chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient came to pharmacy on 10/10/19 and had redness/swelling on underside of left arm. There was also heat present in the "rash". Patient denied any pain, said the swelling had actually gone down since first presenting and that he had fever throughout the night that had broken. Patient has since taken Tylenol and applied ice pack to site.
Information has been received from a nurse practitioner concerning her 6-month-old granddaughter with no pertinent medical history and no drug reactions/allergies who was vaccinated PO with the second dose of Rotateq.  There was no concomitant medication.  Subsequently, three weeks post vaccination, the patient experienced projectile vomiting and intussusception and was hospitalized.  She was hospitalized for 2 days.  On approximately 04-APR-2008, the patient developed "similar symptoms" but has not required hospitalization and has not been diagnosed with intussusception.  No additional information is available.  There was no product quality complaint.  Additional information has been requested.
pt devel high fever to 103 assoc w/excessive crying & fussiness 2 days p/vax;noted BOM
Moderate arm pain for 3 days followed by redness and a lump at the injection site. Itchiness that lasted over a week. Fever over 100 even after use of Tylenol, shaking, severe body pain, fatigue, severe pain at the injection site and up the arm to the neck, dizziness.
Information has been received from a pharmacist concerning a patient who in June 2010, was vaccinated with a dose of ZOSTAVAX (Merck) (lot number 665524/1374Y, expiration date 25-MAR-2011). The patient's relevant medical history, concomitant medications and past drug history are unknown. On an unknown date in June 2010 the consumer reported a reaction, more than the normal localized reaction which included redness, swelling and inflammation. It was unknown if there was any relevant laboratory data. As of 19-JUN-2010 it was unknown if the consumer still had redness, swelling and inflammation. It was unspecified if the patient sought medical attention. Follow-up information has been received from the pharmacist who reported that the patient experienced reactions that occurred about 24 hours post-vaccination and involved a silver dollar size rash with redness and swelling at the injection site. The patient did not receive medical attention. At the time of report, the patient 's outcome was unknown. The pharmacist commented that they vaccinated 300 patients with ZOSTAVAX (Merck) without any issues and then they had 5 patients who all had the same delayed injection site reactions which occurred the same week and from the same lot. The pharmacist did not think this was a coincidence since they had no problems with the other patients, plus each of these 5 patients were vaccinated from the same ZOSTAVAX (Merck) lot number 665524/1374Y. This is one of several reports received from the same source. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Oct2022 at 16:45 as dose 4 (booster), single (Lot number: GH9697), in left arm and on 11Aug2023 at 17:00 as dose 5 (booster), single (Lot number: GK0923) at the age of 66 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 26Feb2021 at 16:30 as dose 1, single (Lot number: EN6198), in left arm, on 18Mar2021 as dose 2, single (Lot number: ER2613), in left arm and on 18Jan2022 as dose 3 (booster), single (Lot number: FL3209), in left arm for covid-19 immunisation. The patient's relevant medical history included: "BMI>30" (unspecified if ongoing); "Known allergies: Nickel" (unspecified if ongoing). Concomitant medication(s) included: PHENTERMINE, start date: 11Aug2023, stop date: 24Aug2023; TOPIRAMATE, start date: 11Aug2023, stop date: 24Aug2023; NICOTINAMIDE, start date: 21Jul2023; CLOTRIMAZOLE, start date: 08Aug2023; FLUCONAZOLE, start date: 22Aug2023. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Never tested positive on day 6, 8, 10; symptoms decreased during 5 day treatment, but by day 6-7, started to have 2deg T surges (96.0-98.1, .2) sore throat, some nasal discharge. some coughing and sneezing.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29May2022 as dose 4 (booster), single (Lot number: fm7553) at the age of 66 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "PVC's" (unspecified if ongoing); "anxiety" (unspecified if ongoing). Known allergies: not to patient's knowledge. The medication in 2weeks product/Concomitant medication(s) included: XANAX. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Anti-viral treatment details: Product: COVID 19 treatment, Treatment start date=07Oct2022, Lot number: 2815236, Indication: Treatment of COVID-19.
