chrisvoncsefalvay/vaers-outcomes huggingface dataset:
exhausted; chills; headache; shakes; felt lousy/ still feel lousy; felt awful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (felt awful), TREMOR (shakes), FEELING ABNORMAL (felt lousy/ still feel lousy), FATIGUE (exhausted) and CHILLS (chills) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced VACCINATION COMPLICATION (felt awful). On 25-Feb-2021, the patient experienced TREMOR (shakes), FEELING ABNORMAL (felt lousy/ still feel lousy), CHILLS (chills) and HEADACHE (headache). On 01-Mar-2021, the patient experienced FATIGUE (exhausted). At the time of the report, VACCINATION COMPLICATION (felt awful), TREMOR (shakes), FATIGUE (exhausted), CHILLS (chills) and HEADACHE (headache) outcome was unknown and FEELING ABNORMAL (felt lousy/ still feel lousy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications and treatment medication were reported. The reporter causality was not provided.
A non-serious spontaneous report of flu like symptoms has been received from a consumer concerning herself, a 40-year-old female, subsequent to receiving FLUMIST. No medical history or concomitant medications were reported. The patient received a single dose of FLUMIST on 23-Sep-2009. Six hours after she received FLUMIST the patient experienced flu like symptoms which included the following symptoms: shakes/chills, vomiting, headache, lack of appetite, achy and fatigue. She indicated that she did not have a fever but she does feel awful and missed a day of work. The event of flu like symptoms resolved two days later. Additional information was received on 16-Oct-2009 and incorporated into narrative: event resolved two days later.
This case was reported by a healthcare professional and described the occurrence of influenza in two to three subjects of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). The reporter did not have the specific number of subjects or demographics for these subjects. On an unspecified date the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced influenza A and vaccination failure. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified.
Information has been received from a nurse referring to a patient of unknown age and gender. Medical history of the patient was not reported. On 20-APR-2015 the patient was inadvertently vaccinated with PNEUMOVAX (lot # K004930, 0.5 ml, intramuscular) that had expired on 06-MAR-2015. No adverse effects were reported. Additional information is not expected as the reporter asked not to be contacted.
I started to feel like I had a cold coming on. I had a slight headache and was fatigued. As the day progressed, I had a mild dry cough. The symptoms were more intense the next day so I took a COVID-19 test on Wednesday and it was positive. On Thursday and Friday I developed a mild fever of 100.5 that I treated with TYLENOL. On Saturday I started PAXLOVID. The symptoms improved on Saturday and Sunday. I am still easily tired or fatigued. I am still recovering.
Information has been received from a registered nurse referring to a 16 years old patient of unknown gender. Pertinent medical history and drug reactions/allergies were not reported. On 05-FEB-2015 the patient received PROQUAD (Merck) (lot # K014798, expiration date 12-MAR-2016, therapy type, route and dose were not reported) and another dose (lot# K010209, expiration date 17-JAN-2016) on 05-MAR-2015. Concomitant drug was not reported. The patient did not experience an adverse event. This is one of two reports from the same reporter. Additional information has been requested.
AFTER 24 HOURS OF VACCINATION STAFF IS VERY LIGHTHEADED,COMPLAINED OF WEAKNESS,CLAMINESS,UNABLE TO PERFORM DAILY ACTIVITY FOR 2 DAYS AND PALPITATION.
After 1st shot had 8 days of a migraine and vertigo every day.  Then after second shot 3 weeks later, had 11 out of 12 days of migraine and after 8.5 days after shot had a whole body rash for 4.5 days .  I have had vertigo most every day since the last shot on 2/20 and have had 27 migraines since the 1st shot Jan 30th  I used Hydrocortisone on the itchy, blistery rash. Not much sleep for 3 nights.  The night before the rash popped out I experienced chest pain that I thought was heartburn but was not relieved with baking soda and water and charcoal pills.  It didn't go away until the hours into the next day and the rash was there at 3am.  I have had Migraines for many years but this is 4 times more migraines.
Pt given Flu Vaccine High Dose 65+ at 1033; pt's wife called at 1544 stating pt c/o difficulty breathing; advised ER for evaluation; spoke with pt's wife on 10/26 at 428 pm, pt recovered without tx.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose01/13/21 2nd dose02/03/21 Diagnosed covid positive:08/23/21 Symptom onset: Exposure: Symptoms:Asymptomatic
Many break outs since having the vaccine, got 2 shots/ Suspected vaccination failure; Many break outs of shingles; Hurt; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than 4 months after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Many break outs since having the vaccine, got 2 shots/ Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Many break outs of shingles) and pain (Verbatim: Hurt). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she was big vaccination advocate but he or she was truly regret on getting the shingles vaccine. The patient stated that he or she been had many break outs of shingles since having the shingles vaccine. The patient was sucked to go through the shingles. The patient reported that he or she received two doses of Shingles vaccine over the past four months and shingles hurts. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
MISSED MENSTRUAL PERIOD; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 11-MAR-2021 for prophylactic vaccination. Batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced missed menstrual period. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of missed menstrual period was not reported. This report was non-serious.
