chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She said she got her first shot last 28Feb2021,She wants to get the second dose of Moderna; Rash on arm (injection site); Difficulty breathing; Light headedness; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing), VACCINATION SITE RASH (Rash on arm (injection site)), DIZZINESS (Light headedness) and PRODUCT DOSE OMISSION ISSUE (She said she got her first shot last 28Feb2021,She wants to get the second dose of Moderna) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Tylenol) and Drug allergy (Codeine). Concomitant products included VITAMINS NOS, APPLE CIDER VINEGAR and OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for an unknown indication.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced DYSPNOEA (Difficulty breathing), VACCINATION SITE RASH (Rash on arm (injection site)) and DIZZINESS (Light headedness). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (She said she got her first shot last 28Feb2021,She wants to get the second dose of Moderna). The patient was treated with EPINEPHRINE (intravenous) on 28-Feb-2021 for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 28-Feb-2021 for Adverse event, at an unspecified dose and frequency. On 28-Feb-2021, DYSPNOEA (Difficulty breathing), VACCINATION SITE RASH (Rash on arm (injection site)) and DIZZINESS (Light headedness) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (She said she got her first shot last 28Feb2021,She wants to get the second dose of Moderna) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient confirmed that she felt fine after taking treatment drugs. As per her doctor, she's not allergic to anything.
After 2 days of fever and aches, small rash develops on left-side of my head. Becomes painful and gets diagnosed as shingles.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with (Oka/Merck) VARIVAX  dose 1 (dose, lot # and expiry unknown). On 15-DEC-2015 the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX dose 2, from lot L015045 (dose and expiry date unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review of records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Headache, fever, extreme soreness and swelling at the injection site, general malaise.
This spontaneous report was received from a physician and healthcare worker and referring to a 5 year old female patient. The patient had no pertinent medical history, drug reactions or allergies. On 01-MAR-2011, the patient was vaccinated with one dose of VARIVAX (Merck) (dose, frequency, route of administration and indication were not reported, lot number reported as 1054Z). There were none concomitant therapies. On 28-OCT-2015 (reported as "about 2 weeks ago"), the patient developed chickenpox. The reporter stated the patient visited an unspecified emergency room, but she was uncertain whether the patient was admitted to the hospital. In 2015, the patient recovered from the chickenpox, but now has "scars all over her body" where the chickenpox lesions were. No treatment was given for the events. The outcome of scar was not reported. The physician reported that due to the length of time between receipt of VARIVAX (Merck) and the development of chickenpox, she did not feel the chickenpox could have been a vaccine-related rash and must have been caused by wild-type varicella. This is one of several reports received from the same reporter. Additional information has been requested.
I felt pain in my right arm,  after 10 minutes my right arm turned red and edematous, the area also felt hot.
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 63-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 were reported.   It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at that time. No adverse event was reported. Treatment information was not provided.
Fever 104.1 - relieved with TYLENOL but would return x 4 days. Vomiting also & diarrhea. This was reported at a later clinic - please note previous PC mother made & info provided 2 days after vacc. given. 11/11/2010 PC from Mo. to report client has 1/2 dollar size red area on (L) deltoid & has had fever on & off (highest 102 degrees). Was adv. to see HCP if increased fever or redness increased. Likely a side effect WNL.
I have Friends that got the Shingles Shot 11 of them now have shingles/ Suspected Vaccination failure; I have Friends that got the shingles shot 11 of them now have shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I have Friends that got the Shingles Shot 11 of them now have shingles/ Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I have Friends that got the shingles shot 11 of them now have shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-JUL-2023 This case was reported by a patient's friend via interactive digital media. The patient got shingles shot and now he/she had shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. This was 1 of 11 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR104624:Same Reporter US-GSK-US2023AMR104625:Same Reporter US-GSK-US2023AMR104620:Same Reporter US-GSK-US2023AMR104627:Same Reporter US-GSK-US2023AMR104628:Same Reporter US-GSK-US2023AMR104623:Same Reporter US-GSK-US2023AMR104622:Same Reporter US-GSK-US2023AMR104621:Same Reporter US-GSK-US2023AMR104626:Same Reporter US-GSK-US2023AMR104619:Same Reporter US-GSK-US2023AMR104626:same reporter US-GSK-US2023AMR104620:same reporter US-GSK-US2023AMR104622:same reporter US-GSK-US2023AMR104625:same reporter US-GSK-US2023AMR104624:same reporter US-GSK-US2023AMR104627:same reporter US-GSK-US2023AMR104621:same reporter US-GSK-US2023AMR104623:same reporter
felt "Wiped Out"/still did not feel "100% the next day / called out at work; Headache; Chills; Nausea; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 1 day after receiving Shingrix, the patient experienced fatigue, headache, chills and nausea. On an unknown date, the outcome of the fatigue, headache, chills and nausea were recovered/resolved.   The reporter considered the fatigue, headache, chills and nausea to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The age at vaccination was not reported. The patient received the first Shingrix vaccine in June 2020 in the AM. By 4 AM, the next day she had Nausea, Chills, and a Headache. The reporter stated that these symptoms seemed to be a twenty four hour thing. On the next day, patient felt wiped out. The patient was not feeling 100 percent and was called out at work. The reporter did not consent to follow up. All information was not available.