erythematous swollen thick raised sores with vesicles; 2 swollen erythematous maculopapular round areas on the left side of neck; feel more inflamed; burning feeling to the touch; Is getting slightly painful; Discomfort; This is a spontaneous report from a contactable physician (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were unknown), via an unspecified route of administration on the left arm on 27Dec2020 05:30 at a single dose for COVID-19 immunization. Medical history included atopic dermatitis. Patient previously took DUPIXENT, last dose was 18Dec2020 (due to a lack of knowledge about DUPIXENT) and the COVID vaccine, patient have not taken next due dose of DUPIXANT on 01Jan2021). Patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported.  The patient previously took amoxicillin and experienced allergies. On 31Dec2020 02:00 (reported as day 4 after the injection), patient developed 2 swollen erythematous maculopapular round areas on the left side of neck that were sore and slightly have a burning sensation (not pins/needle) to the touch also described as 2 very large erythematous swollen thick raised sores with vesicles on the left side of neck. Patient showed photos to internist a couple days later when they did not go away. As of this reported, it was now day 10 and they are not bigger but they feel more inflamed and have more of a burning feeling to the touch. The small vesicle on each sore had disappeared. Patient stated she had a history of atopic dermatitis but looked and felt nothing like it. Initially had little vesicular areas in the center but the vesicles aren't there today. Discomfort remains. No associated fever or headache. Patient had read of zoster developing with COVID-19 infection, but not associated with the actual vaccine.  She was asking if this might be a weird varicella zoster reaction to the vaccine and any data about this. This did not seem to be going away and was getting slightly painful (though so far tolerable) though does not seem to be spreading at this point. Outcome of the events was not recovered. No treatment was received for the events. The reporter considered the events non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  Information on the lot/batch number has been requested.
got Gilliam Barre Syndrome from first shot; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got guillain barre syndrome after first Shingle shot, rather gave shingles.
Fever of 103 degrees Fahrenheit (39.4 degrees Celsius) for 12 hours, 102 degrees Fahrenheit (38.9 degrees Celsius) for 24 hours.; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the right arm on 30Apr2021 at 10:30 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications included levothyroxine sodium (SYNTHROID) and prenatal vitamins (RITUAL), both for unknown indications from unknown dates. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 09Apr2021 at 14:30 (at the age of 34-years-old), as single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Apr2021 at 23:00 the patient experienced fever of 103 degrees Fahrenheit (39.4 degrees Celsius) for 12 hours and 102 degrees Fahrenheit (38.9 degrees Celsius) for 24 hours and was unable to reduce the fever with Tylenol. On 30Apr2021 at 23:00, the patient underwent test for body temperature and the result was fever of 103 degrees Fahrenheit (39.4 degrees Celsius) and on 01May2021 at 11:00, the patient's body temperature was 102 degrees Fahrenheit (38.9 degrees Celsius). Therapeutic measures were taken as a result of fever and included treatment with acetaminophen (TYLENOL). The clinical outcome of the event fever was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Does not monitor freezer temperatures/Possible freezer temperature; Patient was vaccinated from vials originally stored in freezer / potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover//potential sub potent dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature) and POOR QUALITY PRODUCT ADMINISTERED (Patient was vaccinated from vials originally stored in freezer / potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover//potential sub potent dose) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 17-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was vaccinated from vials originally stored in freezer / potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover//potential sub potent dose). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature) and POOR QUALITY PRODUCT ADMINISTERED (Patient was vaccinated from vials originally stored in freezer / potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover//potential sub potent dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered POOR QUALITY PRODUCT ADMINISTERED (Patient was vaccinated from vials originally stored in freezer / potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover//potential sub potent dose) to be not related. No further causality assessment was provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature).    Concomitant medications details were not reported by the reporter. It was reported that vaccines were stored, there were no monitoring of  the freezer temperature and those vaccines were administered to patients. Vaccination site had a data logger, but it was not set up to record. The HCP stated that there were no freezer minimum and maximum temperatures to report as the temperatures were not recorded by the site. There were no adverse event, only the potential of a subtherapeutic dose due to poor freezer documentation following a freezer changeover. Treatment details were not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2022: Quality complaint number added.
