chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patients recieved the Moderna COVID-19 vaccination after the expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients recieved the Moderna COVID-19 vaccination after the expiration date) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     The patient's past medical history included SARS-CoV-2 test positive on 29-Apr-2020. Concurrent medical conditions included Allergy to NSAIDs.    On 17-Dec-2021 at 3:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 17-Dec-2021 at 3:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients recieved the Moderna COVID-19 vaccination after the expiration date). On 17-Dec-2021 at 3:00 PM, EXPIRED PRODUCT ADMINISTERED (Patients recieved the Moderna COVID-19 vaccination after the expiration date) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, Vital signs measurement: stable (normal) Stable.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Treatment information was not provided.  Patient was recalled and was found to be stable..   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2021: Significant follow up , Patient details (Height, weight) Medical history got updated. On 27-Dec-2021: Followup received on 27 Dec 2021 contains no new information.
I developed like a bruise and the slight skin discoloring at the spot of the, at the spot of the vaccine, where the injection was injected; I developed like a bruise and the slight skin discoloring at the spot of the, at the spot of the vaccine, where the injection was injected; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 13Dec2021 (Lot number: 33130BA) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 13Dec2021, outcome "unknown", described as "booster"; VACCINATION SITE BRUISING (non-serious), VACCINATION SITE DISCOLOURATION (non-serious), outcome "unknown" and all described as "I developed like a bruise and the slight skin discoloring at the spot of the, at the spot of the vaccine, where the injection was injected".  Additional information: Consumer stated, "I am Calling, regarding, So, I got a booster shot a week ago and I developed like a bruise and the slight skin discoloring at the spot of the, at the spot of the vaccine, where the injection was injected and I mean, I would think that it would go but it sort of become bit more prominent now so, I was wondering what my options are, How do I consult someone for this". Product conformed-COVID 19 Vaccine(Booster).  No follow-up attempts are possible. No further information is expected.
developed severe sweating; profuse sweating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old male patient received BNT162b2 (BNT162B2), on 01May2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 81 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, Unknown Manufacturer), for Covid-19 Immunization; Covid-19 vaccine (First Booster , Unknown Manufacturer), for Covid-19 Immunization. The following information was reported: HYPERHIDROSIS (non-serious) with onset May2022, outcome "recovered" (May2022), described as "developed severe sweating"; HYPERHIDROSIS (non-serious) with onset May2022, outcome "recovered" (May2022), described as "profuse sweating". Therapeutic measures were not taken as a result of hyperhidrosis, hyperhidrosis.  Additional information: Reason for no lot number: of COVID-19 Vaccine: Other: Consumer stated, "The LOT number is PF, I can hardly read it the pharmacist did not write too well, it looks like 2 and I can't make out what next is and then it says FM88 no could be 9992 could be 8882 not sure which." Expiry Date of COVID-19 Vaccine: Unknown, Other Products: Yes. Additional Context: Consumer stated, "I had my second booster (Later clarified as Pfizer COVID-19 Vaccine) on Sunday of 01May2022 at (withheld) in (withheld) where I live and a day or two after that I developed severe sweating, profuse sweating and it lasted almost 2 days and I believe it was from shot because it is totally gone now." When paraphrased the concern: Consumer stated, "Yes, it's gone, I checked with my GP and he said very well it could be." Consumer was informed about the Pfizer drug safety department. In response: Consumer stated, "Absolutely I want to help as much as I can." Height and weight: Consumer stated, "My height is approximately 5'9 I would say roughly. "Time of Vaccination: Consumer stated, "Around 2pm in the afternoon."  The information on the batch/lot number for (BNT162B2) has been requested and will be submitted if and when received.
Chills,low grade fever, fatigue,body ache,generalized body malaise,sore throat,severe headache,nausea,difficulty of breathing,shortness of breath,congestion,runny nose and severe headache.
