chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Started out as red circle around shot. By third day it had spread to entire upper arm, very swollen, very hot, ached horribly, and it ran into the inside of the arm and down to elbow area.
The patient is stating that his arm is extremely sore. He states that he can barely lift his arm. He states the pharmacist gave the shot too high.
PATIENT REPORTED METALLIC TASTE IN HER MOUTH 15 MINUTES AFTER VACCINE
Patient developed an itchy rash on her neck, chest, and back.  The rash developed while sleeping and she woke up and took Claritin.  The rash persisted in the morning and she took another Claritin without relief.  She reported to the clinic at 11 am, at which time I noted a faint urticarial rash on her back, neck, and chest.  I prescribed Depo-Medrol 80 mg IM and recommended she take Zyrtec 10 mg daily, with instructions to see me if the rash did not improve.
Grand mal seizure. Taken to ED, evaluation including CT, MRI brain, chemistries all normal, o/n EEG negative. Undergoing further neurology evaluation.
Right and left thighs with red, raised areas hot to the touch around injection sites noticed by therapist at approx. 1:35 pm when patient was taken out of his seat to begin therapy.
her kidneys had shut down / kidneys were not functioning; She could barely walk, talk or breathe.; She could barely walk, talk or breathe.; She could barely walk, talk or breathe.; Nauseous; Throat was clogged up, she could not swallow; Her throat was clogged up, she could not swallow and so on but the dialysis helped her get her numbers good; This is a spontaneous report from a contactable consumer (patient's husband). A 76-year-old female patient received bnt162b2 (Pfizer COVID-19 Vaccine - Comirnaty), second single dose via an unspecified route of administration on 15Mar2021 (Batch/Lot Number: EN6208) for covid-19 immunisation at age of 75-year-old. The patient previous received first dose of bnt162b2 for COVID-19 immunization on 20Feb2021 (lot number: EN6200) at age of 75-year-old. Medical history included diabetic. Concomitant drug included taking diabetic medications for diabetic. The patient had no any other vaccination 4 weeks prior to the COVID 19 Vaccine. The patient had a serious event that may have been connected with the Pfizer COVID-19 Vaccine - Comirnaty. Patient received her second dose of the Pfizer COVID-19 Vaccine on 15Mar2021. He stated that to their knowledge she never had COVID-19. 2 weeks prior (Aug2021), her body shut down completely. She could barely walk, talk or breathe. Reporter took her to the emergency room and they ran all kinds of tests, MRI's and everything. They admitted her to ICU and determined from bloodwork that her kidneys had shut down. They put her own dialysis for 3 days and the infectious disease doctors and other doctors had no idea what caused this. They said they wanted to see if she could come off dialysis. So they took her off and her kidneys have been okay. She improved enough to be moved to a rehab facility and she is coming home tomorrow. Patient did not have COVID. Although it's possible that she had asymptomatic COVID (further clarification unknown). Now what happened was two weeks prior, all of a sudden her body shut down over a couple hours, reporter had to take her to the emergency room. She had trouble breathing, she was nauseous. They did not know what was wrong, they put her in critical condition into the ICU. They find out through the bloodwork that the kidneys were not functioning, they had shutdown. They put her on dialysis for three days each day her numbers got better. At the end of the three days, they stopped the dialysis just to see what would happen. They didn't have the clue as to what was wrong, if she could still at that point could really barely talk. Her throat was clogged up, she could not swallow and so on but the dialysis helped her get her numbers good and then over the next couple days everything cleared up and now two weeks later she's in rehab (further clarification unknown), she's coming home tomorrow. She did have some lab tests in Apr2021. Patient was improved after the events, after the treatment, they had improved with kidney dialysis.   Follow-up attempts are completed. No further information is expected.
Diagnosed with COVID-19; This spontaneous case was reported by a paramedic (subsequently medically confirmed) and describes the occurrence of COVID-19 (Diagnosed with COVID-19) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced COVID-19 (Diagnosed with COVID-19). On 11-Jan-2021, COVID-19 (Diagnosed with COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2021, SARS-CoV-2 test positive: positive Positive.     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.   Concomitant medications were not provided  Treatment information was not provided.; Sender's Comments: Based on the fact the vaccine itself does not contain the virus that would be transmitted and capable of causing the COVID-19 infection in the patient receiving the vaccine, the event is assessed as unlikely related to mRNA-1273.
