chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I was diagnosed with COVID on 13May, this year; I was diagnosed with COVID on 13May, this year; 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), on 13Jan2021 as dose 1, single (Batch/Lot number: unknown), on 11Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 15Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: COVID-19 (medically significant) with onset 13May2022, outcome "unknown", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "I was diagnosed with COVID on 13May, this year". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13May2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Information:Patient was diagnosed with COVID, Patient have had 3 vaccinations.My heart rate was low.I was given some heavy chest pain symptoms; I am in pain.Reason for no lot number of Paxlovid Consumer further stated, "Expires Feb2023, number on the pack, Lot number was 6C7457. It is GO07457."Consumer stated, "Well I was diagnosed with COVID on 13May, this year and they give me the medicine Paxlovid and since then I have been feeling fine. The medicine was strong, strong strong. It really helped the symptoms that I had, I never had to go to the full lay in bed, I laid in the bed for couple of day. Well it was the third COVID shot (Pfizer COVID-19 Vaccine) that knocked me out. That COVID shot was so bad that I had a heart attack with it. My heart rate was low and I had a second heart operation and in the past three weeks, four weeks, I was given some heavy chest pain symptoms and I am trying to find out can I get a prescription refill as a preventive measure."Consumer stated, "No, not that long please. I am in pain and I want to lay down well and rest myself."LOT#: Consumer stated, "It was 150 mg. Old white pack 3CL/PFFE. They covered it up."LOT# (Pfizer COVID-19 Vaccine): Consumer stated, "No no I got a card. It knocked my symptoms in a day or two. They advised to take all the medicine which I did too. I have back in 13May. The first dose was on 13Jan2021 the second dose was 11Feb2021 and third dose was 15Nov2021 and the LOT# is 069F look like 2TH. It could be an A or H."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Child given flu vaccine, fainted after vaccine administered. Child placed down on cool floor and feet raised on his back, his skin was pale, but he came to quickly, responsive, school nurse sent him home. I called the parents this morning, left message for call back, as they did not answer, then called school nurse, child is back in school and doing well today as reported by school nurse.
Information has been received from a pharmacist concerning her 12 month old white healthy son with no none allergies or medical history who on 25-AUG-2006 was vaccinated SC in the right leg with a first dose of Varivax (lot # 654331/0491F). Concomitant vaccination on the same day included a third dose of hepatitis B virus vaccine and a fourth dose of PREVNAR> Concomitant medication included fluoride. There was no illness at the time of vaccination. On 08-SEP-2006, the patient went to bed and it looked like a rash was starting. The next morning, the patient had a rash all over the groin, buttocks, the crease of the legs, and up the child's back. The reporter described the rash as pink spots with scattered vesicular bumps. He had greater than 100 lesions. The pharmacist reported that no new soaps, diapers, or detergents were used. The patient was seen by a nurse practitioner who thought it was diaper rash the pharmacist believed it was related to Varivax. The patient had a low grade fever of 100 degrees Fahrenheit. No itching was noted but the patient was very uncomfortable and did not sleep much that week. The lesions were cleared within one week. The pharmacist reported that there had been wild-type chickenpox in the area but she did not believe that he was exposed to anyone. The patient recovered on 16-SEP-2006. A product quality complaint was not involved. Additional information has been received from the pharmacist who reported that on 08-OCT-2006, her son had approximately 100 lesions mainly in his diaper area, front and back. Some were on his back, bottom of his feet, and arms and neck. It lasted about one week. He also had a fever, was cranky and uncomfortable, and slept two hours maximum each night. The patient recovered. No further information is expected.
