chrisvoncsefalvay/vaers-outcomes huggingface dataset:
flu-like symptoms; knocked down; no appetite; under the weather; had no motivation; fatigue; more than 35 days between first and second dose; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), FALL (knocked down), DECREASED APPETITE (no appetite), ILLNESS (under the weather) and APATHY (had no motivation) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Perforated eardrum (busted ear drums (years ago)), Tinnitus and Cataract. Previously administered products included for an unreported indication: FLU VACCINE VII. Concurrent medical conditions included Diabetes, Arthritis, Carpal tunnel syndrome, Hypertension, Kidney disorder, Heart disease, unspecified, Allergy NOS and Thyroid disorder. Concomitant products included INSULIN for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), FALL (knocked down), DECREASED APPETITE (no appetite), ILLNESS (under the weather), APATHY (had no motivation), FATIGUE (fatigue) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 35 days between first and second dose). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 02-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 35 days between first and second dose) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms) had resolved and FALL (knocked down), DECREASED APPETITE (no appetite), ILLNESS (under the weather), APATHY (had no motivation) and FATIGUE (fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   She stated she takes a lot of medications daily.  She reported that she experienced flu-like symptoms that lasted three weeks after receiving the second dose. She reported she was knocked down and experienced fatigue and no appetite. She stated she was under the weather and wondered what was wrong with her. She reported she also had no motivation. She stated for treatment she took Tylenol. She stated that she did not consider herself immunocompromised, but stated she was high risk for COVID-19 infection.   This case was linked to MOD-2021-325008 (Patient Link).
immediate soreness in arm which has persisted and now leading to decrease range of motion and pain with motion suggests a tendonitis
hives, itching and fever. Parent treated fever at home on 8/25/04. Parent brought child to ER on 8/26/04. Physician prescribed Prednisone (1 tsp every day for 5 days).
pt recv vax & had high pitched screams for 7hr;t100;lt leg swollen more than w/the 1st inj
In monitoring area shortly after vaccination, patient reported to EMS observation staff she was experiencing "lip tingling."  In speaking with staff during assessment, patient's symptoms progressed to c/o lower lip swelling and trouble swallowing. Redness and swelling noted around mouth and nose. IM epinephrine administered at 18:08 and 911 called for transport to hospital.
Massive stroke, given tPA, severe reaction, had to be intubated for 3 days
Tachycardia (120 bpm)  for 5 hours within 24 hours of vaccination following chills and fever. Brief episode of tachycardia ( few minutes) the following day. In both cases, heart rate returned to normal without treatment.
Feeling nauseated/sick to stomach even when waking up. Also had a really bad headache and a rash on stomach. Severe pain with tenderness on her abdomen to the right of her navel along with c/o backpain.
pt recv vax 1995 & 22SEP97, reporter indicated that pt was recently dx w/leukemia & that recent lab eval revealed lack of seroconversion;
I lost my brother due to heart attack we both had same vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 49-year-old male patient received BNT162b2 (BNT162B2), 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: MYOCARDIAL INFARCTION (death, medically significant) with onset Feb2023, outcome "fatal", described as "I lost my brother due to heart attack we both had same vaccine". The patient date of death was unknown. Reported cause of death: "I lost my brother due to heart attack we both had same vaccine". No autopsy was performed.  Clinical Information: last week I lost my brother due to heart attack we both had same vaccine he was 49.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: I lost my brother due to heart attack we both had same vaccine
VACCINE EXPOSURE DURING PREGNANCY; LOW AMNIOTIC FLUID; This solicited pregnancy report received from a consumer concerned a 35 year old female. The patient was enrolled in a non-company sponsored study. The patient's height, and weight were not reported.  The patient's pre-existing medical conditions included: Patient was pregnant at the time of vaccination. Patient was gravida 1 and para 1. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on 07-APR-2021 for covid-19 immunisation. The batch number was not reported and has been requested. Age at time of vaccination 35 years old. No concomitant medications were reported.  At gestational age 25 weeks and three days, the patient received vaccine while being pregnant (vaccine exposure during pregnancy. The date of the patient's last menstrual period was 11-OCT-2020 and and expected delivery date was 18-JUL-2021.  On an unspecified date in year 2021, the patient experienced low amniotic fluid.  On 20-JUL-2021, at gestational age 40 weeks and two days, the pregnancy resulted in a live birth, full-term neonate via caesarean method of delivery (C-section). Primary reason for C-section was reported as low amniotic fluid.