chrisvoncsefalvay/vaers-outcomes huggingface dataset:
has a scab where the needle was introduced/ like a pimple where the needle was introduced; headache; tiredness; fever; had "the red arm"; itchy where the needle was introduced; Possibly getting first and second dose too close; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SCAB (has a scab where the needle was introduced/ like a pimple where the needle was introduced), HEADACHE (headache), FATIGUE (tiredness), PYREXIA (fever) and VACCINATION SITE ERYTHEMA (had "the red arm") in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SCAB (has a scab where the needle was introduced/ like a pimple where the needle was introduced), HEADACHE (headache), FATIGUE (tiredness), PYREXIA (fever), VACCINATION SITE ERYTHEMA (had "the red arm"), VACCINATION SITE PRURITUS (itchy where the needle was introduced) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Possibly getting first and second dose too close). At the time of the report, VACCINATION SITE SCAB (has a scab where the needle was introduced/ like a pimple where the needle was introduced), HEADACHE (headache), FATIGUE (tiredness), PYREXIA (fever), VACCINATION SITE ERYTHEMA (had "the red arm") and VACCINATION SITE PRURITUS (itchy where the needle was introduced) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Possibly getting first and second dose too close) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  treatment medications were not reported.   Reporter did not allow further contact
side effects were Fluttering, heart palpitations, (a hyperbolic feeling) dizziness, coughing.
Information has been received from a published article, regarding a case in litigation concerning a female patient who in 2004 was vaccinated with a dose of RECOMBIVAX HB (Manufacturer unknown). Secondary suspect therapy included PNEUMOVAX 23 (Manufacturer unknown) and PEDVAXHIB (Manufacturer unknown), IPV (Manufacturer unknown) and DTAP (Manufacturer unknown). The next day the patient died of a table encephalopathy. The cause of death was encephalopathy. No further information is available.
received shingrix a year ago but not the second dose; This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received about a year ago from the date of reporting).   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 case details were reported as follows: The age at vaccination was not applicable for this report. A patient who received a Shingrix vaccine about a year ago from the date of reporting but never received the 2nd dose till the time of reporting which led to incomplete course of vaccination.  The reporter asked should they start the two regimen over again. No contact details were reported.
Employee received Hep B # 2 at 0900. Returned to office 4 hours later, complaining of severe headache, stomach pain with nausea, ringing in ears, and "warm feeling". Temp. was 100.8 deg at this time. Temp. increased in next 36 deg to 102 deg- saw her physician who felt she had an adverse effect from HBV.
Nervous system complications, severe migraine headache with disruptive micro cerebral spasms accompanied by dizziness and immediately followed by bodily nervous system spasms, repeated every few seconds and worse while standing and walking
Circular rash 1" x 1" - Itching. BP normal (144/67) at 3pm on 6/18/12).
I experienced mild nausea on 4/3/2021 and slight blood pressure drop. These are symptoms of low cortisol for me, because I have an autoimmune disease. So during a stressful body event, my body works well to keep me from fainting. The stress of the vaccine response created nausea and other cortisol symptoms, which were similar to when I had influenza years ago. I increased my dose of steroids and took Tylenol, per advice of my regular care team for my adrenal insufficiency. It was a telehealth appointment (virtual). It took about 48 hours to resolve, and then I went back to my regular dosing.
Fever 102.5, headache, chills, nausea, body aches, joint pain, fatigue, 2 days
Erythema, swelling, and pain from injection site. Erythema makes like going centrally into patient axilla.