Severe abdominal pain for about 4 to 5 hours, headache and fever, tired
Muscle pain at the entire body,Redness where vaccine was applied,i notice a feel red dots on my forehead,headache.
All symptoms below lasted approximately 48 hours: Pain, redness and swelling at injection site about 80mm Myalgia - significant pain at rest, which prevented normal everyday activities Fatigue  Headache  Shivering   Fever ? oral 99.3F Nausea
feeling a little ill; irritated; This is a spontaneous report from a contactable consumer (patient) from a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported, Expiry date: not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced feeling a little ill and irritated. The reporter got the first dose and she called for two concerns. First she was feeling a little ill or irritated after the first shot but now she was better. Second she was asking if she can go out and meet her family. The outcome of the events was recovering.    Follow-up attempts are completed. No further information is expected.
patient reports full body itching within 10 minutes that got progressively got worse, throat closing, tongue swelling. patient reports she was provided with Benadryl; epinephrine injections twice; and was transported to  ED. EE in ED for 4-5 hours then discharged on prednisone and Benadryl.
HEAD STARTED FEELING ITCHY ABOUT 2:50,  BY 3:45 MY THROAT STARTED TO FEEL TIGHT, BY 5:30 I WAS IN THE ER.
Patient described Arm pain that persisted for at least a week which has resolved.  However, the patient has now reported neck pain after the resolution of the arm pain.
Trouble swallowing and shakey 20 minutes after receiving vaccine, called EMS, transported to emergency department for evaluation of possible allergic reaction to vaccine. In ED, given Benadryl, ran multiple blood tests, found out my troponin was elevated indicating possible cardiac issue. Had multiple EKGs, chest CT scan. Started on aspirin and blood thinner. My troponin level continued to rise. I was directly admitted to hospital via ambulance. Spent 2 nights in hospital for cardiac monitoring. Continued to receive blood thinner and aspirin. Had multiple blood tests, echocardiogram, and cardiac catheterization procedure. Cardiac catheterization showed no blockages or clots. Diagnosed with stress cardiomyopathy congestive heart disease, which my doctor thinks the RSV vaccine may have triggered this diagnoses. Discharged after 2 nights. Prescribed  carvedilol 3.125mg twice a day, cardiac rehab 12 week program, blood pressure monitoring, and cardiology follow up in 2-3 weeks.
Mother called to report the Pt (her daughter) above developed fevers, lump in armpit (laterality not specified), muscles aches, chills, headaches. Lump has developed before in the distant past and was told by her doctor it was a lymph node and resolved on its own but lump developed within 24hrs of taking vaccine. Mother also with muscles aches, chills, headaches and fevers-much milder sxs.
Patient has experienced & is experiencing nerve pain traveling down upper arm and has difficulty lifting her right arm and has hard time to dress.
Patient was given a 2nd dose of Influenza vaccine on 1/25/22. Patient had already received this season's influenza vaccine on 9/17/21. No adverse symptoms reported at time of vaccination or to current date.
Parent called the clinic and stated that her daughter has an ovarian cyst and she believes it is from the GARDASIL 9 Vaccine.
Patient became cold and clammy, tearful, fell off exam table onto floor and hit face and head-vasovagal reaction.
She spiked a fever up to 102 with vomiting and rash on the face, upper chest and back on 2/23/04 at 4 pm.