Information has been received from a licensed practicing nurse concerning a 25 year old female who in July 2008, was vaccinated with a first dose of GARDASIL (route and administration site not reported).  On 05-SEP-2008 the patient was vaccinated with a second dose of GARDASIL (route and administration site not reported).  On 07-SEP-2008 the patient developed a pinpoint rash on the neck and chest and a little bit on the arms and legs.  The patient's pinpoint rash persisted.  The patient sought unspecified medical attention.  Additional information has been requested.
"Covid Arm" : ie. a roundish red patch at injection site.  Seemed swollen.  slightly bigger than a quarter the first night, but grew to the size of a baseball.  Red and itchy..  It has been 4 days and now it is lightening to a pale pink and doesn't feel swollen anymore.  Still itchy but seems to be improving.
Pericarditis. Patient developed symptoms 4-5 days prior to ED visit on 6/28/21. Patient was discharged home on prednisone and colchicine.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 30-MAR-2017, the patient was vaccinated with improperly stored dose of PROQUAD lot # M033209, expiration date 09-JAN-2018, albumin status recombinant human albumin (rHA) (dose, route and site of administration were not reported). No adverse effects reported. Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. There was no previous temperature excursion reported. Data logger was involved. This is one of several cases received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA004113: US-009507513-1611USA011831: US-009507513-1705USA009742.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 65-year-old female patient who received SHINGRIX (batch number G2ZF2, expiry date 22nd March 2021) for prophylaxis. Co-suspect products included PREVNAR 13 for prophylaxis. The patient's past medical history included shingles. On 1st October 2018, the patient received the 1st dose of SHINGRIX (intramuscular) and PREVNAR 13. On 2nd October 2018, 1 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The pharmacist stated that the patient received SHINGRIX on left deltoid. On the same day, the patient also received the PREVENAR 13 in her right arm. The next day, the patient broke out with Shingles blisters on her nose and on her hand. At the time of reporting, the patient had now recovered. No further details were provided at time of reporting.
Within 5 minutes of receiving the injection, I experienced the following symptoms; Sweats and chills Shortness of breath Nausea Dizziness Volatile blood pressure readings (dropped to 70/40 back to 135/80) Lack of energy The nurse used 4 ice packs to cool me down, gave me tangerines and water. This helped, it took about 20 minutes for everything to normalize and I left the facility.
Large, red area at injection site on right lower extremity. No treatment given. Resolved by 4th day.
Patient became very dizzy and light-headed a few minutes after receiving the vaccine, and fell to the ground. Patient reported feeling dizzy and was very pale. He did not lose consciousness. We helped him to a chair and observed him for another 30 minutes. He was given some water and candy. After 30 minutes, the color returned to his face and he reported feeling better.
Initially had redness, itching & soreness at injection site. About 24 hrs later had increased redness & swelling. Also had chills, felt achy & had a headache. These symptoms continued for about 48 hrs. Took Ibuprofen 600mg BID & topical Benadryl. Perspired last night, no headache or chills today. Arm at injection site less red but still sore to touch.
Covid19 breakthrough.  1st vaccine received on 08/23/2021.  34 y/o male with PMHx of Type 2 Diabetes presents to ED with c/o intractable Nausea, Vomiting and Diarrhea.  Pt also endorses fevers, diffuse abdominal pain, generalized muscle aches and poor po intake.  Temp max in ED 101.2, room air sat 99%.  Pt treated with steroids.
The same day after the vaccination my arm started hurting. The pain got worse and within a month both arms started hurting. The left arm hurts worse than the right. I went to the doctor in June, and they recommended me to do physical therapy. The physical therapy was working but I had to stop because I did not have time. I went to the doctor again by that time I couldn't lift my left arm up. I had an MRI and X-ray of my shoulder. I was diagnosed with calcific tendonitis.