Patient admitted due to shortness of breath and hypoxia on 10/21/21. Patient was started on remdesivir and steroids as well as maintained on supplemental oxygen during his stay. Patient improved over the next few days and was discharged on 10/30/2021.
Non pruritic generalized macular-papular eruption with a few lesions with pinpoint vesicles. Some macules on palms and soles. No constitutional symptoms. Resolving at time of exam.
Pt received Engerix-B vaccination on 9-NOV-89 and on 7-DEC-89 approx one month following the second dose titers were taken & no detectable levels were reported.
This spontaneous report as received from a registered nurse refers to a 18 year old patient of unknown gender. On 25-JUN-2014 the patient was vaccinated with MMR II (therapy type: rHA, batch number: J005846, lot: 1681AA, expiry date: 17-APR-2015) that on 03/03/2014 was exposed at an unsupported temperature excursion (temperature range: 45F, time frame: 24h). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
severe flu like symptoms; muscle aches; couldn't move; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (severe flu like symptoms), MYALGIA (muscle aches) and MOVEMENT DISORDER (couldn't move) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (severe flu like symptoms), MYALGIA (muscle aches) and MOVEMENT DISORDER (couldn't move). At the time of the report, INFLUENZA LIKE ILLNESS (severe flu like symptoms), MYALGIA (muscle aches) and MOVEMENT DISORDER (couldn't move) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Heart palpitations started two days after initial dose. Since irregular heart beats didn't stop I contacted my primary spoke with MD on Tuesday February 2, 2021 for: irregular heartbeat. Feb 8, 2021 went to urgent care clinic and saw doctor at 2/8/2021 5:30 PM. 1. EKG was normal, last thyroid test was normal and less then two months old. After second dose heart palpitations were more frequent and about a month after I started having facial twitching on left side. Facial twitching is still present to this day. Facial twitching, Heart palpitations and irregular heart beats are still there.
Information has been received from a physician concerning a 16 year old male who on 03-SEP-2010 was vaccinated IM with the first dose of GARDASIL (lot# not reported). On 03-SEP-2010 the patient became dizzy and lightheaded. He fainted and fell hitting the wall, and he had cuts and broken skin on the forehead and chin and bleeding on the knee. It was reported that he was taken to the ER for bleeding and got 12 stitches on the face, and he also got a CT scan done (the result not reported). At the time of reporting, the outcomes of the events were unknown. Follow up information has been received which reported that the 16 year old male student with no pre-existing allergies who on 03-SEP-2010 at 11:45 was vaccinated IM with the first dose of GARDASIL into left arm. Concomitant therapy included FLUMIST (Lot number 501013P). 6 minutes after the vaccination, the patient experienced syncope. The patient fell and hit head, being diaphoretic. Patient returned to normal mental status within a few minutes and went to emergency room for laceration on forehead. Head computed axial tomography was negative. On an unknown date, the patient recovered. Additional information is not expected.
she had a sharp pain in her hand that went to her finger and into her wrist; unable to walk; felt like she sprained her ankle; her ankle hurt pretty bad; hands lock up and get stiff and it has gotten worse over time; she had a sharp pain in her hand that went to her finger and into her wrist; Initial information received on 23-Jan-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 65 years old female patient who had a sharp pain in her hand that went to her finger and into her wrist, unable to walk, felt like she sprained her ankle, her ankle hurt pretty bad and hands lock up and get stiff and it has gotten worse over time after receiving vaccine influenza quadrival A-B vaccine [Fluzone QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Rheumatoid arthritis.   On 31-Oct-2017, the patient received unknown dose of suspect  influenza quadrival A-B vaccine (Suspension for injection) (lot number not reported) via unknown route in unknown administration site for Prophylactic vaccination.  Twenty-four hours later "she had a sharp pain in her hand that went to her finger and into her wrist (pain in extremity)", "(pain)". Her feet were killing her, and she was not able to pick up a spoon, fork, or plate. She was even "unable to walk (gait inability)" through Walmart. She still has problems with her hands. They "lock up and get stiff and it has gotten worse over time (musculoskeletal stiffness)". Patient stated that she continues to have problems and when she was walking through the yard it felt like she "sprained her ankle (ligament sprain)" and her "ankle hurt pretty bad (arthralgia)". It only last 15-30 seconds following the administration of influenza quadrival A-B vaccine.   It was reported that "After getting the vaccine she was put on Methotrexate to take the pain away and it helps while she is on it but if she goes off, she has problems. When she does not have the methotrexate and she walked through the store if felt like she had two sprained ankles.Caller says that she was 62 at the time and had no pain or problem and now she has to have regular blood work and she is terrified to get vaccines. Caller says that she reported the issue to her healthcare provider and her rheumatoid arthritis doctor. She went to the foot doctor, and she was prescribed prednisone that caused her to have a high heart rate. Her doctor suggested in April she get blood work done and she was diagnosed with rheumatoid arthritis in July 2017. Caller says that she had to get chest x-rays, echo cardiogram and x-rays on her chest and wrist. She had to go through the trouble of getting blood work done and she is a hard stick. Caller says that she had to use Bengay and hot water because her thumbs were hurting so bad."  Action taken: not applicable.  At time of reporting, the outcome was Unknown for all the events.
