chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Info has been received from an RN concerning a 27 month old white female with no allergies or medical history who on 12/12/03 was vaccinated, SC, with a 1st dose of MMRII. There was no illness at the time of vaccination. On 4/7/05, the pt developed a rash with spots on her back that were itchy. She was noted to be cranky but afebrile. The rash started on her right arm and scabbed over. It spread to her face and back. It was also noted that she had the fifths disease. The pt was seen in the physician's office. Subsequently,. the pt recovered. No further info is expected.
A 31 y.o. male with no significant past medical history who presented to RMH 4/1/2023 with complaints of right lower extremity pain.  Patient went to urgent care 3/31/2023 and was given antibiotics and steroids for arthritis.  Admitted for concerns of ischemic limb   1. Right LE vasculopathy: Presented with swelling, skin discoloration. Pulses, sensation Intact.  Duplex negative.  Right ABI abnormal.  CTA abdominal aorta with lower extremity runoff 4/1/2023 with no evidence of RLE large vessel arterial occlusion, likely small vessel occlusion , COVID vasculitis per vascular medicine. C3, C4, Hepatitis panel, ANA, ANCA mixing studies normal. Cryoglobulins pending.  Continued heparin drip- changed to eliquis 4/6/2023. Peripheral vascular cardiology advised norvasc, pletal and consideration for formal angio 4/4/23. TTE 4/2/23 with NLVEF, no vegetations. R foot MRI 4/3/23 neg for abscess, blood cultures 4/2/23 negative to date. RLE angio 4/4/23 with evidence of diffuse inflammation of the right foot as evidenced by vasodilation induced rapid flow and occlusion of digital vessels of R toe- likely related to COVID induced coagulopathy/vasculopathy. Hyperbaric Rx started 4/5/2023. To discharge on plavix, eliquis, pletal and norvasc. ID started vancomycin 4/2/23- stopped 4/5/23. Continued supportive care with IV/PO narcs. Pain team followed for optimal pain control. 2. COVID-19: Reportedly diagnosed 3/28/2023 with home test.  Had symptoms of malaise, cough, roughly a week before that.  Vaccinated and boosted.  + 4/1/2023.  No respiratory distress.  Not a candidate for remdesivir/steroids . Vascular complications as above. 3. Leukocytosis: Likely reactive due to steroid use as given by urgent care .  Afebrile.  Trended. 4. Marijuana dependence: Daily use.  Cessation advised 5. Alcohol dependence: Reports that he drinks only on weekends but drinks "a lot" reports no signs of withdrawal. 6. Nicotine dependence: Uses e-cigarettes.  Refused patch.  Cessation advised.
Numbness & tingling extending from right jaw down cheek and jaw to chin and upper and lower lips
Systemic: Abdominal Pain-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Severe, Systemic: Seizure-Severe, Systemic: Shakiness-Severe, Systemic: Vomiting-Severe, Additional Details: Injection was given, patient seemed allright, then patient started to seize/shake. She was unresponsive for about 60-90 seconds then she stopped shaking and was aware of her surroundings, felt sick and vomited. She was given water and crackers after a couple minutes. Rescue squad was called as soon as patient started shaking/seizing. They came, checked her vitals, parents did not feel needed ambulance/hospital. Patient left alert,on her own accord.Reached out to parent later in the day no answer
Muscle and joint aches starting approximately 9:15 AM 04/08, dizziness and syncope at appx 10:00 AM, followed by nausea. I was transported via ambulance to  given Zofran and started on LR IV en route.   At Suburban I was next placed on normal saline IV and given Tylenol. I was feeling pain in my back left hip and on the back left side of my head so I had hip and chest x-rays and a head CT done. All imaging and labs were normal and I was feeling well enough to be discharged at appx 2:30 PM.   Following the visit to the ER I continued to feel muscle and joint aches, but no longer any dizziness or nausea. I also started having a headache. I continue to have a headache through today, 04/09. I followed up with my primary care provider this afternoon who said it was possibly a lingering concussion from hitting my head during syncope episode.
