chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Thumb joint on right hand. Severe pain and swelling. Unable to grip anything with right hand due to inability to bend thumb.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age. The patient's pertinent medical history and concomitant medications were not reported. On 03-APR-2015, the patient was vaccinated with an improperly stored doses of GARDASIL (dose and route were not reported;lot # K006191, expiration date 02-FEB-2017). There were no adverse experiences reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt reported difficulty breathing, "itchy" throat, and flushing. Pt assessed and monitored for worsening reaction. Pt advised to go to urgent care if symptoms become worse.
Soreness on the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness on the injection arm) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-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 an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness on the injection arm). At the time of the report, VACCINATION SITE PAIN (Soreness on the injection arm) outcome was unknown.            No Concomitant product use was reported.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.
(L) arm swelling with 5th dose of DTaP - discussed normal mild reaction. Mom still asked that it be reported.
Extreme headache, stomach upset, body aches, extreme bone pain in legs, nasal congestion, chest congestion
Patient tested positive for Covid 19 on 9/23/2021.  Patient was residing at assisted living facility.  On 10/03/2021 patient was found unresponsive in bed, no pulse, no breath.  Due to code status of DNR, code blue was not called.
Fever, dizziness, weakness, trouble walking, full body aches, headache, wheezing, difficulty breathing, rapid heartbeat, high fever, cough, shortness of breath, vomiting, heartburn, earaches (pressure in the ear), chills, extreme night sweats
Warm; Itchy; Small, patch mark or rash that appeared about 1 inch down her arm from her injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (Warm), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE RASH (Small, patch mark or rash that appeared about 1 inch down her arm from her injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A22A, 065F21A, 007C21A and 042B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 50 microgram. On 23-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 50 microgram. On 24-May-2022, the patient experienced VACCINATION SITE WARMTH (Warm), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE RASH (Small, patch mark or rash that appeared about 1 inch down her arm from her injection site). At the time of the report, VACCINATION SITE WARMTH (Warm), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE RASH (Small, patch mark or rash that appeared about 1 inch down her arm from her injection site) was resolving.            No concomitant medication was reported.  Patient did not experience any symptoms after the first 3 doses of the vaccine.   The day after the dose on 23-May-2022, patient started to experience a warm, itchy, small, patch mark or rash that appeared about 1 inch down arm from injection site. Patient has not taken any medications or treatments to try and help with that. It has been getting smaller since it started, but has not resolved.
Patient fainted within a few minutes of the shot being administered. She began to slide off the exam table but the doctor & I caught her. When we brought patient to the floor, her right eye started blinking rapidly and she grabbed my hands. She appeared to be awake, but she shouted something to her brother who was not in the room. The doctor and
Pain left arm - site swollen - site red but could be from vaccination application - patient unsure - no elevated temperature.  12/19/2002 - Arm continues to be sore - Continue with IBA Prophen
injection arm hard as a rock; injection arm swelled; injection arm hurt; Welt like marks on arm; flu like symptoms; fever; chills; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INDURATION (injection arm hard as a rock), PERIPHERAL SWELLING (injection arm swelled), PAIN IN EXTREMITY (injection arm hurt), URTICARIA (Welt like marks on arm) and INFLUENZA LIKE ILLNESS (flu like symptoms) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sinusitis (Sinusitis 56Years), Drug allergy (Sulfar allergy), Food allergy (Pepper allergy), Food allergy (Chilli pepper allergy), Food allergy (Red pepper allergy), Food allergy (Jalapeno Pepper allergy) and Food allergy (Cayenne Pepper allergy). Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) from 23-Feb-2016 to an unknown date for Cholesterol, PHENOBARBITAL from 1966 to an unknown date for Epilepsy, AMLODIPINE from 23-Feb-2016 to an unknown date for Heart disorder, ACETYLSALICYLIC ACID (ASPIRIN 81), RHAMNUS PURSHIANA BARK (CASCARA SAGRADA BARK) and IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced INDURATION (injection arm hard as a rock), PERIPHERAL SWELLING (injection arm swelled), PAIN IN EXTREMITY (injection arm hurt), URTICARIA (Welt like marks on arm), INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache). On 23-Mar-2021, INDURATION (injection arm hard as a rock), PERIPHERAL SWELLING (injection arm swelled), PAIN IN EXTREMITY (injection arm hurt), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache) had resolved. On 28-Mar-2021, URTICARIA (Welt like marks on arm) and INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved.            Urticaria and Influenza like illness events are recovered on 25-MAR-2021 but they are recovered on 28-MAR-2021 with Residual effects like Hard arm and Swollen arm. Treatment information was not provided.  The action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Follow up document was received. Patient demographic details, vaccine information, medical history, concomitant Medications were updated. New event added. It contains significant information.
