chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient with a large local area of redness and swelling.  3 x 7 cm anterior upper right thigh.  Patient was fatigue and achy with low grade fever 1 day prior.  At 48 hours, less redness, but swelling significant with area hot to touch.
Information has been received from a female pt who in 4/00 was vaccinated with the 1st dose of Hep-B vaccine, 6 weeks after giving birth. That same week, the pt started having hot flashes and experienced flushing, with a feeling of warmth radiating from the injection site down her arm. The pt sought medical attention. No further information is available.
Patient with previous adverse reaction to vaccinations was taken to get "caught up" in order to attend school the following week.   Patient complained of stomach ache, chest pain, headache and intermittent loss of vision on the drive home. Reports father didn't believe him, and father reports no fever, or other symptoms. Transferred to mother three days later, and patient reported symptoms were repeating. Complained again of headache, and was alseep within moments of the comment. A couple hours later, patient woke up crying, and was unresponsive to queries about what was happening. All touch was overstimulating, and limbs jerked erratically. Patient was hyperventilating and continued to be unresponsive to questions. Mother held patient to calm him and he fell asleep for a moment, then began crying and flailing again. This went on for at least twenty to thirty minutes and patient began to scratch at his body, particularly his feet. Mother touched his foot and felt a steady shocking sensation. Mother took to doctor, who gave detox protocol.  Over a week later, patient is still experiencing pain at the injection sites and having unusual sleeping patterns.
Following vaccination, patient experienced lightheadedness, dizziness, headache and nausea. BP elevated. Blood sugar 315. Little improvement following rest in reclining position. Transferred to the hospital via ambulance. Next day, family reported patient was released from the hospital that evening and has resumed activity . No rash or wheezing noted during the episode.  Telephone call to patient x2 for more information to complete VAERS but did not return my calls.
Mom states there was swelling noted from shoulder to elbow. Notes of redness and warmth to the area. Patient was given TYLENOL/ibuprofen for swelling, temperature elevation (101)-OTC. Mom denied shortness of breath, pain but confirmed itching and discomfort to the injection site.
Fever, weakness; swelling Rt. UE. Cellulitis RUE. Tx - Vancomycin 1gm IV Q12 hours; ZOSYN 3.375gm IV Q6 hours.
Pt diagnosed with nunnular eczema post 2nd or 3rd anthrax shot (3 weeks post). Eczema not responsive to conventional treatment.
Cold symptoms; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold symptoms) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included Immunodeficiency NOS.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced NASOPHARYNGITIS (Cold symptoms). The patient was treated with PREDNISONE for Immunodeficiency, at an unspecified dose and frequency and AMOXICILLIN, CLAVULANATE POTASSIUM (AUGMENTINE SR) at an unspecified dose and frequency. On 11-Jan-2021, NASOPHARYNGITIS (Cold symptoms) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided; Sender's Comments: Based on the start date of the event (prior administration of mRNA-1273) the event is assessed as unlikely related to mRNA-1273.
Fever; Chills; Muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Muscle ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Muscle ache). At the time of the report, PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Muscle ache) outcome was unknown.            Treatment details not provided
I had an intestinal flu, a lot of diarrheas and this occurred on February 5th. I had a temperature/fever of 100.8. I also had a lot of stomach nausea & diarrhea.
developed shingles in the weeks following his first dose /diagnosed with herpes zoster; development of a blistering rash on the left forearm; This case was reported by a other health professional via sales rep and described the occurrence of shingles in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included meloxicam unknown for product used for unknown indication.   On 6th June 2018, the patient received the 1st dose of Shingrix .5 ml. In June 2018, the patient started meloxicam at an unknown dose and frequency. In June 2018, less than 3 weeks after receiving Shingrix, the patient experienced shingles and blistery rash. The action taken with meloxicam was unknown. On an unknown date, the outcome of the shingles and blistery rash were unknown.   It was unknown if the reporter considered the shingles and blistery rash to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose and developed blistering rash on the left forearm and visited the clinic on 24th June 2018 The patient then diagnosed with herpes zoster at an urgent care and patient believed it was due to the vaccine. Patient also stated that he had just started meloxicam one week prior to the event and believed that contributed to the shingles. The patient was due for the 2nd dose of Shingrix on 6th December 2018. It was unknown if the reporter considered the shingles and blistery rash to be related to meloxicam .
