chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 41-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6201 and Expiry date was not reported), via an unspecified route of administration administered in Arm Left on 20Feb2021 (at the age of 41-years-old) as dose 2, single for COVID-19 immunization. Medical history included, gastroschisis as infant from an unknown date and unknown if ongoing. Concomitant medication(s) included ibuprofen (IBUPROFEN); curcumin (CURCUMIN); colecalciferol (VITAMIN D [COLECALCIFEROL]); magnesium (MAGNESIUM) and daily vitamin all taken for an unspecified indication, start and stop date were not reported.Patient previously received bnt162b2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: 9265 and Expiry date was not reported), via an unspecified route of administration administered in Arm Left on 03Jan2021 at 18:00 as dose 1, single for COVID-19 immunization. The patient previously took lortab [loratadine] and experienced drug hypersensitivity (Known allergies). Patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID-19 prior to vaccination. Post vaccination the patient tested negative for COVID 19. It was reported that on 22Feb2021 21:30, starting on day two patient had shortness of breath. The shortness of breath would last anywhere from 20 to 30 minutes or be fleeting. It was currently day five and still experiencing symptoms. Patient did not received any treatment for the adverse event. The patient underwent lab tests and procedures which included sars-cov-2 test with a nasal swab was negative on 22Feb2021. The outcome of shortness of breath was not recovered.  No follow up attempts are possible. No further information is expected.
Slight tightness in throat, rapid heart beat, occasional slight chest pain, ignored by pharmacist and doctor when asked about it, showed up after first dose and has not gone away
When I went to administer the vaccine the syringe retracted too soon. The patient did not receive the full dose, less than 1/2. I drew up another dose and administered to the the patient.
1 yr old shots given on 5/22/13. Dad noted rash to abd, back, torso, neck primarily; began 6/3/13. No itching, fevers, discomforts associated with many individulized bumps to body. Several are grouping but mostly individual with no centers.
not very effective; not very effective; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A child (patient's age reported as will be 7 y/o in a week and half) male patient received BNT162B2 (COMIRNATY, solution for injection) (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 patient was not immunocompromised. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "not very effective".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200342370 Same reporter, suspect drug and events; different patient
Pain/soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain/soreness at injection site) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No medical history was provided by the reporter.  Concurrent medical conditions included Crohn's disease (moderate to severe adult Crohn's disease).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE PAIN (Pain/soreness at injection site). At the time of the report, VACCINATION SITE PAIN (Pain/soreness at injection site) outcome was unknown.            Treatment medication was not provided. It was unknown if patient was enrolled in COVID-19 Vaccination Trial.  Action taken with mRNA-1273 in response to the event was Not Applicable   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up received on 25-May-2021  does not contain any new information
Chest pain and tachycardia (rates 100s-140s) x 72 hours
Pt vaccinated with MMR had 3 episodes of swelling in testicles & pain in testicles since 24SEP90. Symptoms go away about 2 hrs after onset.
Numbness and tingling in both arms more on left side, up back of neck and to left eye. Redness on both wrists but not at injection site.
pt broke out in fine red rash @ site of MMR & also on trunk; no wheezing or difficulty breathing, but pt very irritable; 10 minutes p/shots; DPH given;
Erythema, warm, non-tender, itchy area approximately 8cmx11cm to right upper arm. No treatment.
injection site warm; big red swatch 2 to 3 inches long from injection site down arm; injection site swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site warm), VACCINATION SITE ERYTHEMA (big red swatch 2 to 3 inches long from injection site down arm) and VACCINATION SITE SWELLING (injection site swollen) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE WARMTH (injection site warm), VACCINATION SITE ERYTHEMA (big red swatch 2 to 3 inches long from injection site down arm) and VACCINATION SITE SWELLING (injection site swollen). At the time of the report, VACCINATION SITE WARMTH (injection site warm), VACCINATION SITE ERYTHEMA (big red swatch 2 to 3 inches long from injection site down arm) and VACCINATION SITE SWELLING (injection site swollen) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable No treatment information were reported.
Aches and pains outside of arm 15 minutes afterwards. Subsided largely, but chills started and became more heightened after strenuous exercise later in the day. After 3 hours of sleep, awoke the next day with chest pain and difficulty moving. Heart rate (normally 60) spiked to 140 and could not see fit five seconds, had to call ambulance. Ambulance determined much of it was due to anxiety (multiple exams and significant work were due soon), and recommended medical supervision to ensure it did not escalate. Went to urgent care and was supervised until 1 pm, 24 hours after the vaccination, by which time symptoms had subsided
Patient developed lightheadedness, nausea, vomiting and headache.  EMS on site evaluated patient and transported to ER for further management.  Associated symptoms include photophobia and dizziness.  Patient administered - ondansetron 4mg iv (EMS-PTA), NS 500ml IV bolus, diphenhydramine 25mg iv, meclizine 25mg po, metoclopramide 10mg iv, excedrin migraine 2 tablets
ACUTE HYPOXEMIC RESPIRATORY FAILURE     9/5/2022 ISCHEMIC CARDIOMYOPATHY W SYSTOLIC HEART FAILURE STAGE C
24h post-injection: tired, injection arm very sore, painful to move 48h post-injection: no symptoms, arm soreness decreased from 36h onwards  64h post-injection: large hive at injection site and smaller hives around injection site; itchy, also body is itchy, mainly head and back (besides injection region), no hives or rash on head, back, or rest of body as of now
Patient with likely osteodysplastic primary dwarfism began to have vomiting, diarrhea, rash, fever on 10/20, became progressively weaker. Seen in urgent care clinic 10/23, became very weak after home on BENADRYL, came to ER. Found to have hydrocephalus (more than previous MRI), decorticate posturing, intubated, ventriculostomy perform, no longer responsive, cerebral edema and herniation.
