chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 4:27 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 4:27 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 67.50 for dose administered on 27-Oct-2021. No concomitant medications were reported.  Batch number 035C21A underwent temperature excursion on 27-Oct-2021. 2 vials with temperature 29 degrees Fahrenheit at 09:00 AM which were moved to fridge on 29-Sept-2021 and beyond used date was 29-Oct-2021. 4 vials with temperature 32 degrees Fahrenheit at 10:00 AM which were moved to fridge on 05-Oct-2021 and beyond used date was 04-Nov-2021. Product moved to clinic on 27-Oct-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. Temperature recordings were taken using a temperature monitor at every hour. No treatment medications were reported.
Rash, tenderness, swelling, redness, inflammation. Evening onset while sitting. After 12 hours of onset has decreased.
Pt developed hive on his L Forearm. Pt given 25 mg Bendryl
pt recvd vax;subsequently was noted expiration date of vax had passed;no problems at time of report;
going through shingles right now who had the vaccine./Suspected Vaccination Failure; going through shingles right now who had the vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 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 was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient's friend. The age at vaccination was not reported. The patient received the vaccine and was going through shingles at the time of reporting. The reporter said who knew, hoping it prevents a severe case. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available.
PATIENT SAID AFTER THEY WENT HOME THEY STARTED FEELING A ITCHING SENSATION OVER THE WHOLE BODY AND INJECTION SITE WAS SWOLLEN.
Normal arm soreness immediately after vaccines. 34 hours later, my left arm became weak, pain worsened and spread to left hand and my fingertips started to tingle.
Swelling in deltoid muscle, in inner arm above elbow . Pain in armpit, upper arm and inner forearm to wrist.
4/2/21 1 - non-injection arm felt frozen solid, 30 minutes 2 - concurrent with 1, severe chills, 30 mins 3 - after 1 and 2 resolved, extreme pain in both hands, 1 hour, acetaminophen and naproxen 4a - concurrent with and after 3, major headache (both sides of forehead and all sinuses),  acetaminophen and naproxen 2x more that day, loratadine, no relief 5a - concurrent with 4, aches and pains in most muscles and joints, acetaminophen and naproxen 4/3/21 4b - continued headache (both sides of forehead), acetaminophen and naproxen 5b - continued aches in pains in muscles and joints 4/4/21 8a - pale-ish red patch on injection arm, boarders not well defined, warm to the touch, below injection site, grew as day went on 5c - continued aches in pains in muscles and joints 4/5/21 8b - red patch continued to spread 4/6/21 8c - red patch continued to spread, Dr. diagnosed as cellulitis, started on doxycycline and loratidine 4/7/21 8d - red patch started going away
*Extreme Fatigue  3 alert and oriented when was ambulating  on her own.  *Mental Status Changes
mom c/o pt cried most of the noc p/vax & rt thigh very swollen;pt was seen the morning p/crying @ intervals, rt thigh sl swollen, no redness @ inj site;denied fever;
I was just going to stand up and I felt like I was hit with a lightening bolt! It was painful and only lasted a few second.
Patient received COVID19 (Pfizer) booster dose at 2:25pm from a vial that was taken out of storage at 8:15am. The acceptable time to give the vaccine was from 8:15am-2:15pm. The dose given was out of the 6 hour window in which it should have been given, and therefore the patient was given an expired dose.
Patient was given Dose #1 of the Meningitis B/BEXSERO vaccine on Monday 4/23/2018. She developed a very large red, bruised and swollen area at the injection site the same day as she received the vaccine, and the symptoms became worse as the week progressed until Saturday. She went to the school nurse to show her the arm the following week, on Wednesday 5/2, and there had been some improvement by then. I spoke with her mother today and she stated she was also feeling a little under the weather for the week, but had no fever. She said as of today most of the swelling has resolved and she just has a little bump/nodule left at the site. I recommended her check with the primary doctor to see if she should get Dose #2, and to call us if there was any worsening of symptoms.