pt recv vax in AM;devel a rash @ inj site;mom brought pt to ER then to PMD the next day;DPH was ordered for q 4hr;pt had ear infect, diarrhea, vomit, legs was swollen for 1wk & rash around site was resolved in 3 days;
there is clear liquid or mucus when she blows her nose and her nose is constantly running and she feels it in the back of her throat; her nose is constantly running and she feels it in the back of her throat; Tested positive for covid; Coughs up little specs of blood with dry cough; Fever; Feels a little weak at night sometimes; Light to mild cough; Losing her voice; Dry throat; Having problems breathing because of nose and throat; Loss of sense of taste and smell; Loss of sense of taste and smell; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6205; Expiration Date: 30Jun2021) via an unspecified route of administration, administered in arm left on 16Mar2021 12:30 as single dose for covid-19 immunization. The patient medical history and concomitant medications was not reported. The patient experienced Dry throat, light to mild cough, Having problems breathing because of nose and throat, loss of sense of taste and smell, Losing her voice on 26Mar2021. The patient experienced fever, feels a little weak at night sometimes on 27Mar2021. The patient was tested positive for covid on 28Mar2021. She coughs up little specs of blood with dry cough on 28Mar2021. There was clear liquid or mucus when she blows her nose and her nose was constantly running and she felt it in the back of her throat. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 28Mar2021. Therapeutic measures included Nyquil were taken as a result of fever, feels a little weak at night sometimes, dry throat, light to mild cough. The outcome of events tested positive for COVID-19 was unknown, fever was recovered with sequelae, feels a little weak at night sometimes, light to mild cough, coughs up little specs of blood with dry cough, loss of sense of taste and smell, losing her voice was recovering while dry throat, having problems breathing because of nose and throat was not recovered.  Information on Lot/Batch number was available. Additional information has been requested
No major adverse effects - mild pain at injection site for 2 days, overall mild fatigue for maybe 2 days
On 11-13-08 at 1755, I administered Pentacel in the right thigh, and Hep B and PCV into the left thigh.  In about 5 seconds, the patient's thighs became swollen and red.  At 1757 a nurse practitioner was called into the room to evaluate the child because the attending physician was unavailable.  At this time, three red flat splotches were noted on the patient's torso.  At 1805, the physician was brought into the room.  At this time the reddened areas on the thighs were present but had decreased in size.  The patient was monitored until 1830 and no other ASE were seen.
This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included COPD. On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced DYSPNEA (Shortness of breath). At the time of the report, DYSPNOEA (Shortness of breath) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was provided by the reporter as COPD medicines. Treatment information was not provided.  Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow up was received on 17-MAY-2021 included Telephone Contact Report - Event outcome updated.
Patient had a headache a couple hours after vaccine.  She discovered weakness and nausea the next day.
developed Shingles even though she was fully vaccinated with Shingrix/suspected vaccination failure; shingles; first dose 21Mar2018, second dose 25Apr2019; This serious case was reported by a other health professional via sales rep and described the occurrence of vaccination failure in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received zostavax on 10th December 2015).   On 21-MAR-2018, the patient received the 1st dose of Shingrix. On 25-APR-2019, the patient received the 2nd dose of Shingrix. On 25-APR-2019, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: first dose 21Mar2018, second dose 25Apr2019). On 27-SEP-2023, the patient experienced vaccination failure (Verbatim: developed Shingles even though she was fully vaccinated with Shingrix/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles).  The outcome of the vaccination failure and drug dose administration interval too long were unknown and the outcome of the shingles was resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 10-Oct-2023 The patient developed Shingles even though she was fully vaccinated with Shingrix.  Appears to be past the acute phase. The reporter consented to follow-up. The patient received the second dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.
Pt stated arm soreness as well as pain, redness, and inflammation at the injection site - stated she had a difficult time completing daily activities - 2 days after the shot the patient report to the local emergency room where she was treated out patient. Patient states she received a shot at the ER. Based on context clues, we believe the shot to have been a steroid shot. She was also given a short course of oral cephalexin.