pt recvd vax yesterday; last noc mom said red blotches-urticarial react;
DIARRHEA; NAUSEA; This spontaneous report received from a patient concerned a 55 year old male. The patient's weight was 390 pounds, and height was 68 inches. The patient's past medical history included benign cranial pherengioma, legally blind, history of multiple shunt revision., sigmoid colostomy, rectal fissure, and neoplasm of unspecified nature of brain, and concurrent conditions included latex allergy, allergy to strawberry, non alcohol user, non smoker, and non drug user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular) dose, start therapy date were not reported for prophylactic vaccination at right deltoid on approximately 26/Mar/2021. The batch number was not reported and has been requested. Concomitant medications included phenoxymethylpenicillin potassium. On 28-MAR-2021, the subject experienced diarrhea. On 28-MAR-2021, the subject experienced nausea. Laboratory data included: Blood test (NR: not provided) Negative for C-Diff, and Stool culture (NR: not provided) Negative for C-Diff. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, and nausea on 29-MAR-2021. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure, since case assessed as non serious
Symptoms started with headache and fatigue.  After a couple of days, developed fever that lasted 3 days.  On the last day of the fever, rash developed all over body and pain around the parotid gland. Two days ago, developed swollen hands and ankles.  Was given antibiotic and told to take OTC allergy medications.
Elevated heart rate; Lightheadedness; Lymphadenopathy; This is a spontaneous report from a contactable consumer. A 56-years old male consumer (patient) reported for himself who received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: EN6201) via an unspecified route of administration on 11Feb2021 at 15:15 in left arm as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. As per the report no other vaccine was administered in four weeks. Covid tested prior vaccination or post vaccination was reported as no. On 11Feb2021 at 15:30, the patient experienced elevated heart rate, lightheadedness and lymphadenopathy. The patient underwent lab tests and procedures on 11Feb2021 which included heart rate as elevated. The outcome of all events was unknown.  No follow-up attempts are possible. No further information was provided.
could not sleep on injection site arm; injection site arm was sore for several days after both shots; I had a headache after one of the vaccinations; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (could not sleep on injection site arm), VACCINATION SITE PAIN (injection site arm was sore for several days after both shots) and HEADACHE (I had a headache after one of the vaccinations) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced INSOMNIA (could not sleep on injection site arm), VACCINATION SITE PAIN (injection site arm was sore for several days after both shots) and HEADACHE (I had a headache after one of the vaccinations). In 2021, VACCINATION SITE PAIN (injection site arm was sore for several days after both shots) had resolved. At the time of the report, INSOMNIA (could not sleep on injection site arm) and HEADACHE (I had a headache after one of the vaccinations) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were provided. No treatment  medication were provided.   This case was linked to MOD-2021-362812 (Patient Link).
Syringe broke as shot was being given. Pt did not get enough vaccine per Dr. 2nd shot given.