Nausea, flushing, dizziness, and syncope lasting about 15 minutes, patient was given water and an ice pack until symptoms subsided.
RASH AT INJECTION SITE, PT STATES SHE KEPT THE BANDAGE ON THE ARM FOR 4 DAYS AND NOTICED RASH.  UNSURE WHAT DATE THE RASH BEGAN BUT IT WAS REPORTED ON 10/14/2014. PT SAW DOC ON 10/14 AND DOC STATED THAT IT IS LIKELY AN ALLERGIC REACTION. DOC CALLED THE PHARMACY TO HAVE PHARMACY ENTER ALLERGY IN PATIENT PROFILE AND ASKED PHARMACY TO CONTACT VAERS.
Within two to three minutes of receiving the vaccinations, the patient was noted to have hives on his face. He was examined by Dr. who noted that the patient's lungs were clear. Treatment consisted of an injection of Benadryl (25 mg). The patient was observed for 30 minutes. There was no adverse reaction to treatment. By the end of the day, the patient was free of the hives.
This spontaneous report was received from a Registered nurse regarding a 14 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Parent brought child to a vaccine event and requested an influenza vaccination be given.  No access to system and it was identified when the record was recorded a few days later, the patient had already received the influenza vaccination.
sick for 30 days; flu like symptoms; slept for 15 hours on that day; tremendous joint pain; very lethargic; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick for 30 days), INFLUENZA LIKE ILLNESS (flu like symptoms), LETHARGY (very lethargic), SOMNOLENCE (slept for 15 hours on that day) and ARTHRALGIA (tremendous joint pain) 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 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms) and SOMNOLENCE (slept for 15 hours on that day). In February 2021, the patient experienced LETHARGY (very lethargic) and ARTHRALGIA (tremendous joint pain). On an unknown date, the patient experienced ILLNESS (sick for 30 days). At the time of the report, ILLNESS (sick for 30 days) was resolving and INFLUENZA LIKE ILLNESS (flu like symptoms), LETHARGY (very lethargic), SOMNOLENCE (slept for 15 hours on that day) and ARTHRALGIA (tremendous joint pain) outcome was unknown.            Concomitant medication and treatment information were not reported.     Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow up received on 13 may 2021 contain information  include: reporter details updated
On Christmas Day 2021 I was out shopping and started getting pain in my left calf area in my leg. It felt like a pulling sensation. I went to urgent care. Then I went to the hospital to get a DVT Scan on my left leg. The doctor said I need to get on a blood thinner. They gave me a blood thinner shot. Then I was prescribed Xarelto. The pain was subsidizing and then things were getting better so I stopped taking Xarelto because I was having a heavy menstrual cycle. One day in February 2022 I started getting out of bed one morning, and I was feeling pain in the right leg It felt like tugging in my lower right calf. I went to urgent care again. They did another DVT scan. I was sitting in urgent care for a while so I went to get something to eat. I walked a couple feet and then I started to get palpitations in my chest. I collapsed on the floor. I felt dizzy. People tried to wake me up. My head hurt because of the fall. I felt like I couldn't breathe. The ambulance was called and I was in the hospital. They told me I have blood clot in my lungs. I was told I need to get the blood clot taken out so they did the procedure. There were a lot of blood clots. They put a filter in my chest somewhere so I don't get any more blood clots in my lungs. They said it should be taken out after 6 months. I was given IV blood thinner. They checked my blood and said that Xarelto isn't the best for me so they changed my medication to Eliquis. My menstrual cycle is better and more manageable now.
This case was reported by a consumer via call center representative and described the occurrence of pain in a adult female patient who received SHINGRIX. On 3rd April 2018, the patient received the 2nd dose of SHINGRIX. On 3rd April 2018, less than a day after receiving SHINGRIX, the patient experienced pain. In April 2018, the patient experienced dizziness and feeling unwell. On an unknown date, the outcome of pain and feeling unwell were unknown and the outcome of the dizziness was not recovered/not resolved. The reporter considered the pain, dizziness and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that after her vaccination she started to experience dizziness. She stated it did not occur right away after vaccination; it might be a week later. The patient stated to feel uneasy like she might fall. The patient stated that, a day before reporting date, she did almost fall in her house. The dizziness had not gone away and she was looking for answers to stop it. The patient did not take any medication and had not made her physician aware of her experience. The name of the physician and phone number was not captured accidentally.
Inquire if pt can take the 2nd dose, had the first in 2018; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up. This case was linked with case US2021227978, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021227978:same reporter
Headache, soreness of eyes, fever, chills, mild nausea, one episode of diarrhea, fatigue, slowing of cognitive function.