received her first covid-19 vaccine on 18Feb2021, a week later on Feb2021 she tested positive for covid-19; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 18Feb2021, at a single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her first covid-19 vaccine on 18Feb2021, a week later on Feb2021 she tested positive for covid-19. She was inquiring if she should receive the second dose. The outcome of the event was unknown.  Information about the lot/batch number has been requested.
5 days after the 2nd vaccine, patient developed rash on his abdomen which spread around the right side to his flank and additional spots on his left shoulder blade. Itchy, not painful, vesicular
Red ring surrounding the area; Bacterial skin infection; Slight pain for few hours after the vaccination; This spontaneous case was reported by a consumer and describes the occurrence of SKIN BACTERIAL INFECTION (Bacterial skin infection), VACCINATION SITE ERYTHEMA (Red ring surrounding the area) and VACCINATION SITE PAIN (Slight pain for few hours after the vaccination) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 032M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CLOBETASOL for Vaginal irritation, CLONAZEPAM for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE PAIN (Slight pain for few hours after the vaccination). On 22-Feb-2021, the patient experienced SKIN BACTERIAL INFECTION (Bacterial skin infection). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Red ring surrounding the area). The patient was treated with CEFALEXIN (KEFLEX [CEFALEXIN]) on 23-Feb-2021 for Skin infection, at a dose of 500 mg twice a day. On 08-Feb-2021, VACCINATION SITE PAIN (Slight pain for few hours after the vaccination) had resolved. At the time of the report, SKIN BACTERIAL INFECTION (Bacterial skin infection) outcome was unknown and VACCINATION SITE ERYTHEMA (Red ring surrounding the area) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient stated that the doctor said her to take antibiotics for 5 days instead of 7 if she wishes to do so.   This case was linked to MOD-2021-187387 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Added concomitant medication, Added event, added dosage information On 27-May-2021: NNI
a rash that felt like the injection site was on fire; a rash that felt like the injection site was on fire; chills; headache; extreme fatigue; Low grade fever/ fever as high as 103.8; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 14Apr2021 at 15:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included psoriasis and psoriatic arthritis. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included cetirizine hydrochloride (ZYRTEC) and vitamin d nos (MANUFACTURER UNKNOWN), both for an unknown indication from an unknown date and unknown if ongoing. The patient previously took doxycycline (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy. On 14Apr2021 at 18:30, the patient experienced low grade fever within 3 hours of second shot. On 15Apr2021, second day, the patient experienced fever as high as 103.8 (unspecified units), chills, headache and extreme fatigue. On 16Apr2021, third day, experienced low grade fever and a rash that felt like the injection site was on fire. On 15Apr2021, the patient underwent body temperature test and the result was as high as 103.8 (unspecified units). The events resulted in a visit to the emergency room/department or urgent care. Therapeutic measures were taken as a result of reported events and included treatment with Ibuprofen (MANUFACTURER UNKNOWN) and anti-nausea medication (unspecified) and diphenhydramine hydrochloride (BENADRYL) cream. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events low grade fever, fever as high as 103.8, chills ,headache, extreme fatigue, rash that felt like the injection site was on fire was recovering at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Pain in hands and wrist bilateral. Lost the ability to dorsiflex the wrist with fingers extended. All Labs and MRI are normal