Information has been received from a physician concerning a female "between 13 and 15" who in approximately October 2007, was vaccinated with the second dose of Gardasil.  Subsequently, the patient experienced "2 weeks to a month of severe muscle pain and very sleepy mono-like symptoms".  The patient recovered from her severe muscle pain and very sleepy mono-like symptoms.  The patient sought unspecified medical attention.  Lab diagnostic studies included a "mono test and liver test that both results came out fine."  Per the reporter, the patient did not have any adverse reaction with the first dose of Gardasil.  The lot numbers were unavailable and no further information was provided.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 1/15/2008. Information has been received from a physician concerning a 14 year old female who on 14-JUN-2007, was vaccinated intramuscularly with the first dose of GARDASIL (657736/0389U). On 06-SEP-2007 the patient was vaccinated with the second dose of GARDASIL. Also, the patient complained of right hip pain at the time of the second vaccination. On 11-SEP-2007 the patient reported leg and right hip pain. One week later, on 18-SEP-2007 the patient reported having back and hip pain as well as general muscle aches. The patient was also very tired and falling asleep at school and experiencing dizziness. By 25-SEP-2007 the patient was feeling better. Per the reporter, the patient had recovered by 16-OCT-2007. Lab diagnostic studies included a complete metabolic panel, CBC, mon test, liver A1C test, and 2 series of x-rays of the right hip and pelvis. All labs were unremarkable. Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of THINKING ABNORMAL (Have a hard time getting thoughts together/when having a headache and its not treated it scrambles thinking), CONTUSION (Bruising of the arm 24 hours later), HEADACHE (Ongoing moderate to severe headache dosen't go away) and FATIGUE (Shortly after there was fatigue) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21 and 047A21A) for COVID-19 vaccination. Medical history was not provided.  Concomitant products included NIFEDIPINE, GLIMEPIRIDE (AMARYL), VALSARTAN and CEFIXIME (ZIAC [CEFIXIME]) for an unknown indication.On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced THINKING ABNORMAL (Have a hard time getting thoughts together/when having a headache and its not treated it scrambles thinking) and FATIGUE (Shortly after there was fatigue). On 16-Apr-2021, the patient experienced CONTUSION (Bruising of the arm 24 hours later). On 22-Apr-2021, the patient experienced HEADACHE (Ongoing moderate to severe headache dosen't go away). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) for Headache, at a dose of UNK dosage form. At the time of the report, THINKING ABNORMAL (Have a hard time getting thoughts together/when having a headache and its not treated it scrambles thinking), CONTUSION (Bruising of the arm 24 hours later), HEADACHE (Ongoing moderate to severe headache dosen't go away) and FATIGUE (Shortly after there was fatigue) 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. On an unknown date, the patient reported visiting the doctor. Patient also reports with ibuprofen, the headaches came down to 0 or very mild.
Patient was given the pneumonia vaccine, the next day complaining of redness and pain at the site.  According to patient the symptoms lasted 5 days and has now resolved.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Arm responded to it in angry way), VACCINATION COMPLICATION (Did not do well and have to go to bed), VACCINATION SITE WARMTH (Hot), PRURITUS (Itchy) and PERIPHERAL SWELLING (Swollen arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anxiety and Difficulty breathing. Concurrent medical conditions included Post-traumatic stress disorder and Blood pressure increased. Concomitant products included HYDROXYZINE, HYDROCHLOROTHIAZIDE, AMITRIPTYLINE, OMEPRAZOLE, SIMVASTATIN, GABAPENTIN, TRAZODONE and DULOXETINE for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced VACCINATION SITE REACTION (Arm responded to it in angry way), VACCINATION COMPLICATION (Did not do well and have to go to bed), VACCINATION SITE WARMTH (Hot), PRURITUS (Itchy), PERIPHERAL SWELLING (Swollen arm), FATIGUE (Tired) and VACCINATION SITE ERYTHEMA (red). At the time of the report, VACCINATION SITE REACTION (Arm responded to it in angry way) and FATIGUE (Tired) outcome was unknown. Not Provided      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.   Inhalers are used as concomitant drugs and had birdflu in 2011.
Approximately 2 hours post vax pt developed hives, face began to swell, and pt had difficulty breathing.  BP increased and heart rate increased, skin felt like it was on fire. Pt was treated in ER with Benadryl and epinephrine.
No additional AE details provided; Improperly stored administered VARIVAX; Temperature/Time frame: (9.6 C) FOR 80 MINS; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot number: S032356, expiration date: 14-OCT-2021; dose and route of administration not provided). The vaccine was stored in temperature 9.6 degrees Celsius for 80 minutes. There was no previous temperature excursion.  No adverse event was reported.  This is one of the eleven reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA005918: US-009507513-2108USA005926: US-009507513-2108USA005939: US-009507513-2108USA006006: US-009507513-2108USA006030: US-009507513-2108USA006059: US-009507513-2108USA006112: US-009507513-2108USA006125: US-009507513-2108USA006146: US-009507513-2108USA006155:
p/ pt recv vax approx 2yrs later in 1997 pt devel chickenpox
Exessive Crying. Fever 103. Rash/Redness at injection site. Pain in Right Leg (site of injection).
the patient received their first dose of Gardasil on 12/7/2009 and the second dose of Gardasil on 1/4/2010; No adverse effect; This spontaneous report was received from a pharmacy technician refers to a 27 year old patient. Information about patient's concurrent condition, medical history, drug allergy/reaction, concomitant medication was not reported.   On 07-DEC-2009, the patient was vaccinated with first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) and on 04-JAN-2010, the patient was vaccinated with second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (strength, dose, route, anatomical location, lot/batch #, expiration date was not reported) for prophylaxis (inappropriate schedule of product administration). No adverse events were reported. No product quality complaint was involved.
This spontaneous report as received from a healthcare worker (medical assistant) refers to unknown number of patients of unknown age. On unknown dates, time unknown number of patients were vaccinated with VAQTA (lot#, expiration date, dose, frequency, route not reported), that were stored outside of the temperature ranges indicated in the prescribing information. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.