9 days p/vax pt devel an area of necrosis near the site of vax;this area of necrosis was encircled by a red ring;tx w/pred for 1 wk w/mild reduction of the inflammation;then tx w/ATB;western blot test for lyme disease was positive;
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter was infection control manager.  Concomitant medication of the patient was not reported.  Date the vial was placed in the refrigerator was 08-NOV-2021. There was no temperature excursion. The reporter reported that that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned.  The patient did not experience any adverse event.  No treatment information was provided by the reporter.
10/25 Immunizations -> followed by 1-2 days of fever 1 week later restarted fever to 102 fatigue & diarrhea (seen 11/2). 11/4 Became more lethargic. Lost milestone, then started infantile spasms. Diagnosed by neurologist.
after receiving vaccine, felt tired, had runny nose on 4/5/21 visited patient around 10am, told us she was going to see the doctor next day 4/6/21 called patient 3x and no one picked up learned that patient suffered from stroke sometime prior night, learned that from sister (approximately 12 hours before patient was discovered in her home) - 911 called and rushed patient to ER patient spent time in ICU, conditioned stabled - continues to stay in hospital, condition continues to be monitored
Itchy, blister-like rash appeared on legs & torso two weeks after 2nd Pfizer vaccine.  Lasted about three weeks.   Had a telehealth visit with a nurse practitioner in a dermatologist's office, however she was unable to diagnose the issue.  When the rash continued to flare, my primary care doctor was eventually contacted, but by the time an appointment could be scheduled, the rash had cleared up.  Based on a description of the symptoms, Dr. suspected that it was a mild case of Shingles because of my immune system issues.  The recommendation was to wait a few weeks and to get the Shingrix vaccination ahead of any future COVID vaccinations.
Eczema/Eczema on legs; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (Eczema/Eczema on legs) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Rheumatoid arthritis: RINVOQ (Route -Oral.). Past adverse reactions to the above products included No adverse event with RINVOQ.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, the patient experienced ECZEMA (Eczema/Eczema on legs). At the time of the report, ECZEMA (Eczema/Eczema on legs) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, SARS-CoV-2 antibody test: negative (Negative) Negative. On an unknown date, Blood test: no antibodies No antibodies to the covid 19 vaccination.         It was unknown whether patient was enrolled in covid-19 vaccine trial.  The reporters causality for the event Eczema/Eczema on legs with RINVOQ was reported has no reasonable possibility.  Concomitant drugs were not reported.  Treatment details were not given
This spontaneous report was received from a nurse, referring to 40 unspecified patients of unknown gender and age. No information regarding the patients' concomitant medications, pertinent medical histories and drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # N004799, expiration date: 15-NOV-2019 (dose and route of administration were not reported). No adverse effects were reported. It was reported that the vaccines were exposed to the temperature of 12.2 Celsius degrees for a time frame of 37 minutes. The temperature excursion was recorded by a digital data logger and the previous excursion was reported as 9.3 Celsius degrees for 16 minutes for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1708USA008138: US-009507513-1708USA008139: US-009507513-1708USA008140: US-009507513-1708USA008141.