terrible taste/some odd taste on her mouth (salty like)/mouth taste really strange/bad taste in my mouth; also aching in her tooth and tingling on her lips; also aching in her tooth and tingling on her lips; This is a spontaneous report from a contactable retired nurse (patient). A 71-years-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA Vaccine, Solution for injection, Batch/Lot number: ER8732; Expiration Date: 31Jul2021, NDC and UPC number was unknown), via an unspecified route of administration on 31Mar2021 as dose 2, single (at the age of 71-years-old) for covid-19 immunisation. Medical history included cancer from an unknown date and unknown if ongoing. Concomitant medication(s) included tamoxifene citrate taken for cancer, start and stop date were not reported. Historical vaccine included patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EN6206 and Expiration Date: 30Jul2021, NDC and UPC number was unknown), via an unspecified route of administration on 10Mar2021, as dose 1, single (at the age of 71-years-old) for covid-19 immunisation. Patient stated she saw on the news a couple days before she received the second dose that people had been complaining of their mouth being full of metal and nickel after the vaccine. On 31Mar2021, since her vaccination, patient had terrible taste, odd taste in her mouth (salty like), really bad taste in my mouth, mouth taste really strange, her lips kind of like salty all the time and also had aching in her tooth and tingling on her lips. Patient had no idea what to do, she gone to infectious disease doctor, she had no idea no idea, she mentioned that she had just gotten her vaccine, doctor said well it might be but you knows nobody knows we were in pandemic. Patient stated that she also had an endoscopy this past Wednesday (28Apr2021) at the hospital. Patient stated that odd taste in her mouth was still persisting today (04May2021), and she doesn't know when it will go away. Causality reported by the patient, patient stated that it must be, it had to be, because nothing else in her life had changed, and when she got the second dose then she had this odd taste in her mouth, that she thought it will go away and it had not yet. Patient would like to know if these side effects had been reported before, like to know if her side effects were caused by the vaccine how long will it last. Patient stated that it was not fun to eat anymore due to the taste in her mouth and was concerned about an odd taste in her mouth. The outcome of terrible taste/some odd taste on her mouth (salty like)/mouth taste really strange/bad taste in my mouth was not recovered and unknown for rest of the events.  No follow-up attempts are needed. No further information is expected.
doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) in a 94-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021 at 1:38 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 1:48 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.    Vials only punctured right before administration.  No treatment medication was provided.   This case was linked to MOD-2022-566976 (Patient Link).
The varicella vaccine was administered on 12/01/2016 with redness at injection sight immediately.  On 12/15/2016 at the injection sight on the left thigh there  was a 1" diameter inflamed and raised spot. This spot reamaind for approximately four days.  The spot was red, hit to the touch, and raised.  It resembled a chicken pox sore.
Pt. had MMRV on 8/15/11 and Mom called on 8/18/11 and stated pt. has approx. 2 inch red raised area to the back of right arm where MMRV was given.  Also stated pt. began vomiting on the evening of 8/16/2011.
No additional adverse events reported; VARIVAX was administered after improperly stored; This spontaneous report was received from a medical assistance and refers to a 12 month old patient of unknown gender. The patient's concurrent conditions, pertinent medical history, drug reactions or allergies and concomitant mediation were not reported.  On 08-SEP-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml, lot number T027303 with expiration date 12-AUG-2022 for prophylaxis, which was improperly stored at a temperature of 6°F to 14°F (5.8F) for 0 hours, 18 minutes and 0 seconds; and 6°F to 14°F (11.9F) for 1 hour, 0 minutes and 0 seconds; for a cumulative timeframe of 1 hour and 18 minutes. There was no previous temperature excursion. No additional adverse events reported.
no adverse event; incorrect product storage; This spontaneous report was received from an administrator, referring a female patient. The patient's pertinent medical history, current conditions, previous drug reactions or allergies were not reported.  On 05-OCT-2020, at the age of 4-year-old, the patient was administered improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection (formulation, strength, dose, vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot number T003706, which has been verified to be valid, expiration date reported and validated as 30-JAN-2022), as prophylaxis (product storage error).  Also, a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR ll) was administered to the patient, lot number S029454, which has been verified to be valid, expiration date reported and validated as 19-SEP-2021.   The vaccines administered were stored at temperatures that went -14.27 degrees Celsius (C) to for a time frame of 20 minutes, as recorded by a data logger. There was no previous temperature excursion.  This is one of two reports received from the same reporter.
Nausea, fever, red arm, blisters in mouth, diarrhea.
