chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Solid red at injection site; Slightly swollen at injection site; Slightly itchy at injection site; Rash 0.5-2 inches in diameter; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash 0.5-2 inches in diameter), VACCINATION SITE ERYTHEMA (Solid red at injection site), VACCINATION SITE SWELLING (Slightly swollen at injection site) and VACCINATION SITE PRURITUS (Slightly itchy at injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash 0.5-2 inches in diameter). On 17-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Solid red at injection site), VACCINATION SITE SWELLING (Slightly swollen at injection site) and VACCINATION SITE PRURITUS (Slightly itchy at injection site). At the time of the report, VACCINATION SITE RASH (Rash 0.5-2 inches in diameter), VACCINATION SITE ERYTHEMA (Solid red at injection site), VACCINATION SITE SWELLING (Slightly swollen at injection site) and VACCINATION SITE PRURITUS (Slightly itchy at injection site) 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 medication included hydrocortisone. No concomitant medications were provided by reporter.
Telephone call to Mom 12/3/03. 12/2: felt cold at 7:30 PM. At 9:30 PM felt hot/cold, dizzy, nauseated, lethargic. 12/3: at 2:45 AM woke up, right arm very sore, shallow rapid breathing, collapsed. At 3 AM Mom took to the ER.
January 20,2022 I woke up with chapped lips which is rare. I had a fever of 102. I took a COVID-19 test and it was positive. I had no other symptoms. The fever was gone by the next day. A week later I began having shortness of breath, broke out with a rash, I was very tired and fatigued. The rash went away a few weeks ago and I have  bruises everywhere the rash was. I still get tired off and on. The doctor did bloodwork and all was good, so she told me I was having side effects of COVID-19.
Rash on arm, neck and torso for both 1st and 2nd dose vaccine
Wrong route,  Should be intramuscular.  Red, warm, pain and itching at injection site.
Patient reports up to a half-dollar size area of skin at injection site that was swollen, red, itchy and radiated heat.    Over the next few days the swollen area traveled from outside her arm into the inside of her arm.  A couple days later the area dissipated.  She also experienced flu-like symptoms including headache, body ache, shivering and a slight fever.
Information has been received from a medical technologist concerning a 26 year old female with an allergy to CEFTIN who on 15-AUG-2007 was vaccinated intramuscularly with a 0.5 ml dose of Gardasil (lot 657872/0515U).  The patient was concomitantly administered DEPO-PROVERA on 15-AUG-2007.  During the evening of 15-AUG-2007, the patient developed a rash all over her body with itching.  The patient contacted the office and was advised by the physician to take two BENADRYL.  The patient recovered on the morning of 16-AUG-2007.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 9/17/2007. The patient had no difficulty breathing or swallowing. Additional information has been requested.
sudden onset fever, chills, all over achiness, nausea, and inability to stand without dizziness. Extreme fatigue. - I had no symptoms from initial 2 of the series.
Information has been received from a registered nurse concerning a patient who on approximately 28-JAN-2008 and 17-MAR-2008 was vaccinated PO with the first and second (lot# 658386/1734U) 2.0 ml doses of Rotateq at 19 weeks of age and at 27 weeks of age.  No adverse event was noted.  The patient sought medical attention in the physician's office.  There was no product quality complaint.  Additional information has been requested.
104 F TEMP FOR 24 HOURS. WAS SENT OUT TO HOSPITAL WITH HIGH TEMP AND CHILLS. WAS REPORTED BY LN THAT FEVER STARTED WITHIN 10 MINUTES OF RESIDENT RECIEVING HIS BOOSTER VACCINE. (#3)
Patient complained of nausea; proceeded to vomit. Reported itching all over, no visible rash noted but flushed on face and neck with no shortness of breath noted.
This patient has an extreme rash within one week. (Ob/Gyn Prescribed Lidex). She had joint pain, started in her fingers, and feet within 2 weeks. Thereafter diagnosed with "seronegative inflammatory arthritis" in the active stage. Currently on Methotrexate, Celebrex, and Arava.