Brief Summary/Assessment: 68M PMH myopathy (bed bound, most c/w colchicine-induced myopathy, started 8/2021), HFpEF, HTN, CKD, AF (rivarox), DM, bipolar, gout, OSA (CPAP), sacral ulcer with chronic OM, p/w hypercarbic respiratory failure which resolved with BiPAP. Course c/b Cdiff and nosocomial COVID infection. Patient died
skin changes after Moderna Bivalent vaccine; 4-5 cm area of geographic distribution of multiple brown-colored macule and patch in R deltoid area; It was dry; scaly texture; patient feels warm; patient feels itchy/spreading; This spontaneous case was reported by a physician and describes the occurrence of SKIN DISORDER (skin changes after Moderna Bivalent vaccine), MACULE (4-5 cm area of geographic distribution of multiple brown-colored macule and patch in R deltoid area), DRY SKIN (It was dry), SKIN EXFOLIATION (scaly texture) and SKIN WARM (patient feels warm) in a 58-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 053D22A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SKIN DISORDER (skin changes after Moderna Bivalent vaccine), MACULE (4-5 cm area of geographic distribution of multiple brown-colored macule and patch in R deltoid area), DRY SKIN (It was dry), SKIN EXFOLIATION (scaly texture), SKIN WARM (patient feels warm) and PRURITUS (patient feels itchy/spreading). The patient was treated with BETAMETHASONE, CLOTRIMAZOLE (CLOTRIMAZOLE AND BETAMETHASONE) at an unspecified dose and frequency. At the time of the report, SKIN DISORDER (skin changes after Moderna Bivalent vaccine), MACULE (4-5 cm area of geographic distribution of multiple brown-colored macule and patch in R deltoid area), DRY SKIN (It was dry), SKIN EXFOLIATION (scaly texture), SKIN WARM (patient feels warm) and PRURITUS (patient feels itchy/spreading) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Patient was a healthy with no known allergy or skin issues. HCP stated that he had never seen such reaction before because the vaccine was new. Concomitant medications were not reported.
Initial information received on 13-Mar-2019 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 13 months (also reported as 1 year) old male patient who inadvertently received 4th dose of vaccine IPOL on 13 mar 2019. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. Concomitant medications included HIB VACCINE (HIB); VARICELLA ZOSTER VACCINE (VARICELLA VACCINE); PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE); and HEPATITIS A VACCINE (HEPATITIS A). On 13-Mar-2019, the patient received a 4th dose of suspect 0.5 ml IPV (VERO) (lot number: N1K921M and expiry date: 14-Nov-2019) (route and site of administration was not reported). The patient had received his first 3 doses of IPOL on schedule. It was a case of actual medication error due to inappropriate schedule of vaccine administered as he was inadvertently administered a 4th dose on 13 Mar 2019, which should not have been administered until after the patient's 4th birthday (in 2022). It was unknown if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Information has been received from a registered nurse referring to 2 patients of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 12-NOV-2015, the patients were vaccinated with ZOSTAVAX (0.65 ml, Lot#L024997, expiration date: 06-OCT-2016), which were improperly stored for 50 days (Incorrect product storage). The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Missed second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was provided by the reporter.  No treatment information was provided.
12/6/2021 - presents to ED SOB/chest pain/severe dyspnea. Patient is on dialysis 3xs/wk but missed 1 day. Temp 98.6, HR 108, R 20, BP  215/122, SPO2 92%. D dimer 469. Sepsis/Covid pneumonia and need for urgent dialysis. Covid+ on admit. Patient dialyzed in ED. Following this, RA sat 99%, BP 212/112. Reglan, Tylenol, and Clonidine given - BP improved. Casirivimab/imdevimab given. CXR neg for PE.Prepared for discharge with Covid at home.  12/7- Subsequently presents chest pain/SOB to ED. T-101.5,R-22,HR-149, BP-188/126, O2 94% RA. Admit to ICU acute RF due to Covid. CXR shows groundglass bil pneumonia. Started ceftriaxone, azithromycin, heparin. Decadron continued. Not a candidate for Baricitinib/Remdesivir.