Had an overall body rash; An overall rash with some small welt; very itchy started on my face with burning and itching; An overall rash with some small welt; it was an overall rash with some small welt, very itchy started on my face with burning and itching and then was all over to my body; This is a spontaneous report from a contactable nurse (patient). A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: 30155BA), via an unspecified route of administration, administered in Arm Right on 28Sep2021 (at the age of 75-year-old) as dose 3 (booster), single for COVID-19 immunization. Medical history included Atrial fibrillation. Concomitant medication(s) included apixaban (ELIQUIS) taken for atrial fibrillation (for blood clotting), start and stop date were not reported. The patient did not receive any other vaccination 4 weeks prior to COVID 19 Vaccine. The patient had booster shot actually on 28Sep2021 which had been, that was Wednesday. The patient wanted to report a symptom she had after having the booster shot for COVID. This morning (03Oct2021) which would be approximately four days after having the booster on Wednesday, 28Sep2021. he patient had an overall body rash which last persisted for between one to two hours and then disappeared, she had, it was an overall rash with some small welt, very itchy started on her face with burning and itching and then was all over to her body. It was reported that after 1 to 2 hours rash disappeared, she meant it was there for hour and a half to two hours, probably two hour. Stated, that's no longer a problem. That had improved, it's gone away, the rash was gone away. The patient did not receive any treatment for the rash. When asked for causality, the patient stated, she had no idea she had no way of knowing that, she was just reporting what happened, she did not know if it was related to, she just since she have had the booster she was told to report any adverse thing. It's been far enough away from the booster that she wouldn't know if that was (voice not clear) but stated who knows and she don't know. The patient had not undergone lab test in the last two weeks. Outcome of the events was recovered on 03Oct2021.  Follow-up attempts are completed. No further information is expected.
Fever 103 F, swelling at injection site approximately 8 hours after injection, nausea, and headache. Went to ER, treated with Ibuprofen and stayed for observation 24 hours. All symptoms were resolved the next day 1/14/10.
Information has been received from a physician concerning a 14 year old daughter with asthma, and allergies to penicillin and amoxicillin who 1 and ? years ago (in November 2008), was vaccinated intramuscularly with a pediatric dose of VAQTA. On 15-MAY-2010, the physician administered her daughter's second pediatric dose of VAQTA in her right arm. Concomitant therapy included montelukast sodium. Subsequently, her daughter developed swelling of the injected arm about 8cm. The physician mentioned that her daughter had swelling after every vaccination, but the worse than others before. Her daughter developed a bilateral tic of the periorbital muscles on Sunday (16-MAY-2010). She also stated that she was better today but not resolved. No laboratory diagnostics studies were performed. Additional information is not expected.
Pain began in shoulder shortly after injection. Paint severe by 10PM. Awakened during the night if rolled on shoulder. 2/3 AM shoulder hot to touch, swollen, red splotches, severe pain. Symptoms continued to increase. Saw MD at 121:15AM and rechecked at 3PM put on Augmentin, 7 day therapy.
20 minutes after PENTACEL, parents report rash head to toe, patient never seen in office for rash. No respiratory distress.
Clinic 1 (28 days ago) administered Moderna to 17 years old, the clinic lead notified me today,01/27/21, that she was in the process of doing data entry for the 2nd dose of Moderna COVID vaccine, and she noticed that the patient is 17 year old. When the data entry was done for the first dose on 12/30/20, the prescription went through and the pharmacist verified and administered the vaccine without noticing that the patient is younger than 18 years old.  The mother did consent for the first dose. The clinic lead explained the incident to the mother on 01/27/, the mother did consent and asked for the 2nd dose of COVID vaccine to be administered to her daughter.
Presented 11-6-15 with redness of left arm at injection site about 4-5 cm diameter also redness about 5-6 cm diameter just below 1st site on inner aspect of arm and minimal swelling c/o some pain. Noticed redness 11-4-15.
Patient, reports that she had an exacerbation of her Myasthenia Gravis after receiving Pfizer on 7/22/2021. Was advised by her healthcare provider to receive the J&J Janssen vaccine to complete her series and to avoid further mRNA vaccination. Email sent to Covid19 vaccination team explaining and detailing the situation on 8/26/2021 and reply on 8/26/2021 from with (privacy) Bureau of Immunization and TB confirming okay to administer J&J to complete series as long as it will be at least 28 days after previous dose. Dose administered and then call from Bureau of Immunization and TB reporting need to submit VAERS report due to administered contrary to EUA. VAERS report submitted. No untoward effects or symptoms reported by patient. Tolerating vaccination well.
HIVES; WELTS ON FACE, ARMS TRUNK, LEGS, ELBOWS, KNEE, FEET, TOES; ITCHING, SWELLING; SHORTNESS OF BREATH.  FIVE DAYS; MOSTLY AT NIGHT TO LATE MORNING.  BENADRYL
Hives post vaccine administration (within 5 min).  No shortness of breath.  BENADRYL 12.5/5 1/2 tsp given -> hives resolved ( < 1 min).