child aged 12 y.o. with Pediatric Consent (5-11years) received a pediatric dose of Pfizer second dose. Was 12 y.o. at time of first dose as well
Stayed in bed all day; Transpiring quite a lot; Had a fever of 101F; Discomfort; Could not sleep at all that night was twisting and turning all night; Chills; Extreme fatigue/booster knocked them out for a few days; Dizziness; Having no energy at all; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Discomfort), INSOMNIA (Could not sleep at all that night was twisting and turning all night), BEDRIDDEN (Stayed in bed all day), HYPERHIDROSIS (Transpiring quite a lot) and DIZZINESS (Dizziness) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D21A, 031B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included CETIRIZINE HYDROCHLORIDE and MONTELUKAST SODIUM (SINGULAIR) for Allergy, LEVOTHYROXINE, BUPROPION HYDROCHLORIDE (WELLBUTRIN), FINASTERIDE (PROSCAR), ROSUVASTATIN CALCIUM (CRESTOR), EZETIMIBE (ZETIA), ACETYLSALICYLIC ACID (BABY ASPIRIN), UBIDECARENONE (COQ10 [UBIDECARENONE]), DUPILUMAB (DUPIXENT) and ALFUZOSIN for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced DIZZINESS (Dizziness) and ASTHENIA (Having no energy at all). On 19-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DISCOMFORT (Discomfort), INSOMNIA (Could not sleep at all that night was twisting and turning all night), CHILLS (Chills) and FATIGUE (Extreme fatigue/booster knocked them out for a few days). On 20-Oct-2021, the patient experienced BEDRIDDEN (Stayed in bed all day), HYPERHIDROSIS (Transpiring quite a lot) and PYREXIA (Had a fever of 101F). At the time of the report, DISCOMFORT (Discomfort), INSOMNIA (Could not sleep at all that night was twisting and turning all night), BEDRIDDEN (Stayed in bed all day), HYPERHIDROSIS (Transpiring quite a lot), DIZZINESS (Dizziness), ASTHENIA (Having no energy at all), CHILLS (Chills), FATIGUE (Extreme fatigue/booster knocked them out for a few days) and PYREXIA (Had a fever of 101F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Oct-2021, Body temperature: 101 (High) 101 degree fahreheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Oct-2021: Follow up received and contains No New Information
intense side effects/reactions more intense than with the second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (intense side effects/reactions more intense than with the second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F21A) for COVID-19 vaccination. Previously administered products included for Vaccination: flu shot (high dose flu shot) in 2020.Past adverse reactions to the above products included Vaccination adverse reaction with flu shot.On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Nov-2021, the patient experienced VACCINATION COMPLICATION (intense side effects/reactions more intense than with the second dose). At the time of the report, VACCINATION COMPLICATION (intense side effects/reactions more intense than with the second dose) outcome was unknown. Reporter informed that at pharmacy patient was given one shot but when the state showed her records the facility submitted says that patient had got a flu shot, so that raised questions for her. Patient is unsure if she got the Moderna or a flu shot. Reporter asked whether patient can get an antibody test to know if she got the booster and Is there any way she can know if she got the booster.No Concomitant medication were reported.No treatment medication were reported.This case was linked to MOD-2021-392098 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Follow up received includes no new information.
Patient was referred to report his recent Myocardial Infarction (10/03/03).  The patient reports that he last received numerous immunizations in February 2003.  He denies any known problems that occurred around the time of the immunizations but is concerned that the vaccinations may have contributed to his cardiac problems.  He was deployed 08 April 2003 and denies any chest pain, "heart burn" symptoms occurring during the deployment.  He states that he sometimes became short of breath after exercise, but this was baseline for him.  On 10/02/03, he recalls resting in his room and feeling like he had heartburn.  He "felt a strong urge to burp" but was unable to do so.  He describes the sensation as a burning feeling in the middle of his chest.  He rates it as a 6/10 on a pain scale.  He did not experience any radiation to his neck, shoulder, or down his arm.  His medical records report that he had experienced intermittent chest pain/pressure at rest x 2-3 weeks.  He denies any palpitations, diaphoresis, headache, dizziness, cough, pedal edema, shortness of breath, or nausea/vomiting.  He went to Emergency Department and after elevated cardiac enzymes, initial EKG with ST elevation in Lead III, and subsequent T wave inversion in leads II, III, and AVF, he was diagnosed with an MI.  He was later transferred to a hospital and underwent a cardiac catheterization with stent placement. Since his discharge from the hospital, he denies any further chest pain or "heartburn" type symptoms.  He has just started the process of evaluation for a medical board based on his cardiac history and degenerative joint disease/osteoarthritis.  He is scheduled for another stress test on 11/15/03.
not an adverse event, 2nd booster was given , patient received j and j as first dose (4-3-21)then pfizer as 1st booster (10-24-21) then pfizer as second booster(4-28-22). cdc guidelines state if patient received 2 boosters of j and j, then are eligible for 2nd booster for patients that are age under50 . however he received a j and j and then mrna booster so was outside of eligibility currently for the cdc guidelines as of 4-28-22 to receive 2nd booster
Ring shaped rash on his arm; This spontaneous case was reported by a patient and describes the occurrence of RASH (Ring shaped rash on his arm) in a male patient of an unknown age 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (Ring shaped rash on his arm). At the time of the report, RASH (Ring shaped rash on his arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
Information has been received from a health professional concerning a 7 year old male who on 08APR1999 was vaccinated with a dose of varicella virus vaccine live. On 12NOV2003 the patient presented with a mild case of chickenpox and there was no treatment required. There was no product quality complaint involved. Additional information has been requested.