HAD VAC ON 6-26-90.  ON 7-6-90, TEMP 105.5, HAD SZ X 10 MINUTES.  ADMITTED TO HOSP. LP ABNORM (NEUTROPHILS IN CSF) CULTURE NEGATIVE.  CHILD FINE
rash on her back; rash on lesft side of injection arm; rash on her breast; shingles; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on her back), VACCINATION SITE RASH (rash on lesft side of injection arm), RASH (rash on her breast) and HERPES ZOSTER (shingles) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (Controlled high blood pressure). Concomitant products included TAMOXIFEN for Breast cancer, LOSARTAN POTASSIUM (COZAAR) for Hypertension.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced RASH (rash on her back), VACCINATION SITE RASH (rash on lesft side of injection arm), RASH (rash on her breast) and HERPES ZOSTER (shingles). On 10-Mar-2021, HERPES ZOSTER (shingles) had resolved. At the time of the report, RASH (rash on her back), VACCINATION SITE RASH (rash on lesft side of injection arm) and RASH (rash on her breast) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Mar-2021: Date of Birth of patient, first and second dose details, events after second dose were added On 29-Apr-2021: Patient's details such as height, weight, race and ethnicity, medical history, concomitant medications, outcome of event (shingles) changed
Adrenaline rush or rapid heart rate sensation (immediate).  Stomach upset (within 1/2 hour).  Excessive/sudden sneezing (within 1/2 hour, lasting a day or two). Itchy/watery eyes (within 1/2 hour to an hour). Mental/emotional changes within hours (irrational fear).
Got Covid in early Apr2023; Got Covid in early Apr2023; Interchange of vaccine products; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Jul2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 42 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Feb2021 as dose 1, single (Batch/Lot number: unknown), in Mar2021 as dose 2, single (Batch/Lot number: unknown) and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "endometriosis" (unspecified if ongoing); "severe varicose veins with treatment" (unspecified if ongoing); "history of bell's palsy" (unspecified if ongoing); "Allergy" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Jul2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "Got Covid in early Apr2023". The event "got covid in early apr2023" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. It was unknown if therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical course: Patient had no prolonged hospitalization. It was unknown that patient received any other vaccines within 4 weeks prior to the COVID vaccine. There were other medications the patient received within 2 weeks of vaccination. Seeking medical care by primary physician. Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient had any known allergies.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300211339 same patient and drug, different event;
Localized reaction, raised, itchy, tender, erythematous, round mass surrounding injection site. 5cm x 5cm.
This spontaneous report was received from a consumer refers to herself as a 57 year old female patient. The patient current conditions included with glaucoma. The patient was allergic to sulfa drug. On 12-SEP-2015, the patient was vaccinated with ZOSTAVAX (dose, route and lot# were not reported). Concomitant therapies included unspecified doses of TRAVATAN and MICROGESTIN as well as received an unspecified flu vaccine and pneumonia vaccine in the other arm in the next few days approximately in 2015 after receiving the ZOSTAVAX. The patient stated that after receiving the ZOSTAVAX approximately on 12-SEP-2015, she had a severe reaction in her left arm where the vaccine was received. Immediately after receiving the ZOSTAVAX approximately on 12-SEP-2015, there were bumps and itching around the injection area. Within 48 hours approximately on 14-SEP-2015, these reactions went away. Then within one week of receiving the ZOSTAVAX approximately in September 2015, bumps of the same size and the accompanying itching that had surrounded the injection site appeared on the outer left arm from the wrist bone up about 5 inches toward the elbow. On an unknown date approximately in 2015, these bumps got warm, painful, and had severe itch that want to claw at although the desire to itch gone away in approximately 10 seconds. On an unknown date approximately in 2015, the bumps appeared red just under the skin that is probably blood vessel breakage but do not actually bleed. The patient was now in day 30 of the reaction. It was diminished, but still evident. Patient did not sought medical attention. The patient was self-treated with unspecified doses of BENADRYL and SOVERIGN SILVER GEL plus 10% cortisone cream to calm the itching. The outcome of events bumps of the same size and the accompanying itching that had surrounded the injection site appeared on the outer left arm from the wrist bone up about 5 inches toward the elbow, bumps got warm, painful, had severe itch and bumps appeared red was recovering/resolving. The reporter did not provide the causality between the event and the suspect therapy. Additional information is not expected as the reporter did not wish further contact.