Tachycardia, sweating, confusion, itching, nausea and  hypotension beginning approximately 3 minutes after vaccination. Epi-pen used as well as Allegra given. Transported to hospital and given steroids and IV Benadryl. Released after 4 hours but approximately 30 minutes later began experiencing tachycardia and sweating along with nausea again. Returned to ER and admitted. Released after 2 days.
Convulsive syncope (fainted for a couple of seconds) - I have never fainted in my life before this
After receiving the Shingrix vaccine, I felt ill and feverish for 4-5 days. And my injected arm was sore for 7-8 days
Dizziness, Headache, NauseaVomiting, Injection Site Soreness day 1-3, Headache,  Dizziness, Nausea day 3-6 Narrative:  Other Relevant History:
Vaccine may have been compromised due to temperature excursion event. Report filed with Pfizer. We are waiting for a response. No adverse reaction reported.
Shingles; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a 71-year-old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On unspecified date in 2009, the patient was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis by unspecified provider at the drug store. On unspecified date in 2009, as a result of zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered shingles, including any and all of its sequelae. As a result of the patient's receipt of the zoster vaccine live (ZOSTAVAX) vaccine, she had been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. As a result, the patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which were permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. The patient required and/or would require more health care and services and did incur medical, health, and would in the future be required to obtain further medical and/or hospital care, attention, and services. The patient has incurred and will continue to incur medical and related expenses. The patient suffered and will continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. The outcome of the event of shingles was determined to be not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The event of shingles was determined to be disabling.
Redness at injection site; Swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE SWELLING (Swelling at injection site) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03H821A and 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE SWELLING (Swelling at injection site). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE SWELLING (Swelling at injection site) outcome was unknown.            The patient was taking concomitant medication but did not specify the name. Action taken with mRNA-1273 in response to the events was not applicable.
Patient reported feeling lightheaded after administration of Flublok. Patient became unconscious with profuse sweating, but was maintaining normal breathing on his own. Patient regained consciousness on his own and was given water to sip and towels. Patient recovered from the Flublok vaccine and requested to proceed with the Spikevax administration.  Patient tolerated the Spikevax administration. Patient was able to leave the pharmacy/store with his wife without any further incident.
Syncope 15 minutes following vaccine.    Epipen administred. Subsequent ER visit.
Patient developed left posterior pain and swelling (4x5 cm) erythematous induration 48 hours or less at the injection site. Low grade fever 99.6 F.
Tested positive for covid 19. Took test on 4/14 and 4/16. Both positive. Symptoms include runny nose, congestion in head, back ache, ear ache, low grade fever (99.2) loss of smell.
Received Varivax vaccine on 1/11/08.  Fever on 1/19/08 102.  Low grade on 1/20/08.  1/22/08 - cranky, no fever.  1/23/08 - cried for 2 hours, no fever, 1 small bump on right cheek.  1/24/08 - left arm with red papule at vaccine site, right cheek with 8 red papules.  Seen in office.  Impression - Varivax rash.
By the afternoon on Sunday April 3. Slept with extreme weakness. Had a hard time getting up. By evening had a hard time raising arms to take off sweatshirt. Awake and extreme muscle and joint pains with both arm pit lymph nodes swollen. Stayed in bed all Monday with ibuprofen. Difficulty moving. Woke up tired but otherwise fine today. Very strange how it was my entire body and then fine today.
patients have been administered doses while the temperature excursion assessment was ongoing; patients have been administered doses while the temperature excursion assessment was 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 doses while the temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing) in an 89-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 doses while the temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided.  No treatment information provided.
Severe flu-like symptoms with headache, chills, body aches, sinus congestion, weakness, and malaise. Patient has been treating symptoms on his own but has reached out to this office and to his provider.