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vaccine exposure during pregnancy on 20-JUL-2021, and the outcome of low amniotic fluid was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s and low amniotic fluid, and vaccine exposure during pregnancy as not related. This report was serious (Other Medically Important Condition).  This case was reassessed as serious based on additional information received from consumer on 27-OCT-2021, the following information was updated and incorporated into case narrative: serious event low amniotic fluid added, vaccine exposure during pregnancy was made serious, batch number statement updated, patient delivery details added with outcome of pregnancy, and causality updated.; Sender's Comments: V1 : This follow up adds information about serious event low amniotic fluid added, vaccine exposure during pregnancy was made serious, batch number statement updated, patient delivery details added with outcome of pregnancy, and causality.   20210800933- covid-19 vaccine ad26.cov2.s- vaccine exposure during pregnancy. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.  20210800933- covid-19 vaccine ad26.cov2.s- low amniotic fluid. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered not related.
Patient stated that she had to be hospitalized around 12 hours after receiving this vaccine. She stated she had severe dehydration, fevers, vomiting, that required her to go to the emergency room.
Not 100% certain when adverse event started.  had noticed bruising over last month, but was setting appointment for a routine colonoscopy, and they wanted check blood.  my platelets came back at 45 (on 4 sept).  they thought could be incorrect in test.  tested again (6 sept) and platelets came back at 24.  they told me go to hospital immediately.  a bunch of more tests showed negative for many things.  most everything else in blood within range.   they took blood 6:30 am on 7 september.  platelets came back at 39.  so they let me out of the hospital, but have no understanding of why this happened
This spontaneous report has been received from a Licensed Practical Nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 30-NOV-2017, the patient was inadvertently vaccinated with VARIVAX (dose, route of administration, lot number and expiration date were not reported) instead of ZOSTAVAX for prophylaxis. At the time of this report, no adverse effects were reported in the patient.
Upper respiratory tract something going on; possible bronchitis; Left lower lobe atelectasis; D Dimer that was positive, reading 1.95; Pulmonary embolism; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration at left arm on 21Jan2021 07:30  (62-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included psoriatic arthritis from 10 years (he started Cosentyx three or four weeks before reporting) and COVID virus from Nov2020. Concomitant medications included secukinumab (COSENTYX) from three or four weeks before reporting for psoriatic arthritis. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) via an unspecified route of administration at left arm on 31Dec2020 07:30 (62-year-old at time of vaccination), at single dose, for COVID-19 immunization. Prior vaccinations within 4 weeks was none. Patient states he just wanted to report; and he didn't know if this is significant. Patient reports now he has bilateral pulmonary embolism (from 04May2021) along with an upper respiratory tract something going on. Adds he never had this before. The doctor for his possible bronchitis has him on Omnicef and started Xarelto. Adds they were lucky to find the pulmonary embolism. Mentions the doctor tried a different antibiotic first, Keflex (NDC 68180 0122 02), and it was not helping. The doctor noticed his pulse oximeter (on 04May2021) reading was 92% and did a chest x ray. The chest x ray (on 04May2021) showed left lower lobe atelectasis. The doctor said that would not account for the low pulse oximeter of 92%. She sent him for a D Dimer (on 04May2021) that was positive, reading 1.95; and then had a chest CT at 1:00PM on Tuesday (04May2021), that showed the bilateral pulmonary embolism. Adverse events required a visit to physician office (received outpatient tests). Therapeutic measures were taken as a result of the event possible bronchitis and included Omnicef and Xarelto. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Patient had just received 2 immunizations around 4 pm . Tdap in her left deltoid and Menactra in her right deltoid. Instructed the patient to stay sitting and if she started to feel light headed or dizzy or unwell to lay down. Left the room and within 2 minutes patient's mother came out of the room yelling for help. Staff and I responded. Patient was in the middle of the room lying on her back with her head below our keyboard stand in the room. Staff took patient's oxygen and I went to grab the closest physician. I asked Dr. for help and he went into the room and responded. I stepped out of the room. Staff stayed in with Dr. When patient's PCP Dr. came out of the room I informed her of what happened and that Dr. had went in to check on her. Patient came too shortly after Dr. arrived by the time he had left she was up alert and scared. Dr. briefly informed another Dr. of what happened and Dr. went in with the patient to follow up on the incident.