This spontaneous report as received from a health care worker refers to an unspecified number of patients of unknown age and gender. Information regarding the patients' pertinent medical history, drug reactions/allergies and concomitant medications was not reported. On unspecified dates, the patient were vaccinated with improperly stored doses of VAQTA (lot number and expiration date, dose and route of administration were not reported). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Received vaccine during breastfeeding; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Received vaccine during breastfeeding) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    MEDICAL HISTORY (Parent): Concurrent medical conditions included Maternal exposure during breast feeding.    No Medical History information was reported.   In March 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 an unknown date, the patient experienced EXPOSURE VIA BREAST MILK (Received vaccine during breastfeeding). At the time of the report, EXPOSURE VIA BREAST MILK (Received vaccine during breastfeeding) had resolved. Not Provided          No Concomitant medicines were provided.  No Treatment medicines were provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Updated Month of Vaccination
Pt admitted due to suspected post surgical-leak from a gastric sleeve surgery done.  Pt transferred from where she was found to be COVID positive.
SKIN ABRADED; AWAKE LAST NIGHT BECAUSE OF INTENSE ITCHING; ITCHING OF KNEECAP, QUAD, LOWER QUAD ON BOTH LEGS, BOTH SIDES OF HIP NEAR PELVIC BONE, BICEP, LOWER ABDOMEN; REDNESS OF KNEECAP, QUAD, LOWER QUAD ON BOTH LEGS, BOTH SIDES OF HIP NEAR PELVIC BONE, BICEP, LOWER ABDOMEN; This spontaneous report received from a patient concerned a 48 year old male. The patient's weight was 178 pounds, and height was 69 inches. The patient's concurrent conditions included alcohol user, non smoker, and eczema, and other pre-existing medical conditions included the patient had no known allergy. The patient was normally healthy, had no medical conditions. The patient took no medications. The patient did not have any history of drug abuse or illicit drug use. The patient took vitamin b for men. The patient was previously treated with alprazolam, and zinc. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 04-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-JUN-2021, the subject experienced itching of kneecap, quad, lower quad on both legs, both sides of hip near pelvic bone, bicep, lower abdomen. On 12-JUN-2021, the subject experienced redness of kneecap, quad, lower quad on both legs, both sides of hip near pelvic bone, bicep, lower abdomen. On an unspecified date, the subject experienced skin abraded, and awake last night because of intense itching. Treatment medications (dates unspecified) included: cortisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itching of kneecap, quad, lower quad on both legs, both sides of hip near pelvic bone, bicep, lower abdomen, and redness of kneecap, quad, lower quad on both legs, both sides of hip near pelvic bone, bicep, lower abdomen, and the outcome of skin abraded and awake last night because of intense itching was not reported. This report was non-serious.
hot; injection site swelling; injection site red; injection site pain; hard at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot), VACCINATION SITE SWELLING (injection site swelling), VACCINATION SITE ERYTHEMA (injection site red), VACCINATION SITE PAIN (injection site pain) and VACCINATION SITE INDURATION (hard at the injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concomitant products included HYDROCODONE, LEVOTHYROXINE, METFORMIN, OMEPRAZOLE, VARENICLINE TARTRATE (CHANTIX), TROSPIUM, FLUOXETINE HYDROCHLORIDE (PROZAC), ROPINIROLE, CALCITRIOL and CALCIUM CITRATE for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE WARMTH (hot), VACCINATION SITE SWELLING (injection site swelling), VACCINATION SITE ERYTHEMA (injection site red), VACCINATION SITE PAIN (injection site pain) and VACCINATION SITE INDURATION (hard at the injection site). At the time of the report, VACCINATION SITE WARMTH (hot), VACCINATION SITE SWELLING (injection site swelling), VACCINATION SITE ERYTHEMA (injection site red), VACCINATION SITE PAIN (injection site pain) and VACCINATION SITE INDURATION (hard at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Problems started with a sore throat and burning mouth for 2 months. Soreness developed into painful mouth ulcers. Admitted to hospital  in June 2021 and diagnosis is still unknown. Doctors believe it could be behcets syndrome or another autoimmune disease that is unknown at this time. I was on corticosteroids for 4 months. Recently started taking Otezla to treat mouth ulcers and stopped taking steroids, treatment seems to be keeping mouth ulcers away at this time. I recently had a small stroke on November 5th 2021 and was hospitalized for 3 days.