p/vax pt started to have stiffening of upper & lower extremities w/no foaming of the mouth or uprolling of eyeballs & still having them as of today;
This is a spontaneous report from a contactable physician and a contactable nurse via Pfizer sales representative. This physician and nurse reported same events for 6 patients. This is the 6th of 6 reports. An approximately 16-year-old patient of an unspecified ethnicity and gender received the first single dose of TRUMENBA for immunization. Medical history and concomitant drug was unknown. Patient experienced rash/hives following first dose of meningococcal group b rlp2086. Symptoms were moderate and resolved after few days. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017286355 same reporter/product/events, different patient.
The patients arm was swollen not the site of injection but the whole arm was swollen and pt complains that her arm hurts when she tries to lift the arm up straight , there is area where she has some redness on the upper arm but not the injection site.
Tolerated administration of vaccine, but developed full-body hives (urticaria) on 9/8/21 (4 days later). He visited urgent care, where he had allergy testing obtained, which is negative thus far, and negative/normal CBC, BMP, ESR, CRP, and troponin. He was prescribed Zyrtec, prednisone, and an EpiPen PRN and discharged home. Started steroid (1 dose), but had an episode of syncope after getting out of the shower. EMS was called, and they documented BP 80's/50's. He was given IVF and brought to Emergency Department, where he was admitted for observation. Hives resolved, he had normal BP and hemodynamics throughout his stay. EKG showed sinus tachycardia, and ECHO was normal with no sign of effusion, pericarditis or myocarditis.
About 3 minutes after I received the vaccine I became flushed for just a few moments and had a strange taste in my mouth.  I could feel a tingle in my mouth at the same time.  I became panicked of course but the flushing quickly subsided.   The mouth sensation lasted a bit longer but there was no airway compromise at all.
Patient stated she broke out with rash/hives on neck, chest and both arms the day of her 1st vaccine given on March 15, 2021. Patient was seen by the doctor three times after first vaccine was administered. Patient was given medication for the rash/hives but meds were not working. Patient received a second dose on 4/6/21 and the same thing occurred with a rash/hives on both arms, neck and chest. Patient stated she never had a rash/hives before she received the vaccine. Per patient stated she also felt hot like a fever and her lips were "fever chapped".  as of today 4/16/21 the patient still has slight spots of rash/hives on right lower arm and neck area.
Began Menstrual Cycle when it wasn't due.  The second dose of Moderna did the same thing.
The pt experienced a petechial rash which started on 3/17/00, 7 weeks post vax. First platelet count 3/20/00 was 42,000.
I have lymphedema in my right leg and my lymphedema got considerably worse for 2 weeks afterwards; This is a spontaneous report from a contactable Nurse (patient). A 63-years-old female non-pregnant Nurse patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EL9261), dose 1 via an unspecified route of administration, administered in Arm Left on 25Jan2021 at 13:00 (at the age of 64-years-old) as a DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was none. There were no concomitant medications. No known allergies were reported. Other medical history was none. No other vaccine was administered in four weeks. Other medications in two weeks were none. Patient did not have covid prior vaccination and was not tested for covid post vaccination. The patient said, I have lymphedema in my right leg and my lymphedema got considerably worse for 2 weeks afterwards on 25Jan2021 at 16:00. No treatment was received for events. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EL9269), dose 2 via an unspecified route of administration, administered in Arm Left on 23Feb2021 at 13:00 (at the age of 64-years-old) as a DOSE 2, SINGLE for covid-19 immunisation. Outcome of the event was recovering.    Follow-Up (26Aug2021): Follow-up attempts are completed. No further information is expected.
Pt was seen in Family Medicine on 4/23/2021.  Was given her first Moderna vaccine that day.  On-call doctor received phone call on 4/24/2021 that pt had expired.   Death certificate states cause of death: seizure due to possible complication of COVID 19 vaccine. Conditions if any, leading to immediate cause:  cerebellopontine angle tumor of brain