Redness at injection site, itching, pain, edema which increased through out day. Benadryl given by parent and ice applied to area.
pt recvd vax & exp extreme itching w/in 24hrs of vax; pt also exp soreness @ inj site, h/a, & pain in upper rt side;pain in side was noted to poss be d/t baseball game;18JUN95 devel fever 101;
Breakthrough Covid -  symptomatic for 2 weeks; brain fog and feeling not 100% for 6 weeks
Received Pfizer Bivalen 12+ rather than Pfizer Bivalent 6-11yr
Slight rash, 50mg diphenhydramine and monitored for 15 additional minutes after diphenhydramine.
Pain in the breast on the same side where she received the vaccine; She has a breast lump; This spontaneous case was reported by a physician assistant and describes the occurrence of BREAST PAIN (Pain in the breast on the same side where she received the vaccine) and BREAST MASS (She has a breast lump) in a 53-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Patient had no allergies reported. It was Unknown if the patient ever had COVID + test or diagnosis. It was Unknown if patient had received any other vaccines within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Chronic disease (Chronic medical problem, nothing had change after vaccination).    On 28-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 28-Sep-2022, the patient experienced BREAST PAIN (Pain in the breast on the same side where she received the vaccine) and BREAST MASS (She has a breast lump). At the time of the report, BREAST PAIN (Pain in the breast on the same side where she received the vaccine) and BREAST MASS (She has a breast lump) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient takes 10 different regular medications (unspecified).  On an unknown date, the patient received first, second and booster dose of Moderna COVID-19 vaccine (route of administration was unknown).  The patient received the Moderna Bivalent Booster and started experiencing pain in the breast on the same side were she received the vaccine and had a breast lump.  Adverse event caused patient to seek medical care. HCP wanted to perform a Mammogram. It was unknown if the patient experienced a similar event in the past. The symptoms started the same day and they are still ongoing. Patient did nor receive any treatment.
This spontaneous report as received from a physician via a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 29-JUN-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB "10Pk 10mcg/1mL SD LLok Cap AD", lot # L001441 with expiration date 17-AUG-2016 (route of administration and anatomical location were not reported). There were no concomitant therapies and adverse effects reported. No product quality complain was involved. On an unspecified date, the RECOMBIVAX HB had three temperature excursion of 32 F (0 Celsius Degrees) for 40 hours, 33 F (0.5 Celsius Degrees) for 40 hours and 34 F (1.1 Celsius Degrees) for 88 hours, respectively. The vaccine status was reported as "in excursion". The vaccine storage criteria and type of excursion were reported as "Refrigerator (R)". This is one of several cases from the same reporter. Additional information has been requested.
Information has been received from a licensed practical nurse concerning a 19 month old premature white female twin who on 3/26/03, was vaccinated SC in the left thigh with the first dose of varicella virus vaccine live (lot # 643593/0868M). Illness at the time of vaccination included allergic rhinitis and mild recurrent otitis media. The LPN reported that on 9/10/03, the patient developed a rash on her left arm that spread to her hands, feet, mouth, lips and diaper area. The patient was noted to have had more than 50 lesions total. At that time, it was also noted that the patient was exposed to chicken pox two weeks prior. On 9/11/03, the patient also developed a fever. On 9/12/03, the patient was seen by a physician, but no treatment was required. At that time, a diagnosis of herpetic simplex type I rash was made. On 9/17/03, the patient's mother contacted the physician indicating that her daughter had more lesions totaling a little less than 100. On 9/28/03, the patient recovered. Additional information is not expected.
Information has been received from a healthcare worker concerning a patient of unknown age and gender. No concurrent or historical conditions were reported. The reporter stated that the patient was inadvertently vaccinated with the third dose of GARDASIL (dose, frequency, route, lot # and expiration date were not reported) only 11 weeks after the second dose on unspecified dates. Concomitant therapies were not reported. No adverse effect was reported. Additional information has been requested.
blood clots from the knee to top of her leg.; feeling uncomfortable; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (blood clots from the knee to top of her leg.) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypercholesterolemia. Concurrent medical conditions included Diabetes and Hypertension.   On 30-Mar-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced THROMBOSIS (blood clots from the knee to top of her leg.) (seriousness criterion medically significant) and MALAISE (feeling uncomfortable). At the time of the report, THROMBOSIS (blood clots from the knee to top of her leg.) and MALAISE (feeling uncomfortable) outcome was unknown.            Very limited information regarding this event/s has been provided at this time.  Further information is not expected.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information is not expected.