This spontaneous report as received from a consumer refers to a 70 year old male patient with diabetes. Patient had no drug reactions/allergies. On 07-APR-2014 the patient was vaccinated with PNEUMOVAX 23 (single shot), subcutaneous. No concomitant medication was used. The patient stated that on 08-APR-2014 his blood sugar went up 20 points after receiving the PNEUMOVAX 23. The patient stated that his blood sugar had remained 20 points higher since 08-APR-2014. The patient did not seek medical attention and no lab diagnostics studies were performed. No treatment was given for the adverse event. The outcome of the event was reported as not recovered/not resolved. Causality assessment was not provided. Additional information has been requested.
Patient is a staff member at a LTC facility. After receiving the vaccine she stated that got very dizzy and nauseous within 5 minutes of receiving the vaccine. Stated that her head was pounding and that she was very cold. Family came and took her home. Have not heard from the family or patient since.
A physician reported that 4-5 patients "over the last 4 months" developed "severe localized reactions" following receipt of Tetanus and Diphtheria Toxoids Adsorbed, Ultrafined Lot # 4998366.  MANUFACTURERS COMMENT: The reporter was unable to specify the number of patients involved.  Additional reports will be generated when identifying information is provided.  This report was received from Medeva (Ref # MPI-2000-04566).
Redness, swelling: cellulitis on right thigh. Treated with cephalexin monohydrate suspension. Prescribed by doctor.
Three blood clots in lungs; one close to heart; Pain in lower leg that intensified and travelled up leg with swelling; Pain in lower leg that intensified and travelled up leg with swelling; This is a spontaneous report from a non-contactable consumer reported for a patient. A 57-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 02May2021 (age at vaccination was unknown) as dose 2, single for COVID-19 immunization. The patient did not have any medical history, no other medical conditions or medications. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 03Apr2021 (age at vaccination was unknown) as dose 1, single for COVID-19 immunization and had no reaction on previous exposure to vaccine. On an unspecified date in 2021, the patient experienced pain in lower leg that intensified and travelled up leg with swelling and three blood clots in lungs, one close to heart. The patient was hospitalized for the events on an unspecified date. The patient underwent lab test which included Sonogram: unknown results on an unspecified date. The caller stated that she was a Pfizer Employee calling about the COVID vaccine. Stated that she spoke with a friend about her friend's sister in law's serious reaction after the vaccine. Stated that the patient ended up with three blood clots in both of her lungs. The caller stated that she learned of these events that morning. The caller stated that a week after the second dose of the COVID vaccine the patient developed pain in her lower leg. The caller was not sure which leg. Stated that the pain intensified and started travelling up the leg with swelling in the leg. The patient went to the doctor who did a sonogram and then sent the patient to the hospital. The patient was hospitalized, dates unknown by the caller, for 3 clots in both of her lungs and one of them being close to the patient's heart. The caller stated that the patient was now under the care of a hematologist, the caller did not know the name of the hematologist. The outcome of the events was not resolved.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Swelling in throat; Feeling of tightness/closing of throat. I was able to swallow liquid but had difficulty when attempted to swallow solid food. No difficulty breathing. No other symptom presented. Throat discomfort lasted 2-3 hours.
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 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (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 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment medications were reported  No Adverse events were reported
The COVID-19 vaccine administered through vaccine administrator, Health, between June 25 and July 30 came from the lot number 039K20A.  It was discovered that this particular lot was beyond its frozen expiration date by five (5) up to forty (40) days.  A case was opened with the company (Case #: MOD21-126790).  Please refer to this case number if you would like to contact the company directly.  The company confirmed that the vaccine doses administered maintained the activity necessary to protect against the COVID-19 virus.  The company also confirmed there is no danger to anyone's health from receiving a vaccine past its frozen expiration date.  No adverse reactions were identified.
inproperly stored ROTATEQ was inadvertently administered to the one patient; no adverse effect; This spontaneous report as received from a medical assistant refers to a patient of unknown age, gender and ethnicity. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 05-NOV-2019, the patient was inadvertently vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1658256; expiration date: 18-NOV-2019; dose, frequency and route of administration were not reported) for prophylaxis. The vaccine was stored in above 9 Celsius degrees (9.4 Celsius degrees) within 20 minutes. Data logger was involved. There were no previous excursions reported. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA002785: US-009507513-1911USA002735: US-009507513-1911USA003130: US-009507513-1911USA002713:
started with itching in arm that shot was given then spread to whole body within an hour. by that night hives started breaking out all over my body. this continued for 4 weeks. I took over the counter allergy med ..zertec D in the day and benadryl at night to be able to not be so uncomfotable. dr is a dermatologist who recomended this treatment . at week 4-6 i still got hives but only here and there and especially after a hot shower