Nodule left at site of injection right anterior thigh. Slight raised irregular macular. Some almost papular areas present on both thighs and upper arms. Scattered areas, fewer on trunk.
received my shot at 8:15 am, within approximately  45min I felt a very slight heaviness to my breathing something similar to allergy season belreathing, and a slight headache on my rr temple. This was nothing that stopped me or slowed me down that day.   At approx 10:30pm I awoke from a deep sleep with SHARP chest pains, at 11pm chills, 1am fever and discomfort, 2am muscle aches.  I slept on my left side to keep blood circulating to my heart which seemed to ease some of my discomfort. My first night was rough. I awoke Thurs (12/24) with a swollen left foot and leg. some rt leg pain, joint pain in my left knee. I pushed myself to get up and move and go about my day. Friday, I still had a little left foot foot swelling and pain, knee pain, but kept pushing. The handout says if symptoms persist for longer than 24-48 to seek medical care, I have not.  Friday, (12/25/20)was Christmas and much of the day was non eventful. At approx 530pm. I felt a bulging not in the center of my chest which was tender to the touch. This concerned me. I gently messaged the area, rested a bit but continued to move up and down the stairs. That discomfort and the bulge decreased within a few hours.   Saturday, (12/26) 4:am and I have notice much of the swelling in my foot and legs has decreased, however, I now have bruising. The sore arm is gone, and I am hopefully, all is well. I forgot to mention, I have had intermittent persistent cough with slight sob, something similar to the start of allergy season, but it is brief. I have been coughing at night. I have a history of whooping cough. And gastric bypass.
26jun90 pt vax hepta B. same day pt devel rash on front of chest and inner aspect of wrists. rash not itchy and gradually faded over next 2 week. pt elected not to continue series.
Sudden loss of hearing in right ear in upper frequencies, pressure and fullness in inner ear for 2 weeks straight now.  Nerve damage to left ring finger tip with less feeling to touch.
Patient had swelling, discomfort, and redness beginning on the evening of the shot. Two days later the redness has now spread but still contained on the upper arm.
PT received COVID vaccine. PT was accompanied by her mother. PT stated she had a history of fainting post receiving vaccines. PT immediately felt dizzy and experienced syncope. PT was laid down on the ground and EMS immediately responded. Foxborough fire/rescue also arrived on scene to evaluate and treat PT. PT regained alertness and was assisted on to a wheelchair so that she may be moved to an area for further evaluation. PTs condition improved. PT decline transport and was released to her mother after.
Within 5 minutes of administration of below listed 4 vaccines & ibuprofen exhibited symptoms of allergic reaction, began wheezing, required supplemental O2; albuterol & epinephrine administration & was transferred to ER.
Pt was sleeping and found not breathing, with gray-blue coloring. Responded to tactile stimulation. Called 911. Evaluated in office and admitted for observation. Normal exam. Possible "near sids".
Rash on torso, face and legs starting 2 days after injection.  Prn Zyrtec as antihistamine
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, pertinent medical history and concomitant medications were not reported. On unspecified dates, unspecified patients were administered with an improperly stored VAQTA (dose and route of administration were not provided; lot # was reported as L001068 with expiration date on 02-NOV-2017). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
No addtional AE; Inadvertently concomitantly administered PROQUAD and VARIVAX; This spontaneous report was received from a medical assistant referring to a 1-year-old patient. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not provided.   On 03-FEB-2022 the patient was vaccinated with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) 0.5 (lot number U015481, expiration date 13-NOV-2022 ; vaccination scheme, route of administration, and anatomical location of vaccination were not reported) and varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 (lot number T028305, expiration date 20-AUG-2022) for prophylaxis. On same day, medical assistant reported that measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) and varicella virus vaccine live (oka/merck) (VARIVAX) were inadvertently concomitantly administered to a one-year-old patient (inappropriate schedule of product administration).  No product quality complaint (PQC) and no additional adverse event (AEs) (no adverse event) was reported.
Admit for weakness, fevrs, falls at home. Hx of HTN, Alzheimers. Did not require hospitalization for COVID-19, but admitted d/t acute metablic encephalopathy and confusion. No PNA or hypoxia. Tx w/monocloncal antibody infusion in ER. Pt DCd back to baseline.
I gave a booster vaccine that was hours after expiration date of opening. Pfizer notified by my manager and stated per their data no further action or vaccination needed.