is in a lot pain going down the right side in to his crotch and legs and screams out in pain. Pain is getting worse; he has lost some weight; He is having trouble with his memory; is in a lot pain going down the right side in to his crotch and legs and screams out in pain. Pain is getting worse/He has pain down his right side into his crotch and down his leg; This is a spontaneous report from a contactable consumer (wife). An 80-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, batch/lot number: 2L3247) intramuscularly into the right arm on 20Jan2021 15:00 (at the age of 80-year-old) as single dose for COVID-19 immunisation. The patient's medical history included diabetic, COPD, prostrate cancer. He has a hard time breathing and was on oxygen. Concomitant medications were not reported. The patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, batch/lot number: EN5318) intramuscularly into the right arm on 17Feb2021 10:30 AM as single dose for COVID-19 immunisation. On an unspecified date, the reporter stated that her husband had the first dose of the Pfizer covid 19 vaccine on 20Jan2021 and was in a lot pain going down the right side into his crotch and legs and screams out in pain. Pain was getting worse and wanted to know if this was a side effect of the vaccine. He was not getting the second dose of the Pfizer covid 19 vaccine because of the adverse event he experienced with the first dose. He was on oxygen and had to carry an oxygen tank. He was due to get the second shot on Wednesday. She wanted to check and make sure. It may be a muscle thing. It seems to be getting worse and worse. He can hardly get up. He cannot hardly sleep in the bed. He does not want to get the next shot and his left side be in pain. Then he would not be able to do anything. He had lost some weight around 230 pounds. He has the first stages of Alzheimer's and clarified that has not been diagnosed yet with Alzheimer's. He had a test a couple years ago and it was normal. He was having trouble with his memory. He got the flu shot on 01Sep2020. He takes two cases full of medication. He was diabetic. He took shots in his stomach. It was changed over. No further details provided. Pain on right side started two days later. She does not know, but was assuming it was the muscle, going to be a little sore. It had progressively worsened. He could hardly move to go to the bathroom. He had prostate cancer a few years ago and has to wear underpants. He cannot bend over to put on his underpants or socks. He screams in pain. He does not do well with pain. No prior vaccinations within 4 weeks. Relevant tests included X-Ray on 26Feb2021 with unknown results. Outcome was unknown for all the events.  Follow-up attempts are completed. No further information was expected.
CELLULITIS, BUTTOCKS AT INJECTION SITE, ABX THERAPY STARTED ON ADMISSIN 8/23/09 9/30/09 MR received for DOS 8/23-26/09 with d/C DX: Left Buttock Cellulitis 2' to pneumococcal vaccine.  Pt presented with to ER with fever and injection site pain.  10x12 cm erythema, induration and tenderness noted at injection site.  Admitted for IV abx with good results.
patient called complaining of groin pain stating it started about an hour after injection, next day pharmacist called and patient said it was improving but still swollen and a little tender
Staff notices patient was breathing deeply and slowly.  Asked patient if he is feeling unwell.  Patient states he feels lightheaded.  Patient then became diaphoretic.  Took patient to medical tent via wheelchair.  Vital signs stable.  Gave patient orange juice and water and applied a cold damp towel.  Patient stopped sweating and states he no longer feels dizzy.  Too BP sitting and standing.  Stable both ways. Symptoms noted: paleness, sweating, fainting, lightheadedness,; Orientation x 3.  Vital Signs:  12:47pm  - bp 116/62, p 71, r 15, pulse ox 98;  Vital signs:  12:53pm - bp 120/76, p 74, r 16, pulse ox 98; patient treated at vaccine location, stabilized and discharged to home, alert and oriented with no further complaints.
2x2 1/2 raised erythemic blistering lesion increasing in size over (R) upper thigh pruritic with generalized developing pruritis all over body.
pt went limp (for 10 mins) @ 1030PM & turned sheet white for 45 mins; taken to ER; dx ear infect;
PATIENT EXPERIENCES HIGH FEVER AFTER GETTING THE VACCINES ON THE SAME DAY. ACCORDING TO THE NURSE FROM FAMILY RESIDENCE AND ESSENTIAL ENTERPRISE, PATIENT ALREADY GOT A FLU SHOT WITH HIS PRIMARY CARE PHYSICIAN ON 09/11/2018.
Patient felt dizzy and almost fainted within 5 minutes after receiving 2nd Moderna vaccine.  Pt was seated in post-vaccination area but did not faint.  Cold compress applied to patient neck, BP taken every 10 minutes and Patient flexed muscles to increase blood flow.  Pt was felt well after 25 minutes.  Pt got up and walked out of building with no assistance after 30 minutes after shot.