patient(s) were given dose(s) that were stored in an ultracold freezer which is colder than they should have been, 280 patients received; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (patient(s) were given dose(s) that were stored in an ultracold freezer which is colder than they should have been, 280 patients received) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (patient(s) were given dose(s) that were stored in an ultracold freezer which is colder than they should have been, 280 patients received). At the time of the report, PRODUCT STORAGE ERROR (patient(s) were given dose(s) that were stored in an ultracold freezer which is colder than they should have been, 280 patients received) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.    Most recent FOLLOW-UP information incorporated above includes: On 03-Dec-2021: Reporter details updated.
Post nasal drip, runny nose, chest discomfort, cough. Began two days after injection. Improved after two days, but still have mild symptoms. No fever.
This spontaneous report as received from a pharmacist refers to a 63 years old female patient with opiates allergy. The patient was vaccinated SC. with a dose of ZOSTAVAX (lot number was 0364AE, expired date 16-MAR-2013) on 29-AUG-2012. No other co-suspects were reported. Concomitant medications included clonazepam, ESTRACE, hyoscyamine and VIVELLE-DOT. On 30-AUG-2012 the patient developed a cold sore in her left nostril, headache in her left temple and a left ear pain. No treatment information was reported. No lab diagnostic performed. The patient had called the pharmacy for medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
Fever/Fever was at about 100-101 degrees; general soreness; This is a spontaneous report from a contactable consumer (patient). A 40-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot Number: EN6204), via an unspecified route of administration, administered in Arm Left on 10Mar2021 15:45 (at the age of 40-years-old) as dose 2, single for COVID-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medications included hydrochlorothiazide, lisinopril (LISINOPRIL + HIDROCLOROTIAZIDA), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported. Patient had no known allergies. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: Lot number: EN6201), via an unspecified route of administration, administered in Arm Left on 17Feb2021 03:45 PM as dose 1, single for COVID-19 immunisation. No other vaccine in four weeks. The patient did not tested covid prior vaccination and also not tested covid post vaccination. On 11Mar2021 07:00 AM the patient experienced fever about 100-101 degrees and general soreness. It was reported that events lasted about 30 hours after shot (about 9pm day after, (11Mar2021)). The patient underwent lab tests and procedures which included body temperature: 100-101 degrees. No therapeutic measures was taken. The outcome of events was recovered on 11Mar2021.  No follow-up attempts are possible. No further information is expected.
Patient developed myocarditis with peak troponin of 6.4, normal echo. He required hospitalization for evaluation and management of pain.
Crying inconsolable. Swelling of thigh (left) knee to hip, hot to touch. Shots given at about 1040a. Still crying presently 3pm.5/13/09-records received for DOS 5/6-5/7/09 DC DX: Resolved fussiness. Presented with C/O inconsolable crying for almost 6 hours. PE: fussy and inconsolable. Local reaction on left thigh at site of Pentacel.  6/19/09 ICD-9 codes received DOS 5/6/09 782.2 Local Superficial, E948.6 Adv Eff Perussis Vaccine.
Severe abdominal pain. Nausea/vomiting. Severe left side body pain.
