenic shock and an irregular heartbeat, and the tachycardia and irregular heartbeat has dissipated. My average blood sugar right now for 14 days is 166 and I'm trying to control my eating and I'm averaging 113 carbs a day. My projected A1C right now is 713. I also had shortness of breath.
Red raised spot at injection site "COVID Arm" Inflamed Lymph notes in my armpit of the injection site Fatigue Chills
This spontaneous report was received from an administrator reporting on multiple patients of unknown age or gender. No information regarding the patients' pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (doses, route of administration, lot numbers or expiration dates were not reported), for prophylaxis. The temperature excursion ranged from 0 to 1 degree Celsius and lasted for 57 hours 25 minutes. It occurred once on an unspecified date and was detected by a Digital Data Logger. There was no previous excursion reported. No adverse effects were reported. This was one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA004568: US-009507513-1706USA002610:
INJECTED PATIENT WITH PFIZER BIVALENT BOOSTER DOSE INSTEAD FOR FIRST FULL DOSE OF PFIZER COVID VACCINE.
24 hours after I received my @ shot .I started having the chills which lasted 4 hours. This next morning I passed out cold and hit a Table in my living room and a Metal plate went through my top lips and Broke my teeth. The plate went all the way through.
Rash; Lymph nodes were swollen; Swelling on her face, ankle; Swelling on her face, ankle; Lymphatic bumps all over her clavicle, elbow, thigh, knee; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced rash, lymph nodes were swollen, swelling on her face, ankle and lymphatic bumps all over her clavicle, elbow, thigh, knee. Patient asking how long will the vaccine last in regards to efficacy of a single dose. Patient stated her doctor told her she should wait for her 2nd dose because she broke out in a rash, her lymph nodes were swollen, she had swelling on her face, ankle, and below her elbow she had a rash there. They recommended her to wait for 2nd dose. Patient stated she had lymphatic bumps all over her clavicle, elbow, thigh, knee. An ultrasound was done and the HCP stated it was lymphatic. Patient stated the bumps were 3-4 inch bumps like huge soft plums. Patient asking if anybody has reported lymphatic bumps and swelling 3 to 4 inches. Patient stated she read something about T-cells that will have the memory to fight off Covid. T-cells will recognize the Covid virus and will have a memory on it and will be able to fight it. Patient is asking what does your study say about T-cells about recognizing and being able to fight it again. Patient also wondering if Pfizer is in the works of making a booster shot. Has Pfizer provided a statement on the need for a booster dose (3rd dose). Is Pfizer investigating the need for a booster dose. Patient stated her doctor told her to wait for her second dose and it's been almost over 42 days. Patient is wondering if she needs to restart. Verbatim and Event Description: swap from FC- Patient stated she got her 1st dose of the vaccine and she was tested for anti-bodies. She broke out with bumps under her elbow, swelling on her face, her lymph nodes. Patient wants to know how long does this vaccine last after the anti-bodies fade away. Her doctor told her to wait to get the 2nd dose. She wanted to know if just the one dose will protect her. The patient underwent lab tests and procedures which included antibody test was unknown and ultrasound was abnormal (lymphatic) on an unspecified date. The outcome of all the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 22-MAY-2018, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # N022167, expiration date: 08-FEB-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA001505: US-009507513-1806USA009026: US-009507513-1806USA009027: US-009507513-1806USA009028: US-009507513-1806USA009029: US-009507513-1806USA009030: US-009507513-1806USA009031: US-009507513-1806USA009032: US-009507513-1806USA009033: US-009507513-1806USA009034: US-009507513-1806USA009035: US-009507513-1806USA009036: US-009507513-1806USA009037: US-009507513-1806USA009038: US-009507513-1806USA009039: US-009507513-1806USA009040: US-009507513-1806USA009041: US-009507513-1806USA009042: US-009507513-1806USA009043: US-009507513-1806USA009044: US-009507513-1806USA009045: US-009507513-1806USA009046: US-009507513-1806USA009047: US-009507513-1806USA009048: US-009507513-1806USA009050: US-009507513-1806USA009051: US-009507513-1806USA009052: US-009507513-1806USA009053: US-009507513-1806USA009054: US-009507513-1806USA009055: US-009507513-1806USA009056.
w/in 6hr devel sore throat & tightness in throat, T103.4, h/a, arms & legs achy & tight;
Flushing, possible rash/hives, vision changes. Allergy medication  given at test site.  Transported to ER for observation. Given Decadron and Pepcid.  Observed and discharged.