8YO received Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-year-old female patient who received DTPa-IPV (Kinrix) (batch number C472T, expiry date 22nd March 2024) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included DTaP vaccine (receive 4 doses of DTaP vaccines and 4th dose was administered at 18 months) and IPV vaccine (receive 3 doses of IPV vaccine).   On 14th February 2023, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 14th February 2023, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-Feb-2023 Reporter's Comments: Medical Assistant reports 8 year old female patient was behind on DTaP and IPV vaccines came in to the office on 14th Feb 2023.   The patient had had four prior DTaP vaccines, with the fourth dose being at 18 months of age.   In an attempt to get the patient caught up, they administered a dose of Kinrix on 14th Feb 2023.  The dose of Kinrix given was the patient's fourth dose of IPV. Additional Supportive Information: The patient was administered with Kinrix vaccine, which was at age of 8 years, which led to Inappropriate age at vaccine administration
20min post injection patient developed a rash on the left lateral abdomen, folled by HIVES and spreading up to the left ear.with in 10 minutes  Patient then became nuaseated and started coughing every 30 seconds, .30 Epi delievered via auto injector to the left lateral thigh. Patient was monitored and transported to hospital.
The vaccine was administered to a patient outside of the approved age range. The patient is 18 years and 6 months old. Vaccine is for adults 19 years and older.
No adverse rx or events reported at time of this author's note. Pt has been seen by his PCP since administration of vaccine for a pre-op physical.  Nothing was noted in office note.
Right auxiliary edema extending to right pectoral muscle and lymph node swelling; Right auxiliary edema extending to right pectoral muscle and lymph node swelling; This is a spontaneous report from a contactable Pharmacist (patient)  A 44-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Right on 10Feb2021 15:30 (Batch/Lot number was not reported) as second  SINGLE DOSE for covid-19 immunisation.Age at vaccination :44 years. The patient received the first dose at age of 44 years on 23Jan2021 at 4:00 p.m . No other vaccine in four weeks .The patient medical history was not reported. Concomitant medication(s) included fish oil (FISH OIL) taken for an unspecified indication, start and stop date were not reported.  The patient experienced right auxiliary edema extending to right pectoral muscle and lymph node swelling on 12Feb2021 with outcome of not recovered.No treatment received. No COVID prior vaccination.No COVID tested post vaccination.  No follow up attempts are possible, information about lot/batch number cannot be obtained.
"Following the flu shot I have had pain in the shoulder joint when I raise my arm up or across."
REALLY RED SKIN; BUMP ON ARM (UNDERNEATH SKIN); SORE ARM (MUSCLE ACHE); This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on left arm on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-MAR-2021, the subject experienced bump on arm (underneath skin). On 15-MAR-2021, the subject experienced sore arm (muscle ache). On 17-MAR-2021, the subject experienced really red skin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from really red skin, bump on arm (underneath skin), and sore arm (muscle ache). This report was non-serious.
9/13/07 Pt has skin lesion x 2 days; sore x swollen at site Tdap given 9/7 Appears infected, aggravated by exertion. given Keflex 500 mg #40, 2 tablets every 12 hours with food.
Day 9 post vaccine and have a rash at injection site as well as sore muscle where injection was given.
Pt recvd. 1st vax on 4JUN91 next day developed severe h/a, migraine which was tx w/aspirin, Sudafed;6JUN81 rapid onset eczematoid rash; Next day apparent allergic dermatoses, SOB, pharyngeal tightness, Hospitalized x 1 day;
Redness, swelling around injection site on left arm. Patient mentioned the area was itching.