10.10 injections administered: HAV Lot# 0019U, HBV Lot # 0723F, Influenza No preservative U2476A 10.15 c/o itching, no rash 10.20 Benadryl OTC is given by personnel 10.30 Itching continues, c/o tingling in throat, no acute distress, no trouble breathing 11.00 Admitted to ER in stable condition, recovered completely, sent back to facility in stable condition
BODY ACHES; FEVER; DIARRHEA; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced body aches, fever, and diarrhea. The action taken with covid-19 vaccine  was not applicable. The patient recovered from body aches, fever, and diarrhea. This report was non-serious.
Started spreading around arm, big rash,started separating and moving, spots were separating from each other; Like getting sick; Catching a cold; Was not feeling so great; Arm started swelling up like golf ball under arm at injection site.; Throwing up; Tired; Fever; Body aches,Extremely crashed; Had a really bad reaction; Had really bad flu like symptoms; Could not eat; Had a red spot that looked like a ring worm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had a really bad reaction), INFLUENZA LIKE ILLNESS (Had really bad flu like symptoms), FEEDING DISORDER (Could not eat), ERYTHEMA (Had a red spot that looked like a ring worm) and FEELING ABNORMAL (Was not feeling so great) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced VACCINATION COMPLICATION (Had a really bad reaction), INFLUENZA LIKE ILLNESS (Had really bad flu like symptoms), FEEDING DISORDER (Could not eat), ERYTHEMA (Had a red spot that looked like a ring worm), VACCINATION SITE SWELLING (Arm started swelling up like golf ball under arm at injection site.), VOMITING (Throwing up), FATIGUE (Tired), PYREXIA (Fever) and MYALGIA (Body aches,Extremely crashed). On 16-Mar-2021, the patient experienced FEELING ABNORMAL (Was not feeling so great), ILLNESS (Like getting sick) and NASOPHARYNGITIS (Catching a cold). On 18-Mar-2021, the patient experienced RASH (Started spreading around arm, big rash,started separating and moving, spots were separating from each other). At the time of the report, VACCINATION COMPLICATION (Had a really bad reaction), INFLUENZA LIKE ILLNESS (Had really bad flu like symptoms), FEEDING DISORDER (Could not eat), ERYTHEMA (Had a red spot that looked like a ring worm), FEELING ABNORMAL (Was not feeling so great), ILLNESS (Like getting sick), NASOPHARYNGITIS (Catching a cold), RASH (Started spreading around arm, big rash,started separating and moving, spots were separating from each other), VACCINATION SITE SWELLING (Arm started swelling up like golf ball under arm at injection site.), VOMITING (Throwing up), FATIGUE (Tired), PYREXIA (Fever) and MYALGIA (Body aches,Extremely crashed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were provided.  Patient experienced Red spot which looked like a ring worm on 13-Mar-2021 later events were stated  as circle started getting bigger on 16-Mar-2021, The circle went down on 17-Mar-2021, The circle came back with a vengeance on 18-Mar-2021 and It was like a roller coaster for two weeks on 18-Mar-2021.  Treatment was provided as cream.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow-up received and contain no other significant information.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient medical history and concurrent conditions were not reported. On 19-JAN-2016, the patient was vaccinated with incorrect stored ROTATEQ, (dose, lot number and expiry date were not reported). Concomitant therapy was not reported. It was reported that, temperature was 34F for 18 hours. There was no previous temperature excursion. No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Patient was here for his second dose of Moderna.  He initially received his first dose August 7, 2021.  Pt received Pfizer this morning, versus the Moderna.  Soldier was accepting of the situation and there was no adverse reaction.  Adverse reported per Command.  Pt knew that both vaccines were MRNA related and the efficacy would be ideal.  Pt talked to on scene.
approx 5 days post vax pt devel elevated temp, felt tired & devel a rash on inner aspect of rt forearm;
Unusual not adverse reaction. By 6:00 am the following day, knee pain reduced by about 90%. By 6:00 pm the following day rash cleared up.