LOSS OF APPETITE; NECK ACHE AT BASE; FELT HOT TO THE TOUCH; CHILLS; HEADACHE, IT WAS LIKE WHOLE HEAD HURT ALL OVER AND BACK OF HEAD; A LITTLE BIT OF NAUSEA FEELING; A LITTLE TIREDNESS BUT NOTHING EXTREME; SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user, non smoker, and sulfa allergy, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, and expiry: UNKNOWN) dose was not reported, administered on 16-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced shortness of breath. On 17-AUG-2021, the patient experienced loss of appetite. On 17-AUG-2021, the patient experienced neck ache at base. On 17-AUG-2021, the patient experienced felt hot to the touch. On 17-AUG-2021, the patient experienced chills. On 17-AUG-2021, the patient experienced headache, it was like whole head hurt all over and back of head. On 17-AUG-2021, the patient experienced a little bit of nausea feeling. On 17-AUG-2021, the patient experienced a little tiredness but nothing extreme. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, loss of appetite, neck ache at base, chills, headache, it was like whole head hurt all over and back of head, a little bit of nausea feeling, and a little tiredness but nothing extreme on AUG-2021, and the outcome of felt hot to the touch was not reported. This report was non-serious.
Multiple gray scale and color Doppler sonography images detected kidney cysts measuring 2.3cm, 1.6cm, and 1.1cm on the right kidney.  There is a 0.6x0.7x0.7cm hypoechoic mass on the left kidnet.
allergic reactions; rash, itching, hives, and swelling of the face (specifically eyes)
rash appearing on my arm yesterday where I got the vaccine; soreness; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (rash appearing on my arm yesterday where I got the vaccine) and INJECTION SITE PAIN (soreness) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Injection site rash on 17-Feb-2021 and Pain injection site on 11-Feb-2021.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced INJECTION SITE PAIN (soreness). On 17-Feb-2021, the patient experienced INJECTION SITE RASH (rash appearing on my arm yesterday where I got the vaccine). On 12-Feb-2021, INJECTION SITE PAIN (soreness) outcome was unknown. At the time of the report, INJECTION SITE RASH (rash appearing on my arm yesterday where I got the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment and concomitant product use were not provided by the reporter.
her arm is sore and hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (her arm is sore and hurting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (her arm is sore and hurting). At the time of the report, PAIN IN EXTREMITY (her arm is sore and hurting) had not resolved.            Concomitant products were not provided.  Patient stated that she had blood work done and her results are not same as before.  Treatment medications were not reported.   Reporter did not allow further contact
Headache, Fever, NauseaVomiting,  STABBING PAIN FROM FEET TO HEAD UPON STANDING
Fever at 101 degrees; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 12 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 21Oct2021 17:00 (Lot number: FH8020) at the age of 12 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergy: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: FLU taken for immunisation, administration date 18Oct2021. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FF2587, Location of injection: Arm Left, Vaccine Administration Time: 17.00, Route of Administration: Intramuscular), administration date: 30Sep2021, when the patient was 12 years old, for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 22Oct2021 07:00, outcome "unknown", described as "Fever at 101 degrees". The patient underwent the following laboratory tests and procedures: body temperature: (22Oct2021) 101 degrees. Therapeutic measures were not taken as a result of pyrexia.  Additional information: Other vaccine 4weeks product Flu vaccine was taken. The patient had not covid prior vaccination. The patient had not covid tested post vaccination.    No follow-up attempts are possible. No further information is expected.
pt recvd vax; swelling in arm, hives, "fever in it", weighty arm; no resp for request for info from employer;
Itchy hives secondary to shingles vaccine four days after the immunization. She treated with chamomile cream and Benadryl with relief to symptoms. Hives initially developed to her right arm which spread to her trunk, specifically to her anterior chest and beneath her bra strap on her right side.