Fever, Fatigue, Nausea/Vomiting, sore arm at injection site  Vaccine #2 just sore arm at injection site (sore x1week)
5 mins after injection pt felt shortness of breath,  throat closing, hoarse voice, tongue swelling pt given 50mg benadyl as well as 0.3mg epi pen, with reduction of throat tightness however pt continued to have sensation and occasional throat clearing/cough
Syncopal episode immediately after vaccination.  Known history of vasovagal syncope.  Seen in ED, negative work-up.  Neurology pending.  Has had flu shots annually for 23 years without incident.
Starting itching and redness/hives @ 9:00pm 11/9, woke up next morning 11/10 with a globus sensation and chest discomfort (like heart burn). Took pepcid 40mg and feeling was there all day. Went to sleep woke up 11/11 globus sensation and chest discomfort not there any more, now my hands, bilaterally,  are red, hives, burning itching. Been taking ibuprofen, pepcid, Claritin and Zyrtec barley any relief maybe 30 mins here and there
Got both shots of Moderna COVID vaccine while pregnant and is calling to enroll in pregnancy registry.; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Got both shots of Moderna COVID vaccine while pregnant and is calling to enroll in pregnancy registry.) in a 37-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic, Sulfonamide allergy, Asthma and Depression. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and SERTRALINE for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 21-Dec-2020 and the estimated date of delivery was 27-Sep-2021. On 14-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Got both shots of Moderna COVID vaccine while pregnant and is calling to enroll in pregnancy registry.). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  third week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Got both shots of Moderna COVID vaccine while pregnant and is calling to enroll in pregnancy registry.) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Pregnancy test: positive. On an unknown date, Glucose tolerance test: normal. On an unknown date, Human chorionic gonadotropin: fine. On an unknown date, Ultrasound scan: normal.         Additional tests (dates not specified) included a normal ultrasound, a glucose test and human chorionic gonadotropin reported to be "fine".
This spontaneous report as received from a registered nurse refers to an unknown number of unspecified patients. The patients' medical history was not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot #, expiration date, dose, route and site of administration were not reported). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Per Mother's report, pt awoke at 0630 and had vomited in crib, also noted to have a 102 degree Fahrenheit fever, Mother gave acetaminophen and fever dropped to 99.  PT continues to have episodes of vomiting.
DIED; This spontaneous report received from a consumer via social media via a company representative concerned a patient of unspecified age and sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry; unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. (Dose number in series 1). The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient died. On an unspecified date, from unknown cause of death. It was unspecified if an autopsy was performed. The reporter reported that "Yes, I agree. There is something in it that is causing all kinds of problems. Only one news channel gives stats. I know of someone who died from it. It is pathetic. The government want is not telling us everything. It is evil. Prayers for the United States of America. We are going at down at a fast pace." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20211263332- covid-19 vaccine ad26.cov2.s -Died. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s); Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Nocturnal seizure, pain around injection site, fatigue, chills, diarrhea
Suspected vaccination failure; Shingles; This case was reported by a consumer described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, 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 Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. Eight family members of patient received Shingrix vaccine. After receiving Shingrix vaccine, the patient experienced shingles.  This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown. This case was 1 of the 4 linked cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR063288:Same reporter US-GLAXOSMITHKLINE-US2021AMR063310:Same reporter US-GLAXOSMITHKLINE-US2021AMR063311:Same reporter
The two days after the 2nd vaccine I felt fatigue, Headache, some small muscle pains that moved quickly from one area of my body to another. Then, while I continued to be a little more tired than usual, But was able to strenuous yard work, row on my rowing machine for 45 minutes, take a 3.5 mile walk with my dog. Then about 12 days in I began to feel like I was coming down with the flu, running a little warm or easily chilled, fatigue, body aches and a persistent but fairly mild headache. I never got above 99 degrees on the thermometer and that was after taking a nap in the direct sunlight for a couple of hours on my bed. Mostly it was low, occasionally getting up to 98 but normal the rest of the time, from 96.7 to 98.6. My back hurt from the heavy yard work, and I had similar body aches that I had in the two days after Shot #2. I got a little sicker on day 2 and 3, but began to feel better on the 4th day and then feel almost 100% on the fifth day. I believe it is a substantial, if delayed response to the vaccine at about the date I would expect to achieve maximum immunity. I wasn't sure of this  when I wasn't feeling well. So about 3 and a half days of feeling sickish and then nearly fully recovered. I read that if your body has a strong immune response (which I believe this was) you might test positive for COVID if I took a test. Friends and family are urging me to get the test even though I feel pretty darn good today. I would rather wait a bit when my immune system is not in such an alarmed state and get it then to avoid a false positive. Advice?
The patient developed swelling, fluid build-up and soreness under his left arm. The soreness went away after 48 hours. The swelling lasted for approximately 5 days. The patient took Advil for the first 48 hours.
Very painful, stiff left shoulder where vaccine administered. Painful to lift arm away from body, overhead, or across chest. Painful to sleep/pull covers up.