This spontaneous initial report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. The reporter informed that on an unspecified date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N008077, with expiration date 09-MAR-2019 (strength, dose, frequency, route of administration were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (MRK). No adverse effect was reported. The temperature of excursion was reported as 20.5 degree Fahrenheit (°F). The time frame was reported as 2 hours. There was no previous temperature of excursion was not reported. There was a digital data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1711USA002444: US-009507513-1711USA002760: US-009507513-1711USA002761.
Sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine. Concurrent medical conditions included neurological disorder nos, back disorder and allergy.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient had been receiving allergy and serum shots as he was allergic to 49 different things. He also had the original Shingles shot in the past.  The patient received the first dose of Shingrix vaccine about 3 months ago in the left arm.  The patient experienced a sore arm with it. He did not remember how long it lasted but he recovered from the sore arm. The reporter had consented to follow up. No further details were provided. This case has been linked with the case US2019AMR115561, reported by same reporter for same patient.
redness in the area to the side of the injection site; swelling in the area to the side of the injection site; itchy/itchy in the area to the side of the injection site; arm was sore; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (arm was sore), VACCINATION SITE PAIN (itchy/itchy in the area to the side of the injection site), VACCINATION SITE ERYTHEMA (redness in the area to the side of the injection site) and INJECTION SITE SWELLING (swelling in the area to the side of the injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A.) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm was sore). On 18-Jan-2021, the patient experienced VACCINATION SITE PAIN (itchy/itchy in the area to the side of the injection site). On 20-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness in the area to the side of the injection site) and INJECTION SITE SWELLING (swelling in the area to the side of the injection site). On 16-Jan-2021, PAIN IN EXTREMITY (arm was sore) outcome was unknown. At the time of the report, VACCINATION SITE PAIN (itchy/itchy in the area to the side of the injection site), VACCINATION SITE ERYTHEMA (redness in the area to the side of the injection site) and INJECTION SITE SWELLING (swelling in the area to the side of the 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.   No relevant concomitant mediation was reported.  Treatment information was not provided.
Patients have been administered Moderna vaccine while temperature excursion assessment has been ongoing; Patients have been administered Moderna vaccine while temperature excursion assessment has been ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered Moderna vaccine while temperature excursion assessment has been ongoing) and EXPIRED PRODUCT ADMINISTERED (Patients have been administered Moderna vaccine while temperature excursion assessment has been ongoing) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered Moderna vaccine while temperature excursion assessment has been ongoing) and EXPIRED PRODUCT ADMINISTERED (Patients have been administered Moderna vaccine while temperature excursion assessment has been ongoing). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered Moderna vaccine while temperature excursion assessment has been ongoing) and EXPIRED PRODUCT ADMINISTERED (Patients have been administered Moderna vaccine while temperature excursion assessment has been ongoing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because the facility was unable to download the digital data logger, would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at this time. No adverse reactions were reported by any patients.   This case was linked to MOD-2022-501575 (Patient Link).
Fever, chills, nausea, diarrhea, pain at injection site, fatigue.
neuropathy in left hand (pinky and ring finger)/Neuropathy consists of numbness and parasthesias; This is a spontaneous report from a contactable pharmacist (patient). A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 66-year-old, via an unspecified route of administration, administered in left arm (reported also as left shoulder) on 08Mar2021 12:45 (Lot Number: EN6199) as single dose for COVID-19 immunisation. There were no medical history and concomitant medications. On 11Mar2021 (reported as 3 days after the vaccination), the patient experienced neuropathy in left hand (pinky and ring finger) which consists of numbness and parasthesias. The patient took aspirin with no effect. As of 11Mar2021, the event was not recovered.; Sender's Comments: The information is limited and does not allow a full medical assessment. Considering temporal relationship, a possible contribution role of vaccination with BNT162B2 to the onset of neuropathy, cannot be excluded. The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Dizziness, nausea, couldn't keep fluids down. Subsided after 3 hours with rest.
Janssen COVID-19 Vaccine EUA Chills and fever of 103.1 degrees F, elevated heart rate (average 91 bpm) during the night of 3/6/21; Sneezing, runny nose. Treated with Ibuprofen and symptoms resolved  by morning of 3/7/21.
Immunization site swollen and red size 1/2 dollar, developed cellulitis, size 7cm X 5cm. Went to ER on 4/20/00.