DIZZINESS; VOMITTING; FEELING HOT; FEELING COLD; This spontaneous report received from a consumer concerned a Asian female of unspecified age (Hispanic/Latino). The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, expiry: UNKNOWN) .5 ml, 1 total, administered on 08-MAR-2021 to Right Arm for prophylactic vaccination. No concomitant medications were reported.  On 09-MAR-2021, the patient experienced dizziness, vomitting, feeling hot, and feeling cold. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, vomitting, feeling hot, and feeling cold. This report was non-serious.
pt devel herpes in the nose area which subsequently extended to the eye; since receiving the vax pt has been off from work numerous times w/bronchitis;
Patient administered Fluzone in right deltoid on 11/13/01. 36 to 48 hours began with severe pruritis, small raised lesions after itching began. No red, just raised began at the site on right arm but developed and spread distally. Then erupted in various locations such as right leg to cover 80% of his body. It is worse at night and still persists. Doctor has tried antihistimines. Solumedrol dose pack. Going to see dermatologist on 12/10.
11AUG97 pt recv vax 19AUG97 devel fever 22AUG;pt devel raised rash on trunk & back only lasted x 2-3 days fussy-no appetite 25AUG97 fever & rash gone;tx w/APAP for fever per mom;
This case was reported by a other health professional and described the occurrence of expired vaccine used in a 2-month-old unk patient who received PEDIARIX (batch number unknown, expiry date 23rd October 2014). On 13th November 2014, the patient received PEDIARIX (unknown). On an unknown date, an unknown time after receiving PEDIARIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional information: No adverse event was reported.
Case number PHEH2015US009940, is an initial spontaneous report from a physician received on 21 May 2015. This report refers to a 12-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with MENVEO (batch number: not reported) on 09 Oct 2014 and again received MENVEO (batch number: M14125) intramuscularly on 18 May 2015 erroneously. No adverse event was reported.
65-year-old with history of TBI and end-stage renal disease subsequently initially admitted to the floor secondary to fever and chills. Found to have COVID-19 pneumonia. On June 13 a rapid response was called for worsening respiratory failure. Subsequently transferred to ICU. Initially on CPAP at 100% FiO2. CTA negative for PE but did show diffuse ground glass infiltrates. Completed 10 days of dexamethasone. Not a candidate for remdesivir given end-stage renal disease. Additionally on cefepime and Rocephin for 10 days subsequently restarted on meropenem.  Fortunately patient continued to have hypoxemia unresponsive to noninvasive ventilation. He was intubated on June 19. At the time of intubation he expresses desire not to be intubated for an extended period of time. Unfortunately they are unable to wean from ventilator. Remains on 100% FiO2 with PEEP of 18 and was on nitric oxide. In addition was on paralytics. Remained on prednisone taper off of dexamethasone.  In addition to above patient had complications A. fib with RVR further complicated by hypotension. Was on 3 pressors. Suspect multifactorial to sedation and patient with severe Covid who also has end-stage renal disease. SLED initiated while in-house.  On the afternoon of June 23 palliative team did meet with patient's siblings. That time determined to transition to comfort care. Compassionate extubation performed. Patient passed away shortly after extubation.  Patient died of COVID-19 despite being fully vaccinated against it.   Death Certificate Information:  Part I: Cause of Death A. Respiratory Failure B. Pneumonia C. COVID-19 Part II Other Significant Conditions: Hypertension, Diabetes Mellitus Type 2, End Stage Renal Disease
Red, warm arm, painful. Went to MD, who diagnosed with cellulitis and prescribed KEFLEX 250
On Monday, Jan 17, I had slight warmth and swelling at the injection site on my right arm. By evening, it was quite warm, and the skin felt very tight. It began to itch. On Tuesday, Jan 18, my arm was hot to the touch, visibly swollen, and had a splotchy redness unevenly around the injection site. It was itching a little more. On Wednesday, Jan 19, my arm continued to be hot to the touch and visibly swollen, though the redness had gone down slightly. The itching was more intense, and I used an off brand version of Benadryl Itch Relief Spray paired with ice packs on the injection site. This brought a lot of relief. Today, Jan. 20, it is still hot to the touch, but the swelling has gone down considerably, and only a small (quarter size) amount of red blotchiness remains. The itch is still intense, and I am continuing to use ice packs and the itch spray for relief. I had no fever throughout this event. I had normal (for me) aches and pains in my joints.