This spontaneous report as received from an 80 years old male consumer with penicillin allergy, diabetes and heart problems reporting on himself. The consumer was vaccinated with a dose of ZOSTAVAX (Lot # not reported) SQ on 01-SEP-2012. No other co-suspects were reported. Concomitant medications included metformin, COUMADIN, omeprazole, doxazosin mesylate, "liberide", PLAVIX, valsartan, atenolol and "atervista". The consumer reported that on 03-SEP-2012, he experienced a symptom like a blocked artery. He stated that he was having trouble getting his breath, and had no symptoms before the vaccine. He also stated his physicians were unable to treat. The patient did not receive treatment for the adverse events. There were no Lab diagnosis or studies performed. The outcome of blocked artery and trouble getting his breath was unknown. Additional information has been requested.
Moderna vaccine was stored in refrigerator, not freezer. Then given after the 30 day expiration.
Mom called on 3/15/01 and states that child broke out with chickenpox.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 20-OCT-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB (exposed to the following temperatures and cumulative time frames colder than 36F: In September of 2015, the coldest temperature was 34F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34F for 192 hours, for a total of 1,031.3 hours (43 days)) with lot number: L010595, expiry date: 12-NOV-2016 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
113 Bivalent doses administered after the BUD to patients 12 and up.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received 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 EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event). At the time of the report, NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.).    No concomitant medications were reported.  It was reported that 113 Bivalent doses were administered after the BUD to patients 12 and up. 51 doses were administered from Lot AS7140C, and 60 doses from Lot AS7148B.  No treatment medications were reported.
PATIENT CAME IN FOR A BOOSTER DOSE AND DURING THE ADMINISTRATION PROCESS, THE TECHNICIAN UPON INJECTING THE PATIENT, REALIZED THAT THE VACCINE WAS LEAKING OUT OF THE LUER LOK PORTION OF THE SYRINGE. WE DO NOT BELIEVE THAT THE PATIENT GOT THE ENTIRE DOSE OF THE VACCINE
Reports left arm pain, redness, chills, fast hearbeats and low grade fever. fast hearbeats resolved.   Advised pt to be seen to follow up. She declined. Stated will wait for one day if worsening she will go to the WIC.
Arthritic pain of knees, ankles, 8/10 severity, lasted for approximately 4 weeks with decreasing severity from the vaccine. Did not seek treatment for adverse effects. Paresthesias and polyneuropathy exhibited by a numbness proximal to bilateral knee joints. Establishing care with primary care provider 01/19/2022 and evaluation is ongoing.  Blood work including CBC, CMP, A1c will be ordered and EMG will be pursued if no findings identified on routine blood work and symptoms do not improve.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Reynauds" (unspecified if ongoing); "Sjogrens" (unspecified if ongoing); "MGUS" (unspecified if ongoing); "Celiac" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tetracycline, reaction(s): "known allergies: tetracycline". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19: Paxlovid from 09Aug2022 to 14Aug2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
It started out with high fever. My thermometer was dead so I couldn't take my temperature and it lasted for 36 hours. It came in phases. First phase I was hoarse and a minor scratchy, sore throat. I also had muscle aches and pains with the fever. It last until 05/09/2022. On 05/10/2022 I called the doctors office. They sent me to another area for a test on that Tuesday. I got tested and then went back home. My sore throat got worse. By 05/15/2022 my teeth were hurting even while brushing my teeth. I started getting a cough by Thursday. I felt like I was getting better and then the Health Department contacted me on 05/15/2022. They told me I would need to isolate until 05/16/2022. I had to go for groceries because I had no one to pick any up for me. The cough was gradually getting better. I also lost my sense of smell.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); 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 (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 61-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  It was reported that there have been no power outages that would have impacted the Moderna vaccine. However, reporter reiterated that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger that caller was unable to download for the months of DEC2021, JAN2022, and FEB2022. Reporter said that they are filling out a temperature excursion assessment with the State at this time and she was calling in to report the same to Moderna.  Reporter confirmed that patients have been administered doses while the temperature excursion assessment has been ongoing. It was reported that no adverse reactions were reported by any patients.