Pain in Deltoid muscles since shot & still to this day Limited range of motion Pain & soreness in arm Required outpatient Physical Therapy Still under P.T. care
Patient given 0.5 mL of Moderna when they should have received the booster dose of 0.25 mL of Moderna.
small reaction; This is a spontaneous report from a contactable HCP . This HCP reported for a 67-years-old female patient that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. Patient's medical history included age related osteoporosis. Type of historical vaccine was reported as vaccination adverse reaction (unspecified). Concomitant medications included abaloparatide (TYMLOS) via a subcutaneous route from 10Aug2019 to ongoing at 80 mcg 1x/day for Age related osteoporosis without therapy. It was reported that the patient took the covid vaccine and had small reaction. Case description: This potential case reported by pharmacy from a consumer is considered invalid with the initial information provided. the case report is missing one or more of the following ICSR minimum elements as defined by the regulations: Adverse event. The outcome of event was unknown.   Information on the lot/batch number has been requested.
Patient was 15w0d G1P0 presented to Emergency Room on 6/28/21 with complaint of mid abdominal pain and low back pain for several hours. Noted some vaginal spotting which occurred the night prior to ER and continued. Ultrasound performed.  Confirmed Spontaneous abortion.  blood type of B-, patient received dose of RhoGam.  Labs: evaluated and unremarkable except for low potassium (3.0) Removal of products of conception at ER.
Patient is a 92 years Old male patient of, DO with history of COPD on chronic 3L NC O2 at home, CAD status post CABG, Alzheimer's dementia, and anxiety disorder, who presented to local General Hospital with weakness, and fall. Pt found to be COVID positive and noted worsen hypoxia.  Dementia and possible acute encephalopathy has complicated care as pt tends to remove O2 and requires higher amount to recover.    Goals of Care Called wife to discuss course and worsened hypoxia She states that she wants him to be comfortable and that we should do whatever we think is right Code status confirmed as DNRCC-A, DNI Discussed getting Palliative care involved, particularly if his hypoxia worsens, and she is in agreement Palliative care consulted, appreciate assistance Family met with palliative on 3/2 and decided on hospice care Patient code status changed to DNRCC   Acute on chronic hypoxic respiratory failure due to  COVID 19 infection Acute COPD exacerbation Patient presentation with generalized weakness and fall, on admit COVID-positive test. Patient is Vaccinated. Pt wears 2-3L O2 at home, Pt at night has been using BIPAP, but removes mask and becomes more hypoxic, so he requires more oxygen in the AM requirement continuing to vary between HFNC and BiPAP, a lot of times triggered by him not keeping oxygen on resulting in worsening hypoxia and longer time to improve Inflammatory markers, improving CT pulmonary arteries no evidence of pulmonary embolism, there is mild to moderate underlying emphysema Completed Decadron (2/20) and completed remdesivir (2/17) by pulmonary Pulmonary input appreciated, cont wean O2 as able Patient has f/u with Dr. on 4/4/2023 at 1 PM Remains intermittently between bipap and 15L oxymizer Appears to be on chronic steroids, which were not resumed after decadron was completed. Chronic steroid dose resumed No improvement in condition, plan to transition to inpatient hospice  Acute on chronic metabolic encephalopathy  in setting of COVID-19 Baseline Alzheimer's dementia Anxiety disorder Pt with delirium on admission, now just not oriented but calm and making jokes. .  Most probably multifactorial from infection and hypoxia and steroids. Continue home medication memantine, and donepezil. Started on Depakote 2/14/23 with good response . Continue home Lexapro.  AKI- resolved.  Most likely due to hydration, COVID infection.  On admission creatinine 1.31, now down to normal Avoid nephrotoxic medications, contrast, NSAIDs, renally dose medication.  Elevated troponin Probable new onset CHF. H/O CAD s/p CABG Severe pulmonary hypertension Elevated proBNP  4195. No chest pain, no new ischemic changes reported.   Likely due to COVID infection.   Echocardiogram EF 55%, hypokinesis of septum grade 2 DD, mod to severe TR, pulm HTN at 85mmHg On lasix 20mg PO
Pt presented to pharmacy 1 day after vaccine administration, reporting severe pain in arm where 2 vaccines were administered. Pt had tried using ice and heat, as well as ibuprofen. Recommended to try TYLENOL and consult provider if no improvement in a few days.