PRURITIC RASH ON BILATERAL ELBOW, SEEN BY PA ON 9MAY14- CONSULTED DR. VIA TELEPHONE/EMAIL THE SAME DAY. TREATED WITH TOPICAL STEROID AND PO ANTI-HISTAMINE
12/13/22 pt brought to ED with c/o not feeling well last few days, decrease in appetite; bilateral LE edema; found to be in worsening renal failure; 12/21/22 pt had a positive COVID test; acute on chronic hypoxic respiratory failure secondary to COVID 19; diastolic heart failure; pulmonary edema; pleural effusion; on Vapotherm; thoracentesis bilaterally; poor prognosis; DNR; pt's condition worsened; increase in hypoxia; transitioned to comfort care and pt expired in the hospital
Red rash below injection site; Soreness below injection site; This case was reported by a consumer via call center representative and described the occurrence of red rash in a 58-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on an unknown date).   On 16th June 2019, the patient received the 2nd dose of Shingrix. On 18th June 2019, 2 days after receiving Shingrix, the patient experienced red rash and pain. On an unknown date, the outcome of the red rash and pain were unknown.   It was unknown if the reporter considered the red rash and pain to be related to Shingrix.  Additional details were provided as follows: The patient experienced rash below injection site and soreness below injection site after receiving 2nd dose of Shingrix vaccine.
Within 48 hours of the shot I experienced heart palpitations. Upon taking my blood pressure it was extremely elevated; as much as 185/110. This lasted for several days until I saw my doctor and received a higher dose of lisnopril than I normally take. At the time I did not realize the symptoms were most likely due to the vaccine.
Child presented to clinic on 4-9-07, 4 days following vaccination with redness, itching & welting at site of injection
Within 4 hours after the vaccine, I had extreme fatigue which progressed over the next 4-5 days. I describe this as narcolepsy, but a sleep study was not done. I was put on modafinil 100mg by my primary care doctor. I took that 2 mornings in a row and was up for 5 days straight unable to sleep even with taking my sleep medications at night. After the second day, I discontinued the modafinil. During this time, I was unable to work, drive pretty much anything in fear of falling asleep. The symptoms eventually resolved.
From initial information received on 03/30/04 from a medical clinic, regarding an adverse event occurring in the USA, it was reported that a 10 year old male patient received Daptacel, lot number C1527AA, administered in the right deltoid, and Fluzone SV '2003-'2004 USP, lot number U1129AA, administered in the left deltoid on 03/30/04. The dose of Daptacel was given in error. After the vaccinations, the patient felt ok, went to school, and passed out while waiting in the lunch line. Soreness was noted at the injection site of the Fluzone vaccination. The patient reportedly did recover from this event.
11pm Itching began,  along with massive amount of Large and small hives and rash on back and chest, buttocks;  face, arms, stomach and legs milder rash
diagnosed with atrial fibrillation; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (diagnosed with atrial fibrillation) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 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 ATRIAL FIBRILLATION (diagnosed with atrial fibrillation) (seriousness criterion medically significant). The patient was treated with APIXABAN (ELIQUIS) at a dose of UNK, blood thinner. At the time of the report, ATRIAL FIBRILLATION (diagnosed with atrial fibrillation) outcome was unknown.            No concomitant medication was reported.  It was reported that almost immediately after receiving the vaccination, patient got diagnosed with atrial fibrillation. Patient's heartbeats are erratic and needed surgery after two years. Patient had exact symptoms of myocarditis and pericarditis but it had not been diagnosed. Patient was scheduled to have an ablation.  Company comment- This spontaneous case concerns a 76-year-old female patient with no reported medical history, who experienced unexpected, serious (medically significant) AESI Atrial fibrillation, which occurred at an unknown time with regards to vaccination with a second dose of mRNA-1273. After vaccination, the patient complained of erratic hearts beats and was diagnosed with atrial fibrillation. Current treatment is with Eliquis and was scheduled for ablation but claims she'll be needing surgery after 2 years. The husband stated that although her wife has the exact symptoms of myocarditis and pericarditis, she was not diagnosed with it. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 76-year-old female patient with no reported medical history, who experienced unexpected, serious (medically significant) AESI Atrial fibrillation, which occurred at an unknown time with regards to vaccination with a second dose of mRNA-1273. After vaccination, the patient complained of erratic hearts beats and was diagnosed with atrial fibrillation. Current treatment is with Eliquis and was scheduled for ablation but claims she'll be needing surgery after 2 years. The husband stated that although her wife has the exact symptoms of myocarditis and pericarditis, she was not diagnosed with it. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.