Guillan Barre.  11/2/09 ED and Hospital records received service dates 10/26/09, 10/28/09 to 11/1/09. Assessment: Symptoms consistant with Guillain-Barre syndrome varient involving essentially the sensory system. Patient has had cold-like illness, fever, coughing, sore throat, and progressive weakness of a weeks duration. Treated symptomatically for viral illness. Numbness feet and hand. Tired, sleeping a lot, headache, congestion, acute sinusitis. Weakness has increased in both legs. Difficulty walking. Stiffness in neck. Presented at ER with difficulty breathing, evaluated, and sent home. Now presents with nausea, difficulty swallowing, flat affect, sad looking.
Rapid onset of symmetrical upper body tingling, numbness in extremities, neck and face and intense tremors in hands. Symptoms appear to have predominately resolved within approximately 45 minutes with some residual weakness and mild paresthesias ongoing at time of this report.
A non-serious spontaneous report of administration of expired dose of FLUMIST was received from a healthcare professional concerning a 32-month-old male. The product expired on 04-Jan-2010. On 13-Jan-2010, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with manufacturer's post marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated  that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec 2021, Jan 2022, and Feb 2022. It was reported that the patients have been administered doses while the temperature excursion assessment was ongoing and reported that no adverse reactions were reported by any patients. No treatment medications were reported
The patient Is a 62-year-old man with history of COPD and granulomas disease, who presents with  With trouble maintaining attention at home.  Patient explains that he was diagnosed with COVID on the 30th of August.  He received an antibody infusion yesterday.  Today home monitoring RN noticed that his oxygenation was dropping that to 90, and recommended that he come in.   The patient explains that he has been feeling very short of breath, especially when walking.  He also reports that he has with 4/10 pain when he takes a deep breath.  He has not been using any oxygen at home he, and he has been able to take in adequate oral intake.  He has been coughing up white sputum without blood, and has some abd pain, fever
Highest temp measured 104.4, local rxn @ inject site, alteration in level of consciousness;
This report is being  filed due to 3rd dose provided too early (4 months early to patient).  This is a healthcare worker not eligible until 6 months status post 2nd injection
pt cried for 15-20 mins cried & stopped for 15 mins; then would start again from 2PM-7PM; took formula poorly;
Information has been received from a registered nurse concerning a 24 year old female who on 05-NOV-2010 was vaccinated IM with the first 0.5 ml (also reported as 0.5 mg) dose of GARDASIL (lot # not provided, expired date 12-NOV-2012). Concomitant therapy included multi-vitamins. On 05-NOV-2010 the patient fainted or passed out for five to ten seconds after her first dose of GARDASIL was administered.  The patient was fine after resting for thirty minutes after the injection. The nurse reported that the physician had not heard from the patient after the procedure and said the patient was fine when she left the healthcare office. It was reported that therapy with GARDASIL was discontinued. The patient sought unspecified medical attention. Follow up information received from the registered nurse indicated that the patient was a female, with drug allergies to hydrocodone and no illness at time of vaccination, who on 04-NOV-2010 (previously reported by the registered nurse was 05-NOV-2010) at 9:00 am was vaccinated IM with the first dose of GARDASIL (lot # 666598/0786Z) at right deltoid. Seconds after administration of GARDASIL patient complained of lightheadedness and was assisted to lay back on table she was sitting on. Patient lost consciousness for approximately 10 seconds. Shortly after, patient stated she "felt fine". Vitals were stable. Patient rested in office approximately 20 minutes. Then she had someone drive her back to work. At the time of reporting, the patient's status was recovered. No further information is available.
3-4 DAYS AFTER INJECTION NOTED  OF NAUSEA, MILD ABDOMINAL DISCOMFORT,  GENERALIZED HEADACHE LASTING A COUPLE OF HOURS.  HEADACHE MORE SEVERE AT FIRST AND GRADUALLY RESOLVED.      WHILE THIS WAS GOING ON patient  NOTED LOSS OF   VISION ON LEFT LATERAL VISUAL FIELD   INVOLVING  LEFT EYE ONLY.   THIS LASTED 30-40 MINUTES .   IT WAS NOT NOTICED TILL AFTER THE OTHER SYMPTOMS HAD BEEN THERE FOR A WHILE AND MIGHT HAVE BEEN THERE LONGER AS THE VISION FROM THE RIGHT EYE WAS OK AND  HE HAD TO COVER THE RIGHT EYE TO APPRECIATE THE DEFECT.