This is a spontaneous report from a non-contactable consumer reporting on herself. A female patient of unspecified age and ethnicity received on an unspecified date PRENVAR13, via an unspecified route of administration in the arm, at single dose. Relevant medical history ad concomitant medications were not reported. On an unspecified date arm and hand were very swollen right below lymph node. The patient mentioned that she tried to sleep and was waking. She further stopped breathing while sleeping that all she was going around. Outcome of the reported events was unknown at the time of this report. No follow-up attempts possible. No further information expected.
Pt. states that after receiving the 1st dose of Influenza High-Dose 10/12/2021, started experiencing symptoms 10/15/2021 of itchiness towards the back of the left arm, crescent shaped with a rash weeping clear fluid, and has since scabbed over. Slight soreness (3 days) has subsided, still continuing to have mild itchiness at the back side of the left arm. No Primary visit noted.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021 at 1:48 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Mar-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 44.99  Concomitant products were not provided.  On 03-Mar-2021, Excursion time was 09AM,10AM,1PM temperature was 51, 34,35 total doses given for the day was 200, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 03-Mar-2021. 20 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021.  On 03-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: Not provided, 9 AM:51, 10 AM: 34, 11 AM: 44, 12 AM:46, 1PM: 35, 2 PM: 36, 3 PM: 36, 4 PM: 36 and 5 PM: Not provided.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Itching, swelling, fever, rash - treated with Benadryl but didn't completely alleviate. Still has symptoms several days later.
No adverse event; The patient was administered an improperly stored dose of M-M-R II; This spontaneous report was received from the Immunization official who was also a nurse concerning a 4-year-old patient of unknown gender. Information regarding the patient's pertinent medical history, concomitant medications or drug reactions/allergies was not provided.  On 11-NOV-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), lot number S004118, expiration date 11-FEB-2021 for prophylaxis (dosage schedule, anatomical location and route of administration were not reported) (product storage error). The vaccine was reconstituted with sterile diluent (lot number and expiration date were not reported).  The administered dose of the vaccine experienced a temperature excursion above 9°C: 10.9 C for 8 hours and 15 minutes, as recorded by a data logger. There was no adverse effect reported.
1-20-20: (Lt) deltoid achy./ 1-21-20: not feeling good; pain and swelling at injection site, also hot to touch. 1-22-20: Feeling worse - Developed Fever and body aches - URI symptoms worse. 1-23-20: vomiting, diarrhea and fever. 1-24-20 - No more vomiting, diarrhea or fever. Feeling a little better and was seen by Dr
The 16 year old person received a .25ml Moderna booster; her primary doses were Pfizer. She sat afterwards for 15min. without any adverse reactions. Was not able to contact person prior to this report submission; left message and will try again later.
Patient called pharmacy on 5/8/23 stating she fills "itchy" all over. Unknown when it started, but that it was after her vaccine and has been getting worse
Patient contacted the pharmacy and let us know that he got a huge (size of an egg) knot on his right under arm, where the shot was given. Patient did no notice the knot until 12/03/17. He got the shot on 12/01/17. Patient did mention that he does not have any other problem beside the swelling on the area of the shot. The pharmacist on duty had mention the patient to put some ice pack over it and if any thing  else occur, he will need to go to the doctor.
Large increase in menstruation cycles to high flow and migraines, migraines have no reaction to tylenol.  This is completely unusual to regular cycles.
swollen node, extreme pain in my left armpit, some pressure in my chest as a result of the pain in armpit area
pt states recv vax 9MAY96 & 10MAY96 woke w/a couple chancre like sore inside lower lip & on tongue;says sores cont to appear each cay;covering inside lower lips & sides of tongue
had to get steroid shot on the knee for a pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (had to get steroid shot on the knee for a pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported.).    On 03-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ARTHRALGIA (had to get steroid shot on the knee for a pain). At the time of the report, ARTHRALGIA (had to get steroid shot on the knee for a pain) outcome was unknown.            Reporter did not allow further contact