had the shot and got it so did my husband/ Suspected Vaccination failure; got it so did my husband groin area not happy; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient's wife. The age at vaccination was not reported. The reporter stated that, did her husband's groin area not happy. The reporter stated that the patient had the shot and got shingles in groin area. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided. This case has been linked with case US2021AMR178369, reported by same reporter for reporter herself.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR178369:Same reporter
I visited hospital on 1/19/06 as a new patient. During the course of the visit the nurse insisted 3x's I get the tetanus/diphtheria vaccine. I agreed after she asked me to do it on the third time. My reaction was severe vertigo and nausea about an hour after receiving vaccination. (around 12:00pm) By 6:00pm I couldn't stand up anymore. I could only lay down and basically sleep. Everything would spin and I was sick to my stomach. Like NOTHING I have ever felt before. I know for a fact in my 48 and 1/2 yrs. that I've had a Td shot before and I've never had a reaction to it. I called a pharmacist about 9pm. He told me it was a rare reaction and it would be about 48 hrs. til I felt better. I didn't have 48 hrs. This was on a Thursday and I work a double shift on Fridays at a health club and then we were leaving that Friday night at 7pm for a trip out of town. I couldn't move. I then called the hospital where I received the shot and asked for the emergency Dr. on call to call me immediately. He did and told me also it was a rare reaction and to get a good nights sleep and I would probably be better in the morning. He also told me not to get another Td shot EVER again. The next morning I still felt the same. Vertigo in my head, very dizzy and lightheaded and very nauseas. I could not go to work. I called back at 9am the next morning and asked them to prescribe me something to counteract this reaction. They prescribed me Meclizine Tabs 25mg and Promethazine Tabs 25mg. By 2:30pm I finally got my RX's. I took the meds and went to sleep. By 6:30pm that night (Friday) I felt a little better but not much. I took a shower and we drove out of town that night. On Saturday, I still had to move slowly because if I didn't, it felt like I left my head behind me. It is Thursday AM, 1/26/06 and last night when I went to bed, I laid down and still had to focus on something because I still felt a little dizzy. Today I feel pretty good but what happened? They gave me a reaction sheet and it only said soreness or whatever in the arm I got the shot. My arm really never hurt. I got the vertigo and nausea instead. The pharmacist and on call emergency doctor both said my reaction is so rare that they don't put it on the reaction sheet. I feel it SHOULD be on there. Also, when I called the Dr.'s office the next day, after the shot, they told me it was a viral. Well I certainly felt fine when I went in there on 1/19. FYI on January 3rd we flew home from out of town and I had the chills and aches and was in bed for a day. I guess flu like symptoms. But I was fine by that Friday. What happened to me and the Dt vaccination?
patient began experiencing insomnia after her first vaccine. She didn't think much of it, thinking it would subside over the next few days or week. Patient received second vaccine and still is having insomnia. It is now June and she can't get a full night of sleep. Patient has not had this issue before receiving the vaccine.
Vaccines given 2/12/07 fever, irritability 2/14/07 onset rash 2/4/07 and progression symptoms 2/15. Temp 103+ skin flushed and maculopapular rash.
severe sensorineural hearing loss; viral conjunctivitis; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a male patient of unknown age. His concurrent conditions, medical history and concomitant medications were not provided. In or around 14-APR-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dose, injection anatomical location and route of administration were not reported), for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), he suffered sudden hearing loss in his left ear and was diagnosed with severe sensorineural hearing loss (deafness neurosensory). The patient also suffered sudden bilateral blurry vision and decreased vision and was diagnosed with viral conjunctivitis. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX), his symptoms had resulted in physical limitations not present prior to using the vaccine. He also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, he suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, he had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome for all the events was not recovered. The reported considered all the events to be related to zoster vaccine live (ZOSTAVAX).  It was considered that the deafness neurosensory and viral conjunctivitis were disabling events.  Upon internal review, the deafness neurosensory was a medically significant event.
Vaccination given in right deltoid, blood spurted out of site, hematoma formed at injection site, pressure applied, no further bleeding.
This spontaneous report was received from a nurse practitioner concerning to unspecified patients of unknown age and gender. No medical history or concurrent conditions were reported. On an unknown date, PROQUAD (Merck) was exposed to temperatures of -2.3 C for 4 hours and 20 minutes. At the time of the report, it was unknown if the vaccine was applied to patients. This is one of several reports from the same source. Additional information has been requested.
Five minutes after patient received Covid vaccine, he began to feel light headed. Patient had no syncope, but felt clammy and hot. Patient to EMS room and once supine, symptoms resolved. Patient given a snack and juice.