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 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2021 01:30 PM as dose 1, single (Batch/Lot number: unknown), in left arm, in Apr2021 01:30 PM as dose 2, single (Batch/Lot number: unknown), in left arm, on 27Oct2021 at 09:30 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 03Jun2022 at 10:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Bood Pressure" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing); "Menieres Disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tylenol taken with codeine, reaction(s): "Allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: I had tested negative for 2 consecutive days; (unspecified date) Negative, notes: I had tested negative for 2 consecutive days; (unspecified date) Positive, notes: Treatment of COVID-19; (31Aug2022) Positive, notes: Tested positive again on the 8th day. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient had received Other medication in 2 weeks, which includes Celebrex, Chlorthalidone, Atorvastatin, Amlodipine, Losartan, Potassium, Vitamin D3, Vitamin B12 from unspecified dates of all medications in Aug2022 to Sep2022. It was reported that patient tested positive again on the 8th day after completing Paxlovid and had tested negative for 2 consecutive days prior to the positive test. Patient started Paxlovid as COVID 19 Treatment from 19Aug2022 to 23Aug2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
approx 5hr p/vax pt became SOB, had chills, achiness & malaise lasting until 10OCt97 when went to hosp ER approx 10AM;dx UTI;given ATB, had rxn to sulfa;
Flare up of ulcerative colitis that had been in remission for 8 years.  Also, flare up of asthma symptoms. Asthma symptoms were resolved using albuterol in a nebulizer for several days and use of inhalers (Qvar 80 and Beclomethasone). Ulcerative colitis is resolving using hydrocortisone suppositories, turmeric orally, vitamin E, and medical cannabis oil rectally. I'm also receiving three IV treatments of glutathione spread across a week to calm down my immune system.   Regardless, I still would have taken the vaccine had I known in advance. I just want others to be aware so that they are not caught by surprise, and can plan to have the necessary medications and/or their physician on call if needed.
one improperly stored dose of VARIVAX was administrated to a patient; No adverse effects reported; This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.     On 21-MAR-2019, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # N017700, expiration date 09-JUN-2019; dose, and route was unknown) for prophylaxis.    The storage temperature of the vaccine was reported as -9 to 8 degrees Celsius for a time frame of 62 hours. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. The call was due to a data logger.
1 few days p/vax pt devel an inj site rxn characterized by an area of redness & tenderness just below the inj site;pt was seen by MD dx w/an allerg rxn;
Immediately sore at site (0815). By 1:15pm -> numbness down to hand. "Numb"; "felt heavy". 10/8 - "forearm and hand feel like lifted weights", no pain at site, no redness or swelling.
p/recv vax pt began feeling cold, became quite shaky, h/a. benadryl given, O2 2 L via nasal cannula
at 2:05 PM pt reported feeling "hot". Hives and red blotches were noted on upper torso. Pt complained of chest tightness/heavyness.  Epi Pen X1 administered. Pt symptoms lessened with Epi. Pt was transported to local ER via ambulance where she  was given Epi X2
Pt called stating her arm where she got her pneumonia shot yesterday was sore, swollen and red. Pt advised to use cold compresses, Ibuprofen every 6 hours and call if it gets any worse.
No adverse effects reported; one dose of improperly stored MMR II was inadvertently administered to one patient; This spontaneous report was received from a medical assistant, referring to a 4 year old patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies were not reported. Concomitant therapies included sterile diluent used to reconstitute the vaccine, it was noted that the diluent was properly stored.  On 03-OCT-2019, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) as prophylaxis, lot number R028003 expiration date 01-OCT-2020 (strength, frequency, route of administration and anatomical injection site were not provided).  It was reported that this vaccine had been on a temperature excursion and was stored above 47 °F (52°F) during 10 hours; but it was also noted that there had not been a previous temperature excursion.  At the time of this report, there were no adverse events reported. Digital data logger was involved.
Member said she recieved the flu mist on Saturday and started feeling symptoms on Sunday.  She claims the symptoms persisted all month and then reported back to our unit on the 3rd of October.  She has been seen but we have yet to hear the results of her PCM visit.
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 71-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2022 as dose 4 (booster), single (Lot number: Fm0698) at the age of 71 years, in left arm 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: "Crohn's" (unspecified if ongoing), notes: other medical history: Crohn's. Concomitant medication(s) included: MERCAPTOPURINE, start date: 01Apr2017. Past drug history included: Cipro, reaction(s): "Allergy: Cipro", notes: known allergies: Cipro. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Negative; (27Apr2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously received a COVID-19 Vaccine. Paxlovid rebound. Tested negative at end of course of drug. 3. Days later symptoms returned, stronger than initially and with a positive antigen test.  Follow-up attempts are completed. No further information is expected.
A mistake was made while withdrawing diluent for reconstitution; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate reconstitution technique 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 inappropriate reconstitution technique. On an unknown date, the outcome of the inappropriate reconstitution technique was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as per vaccine indication. The pharmacist reported being short two vials of Shingrix diluent because a mistake was made while withdrawing diluent for reconstitution, which led to inappropriate reconstitution technique. The pharmacist did not provide lot numbers or expiration dates. The reporter consented to follow up.
8/24 afternoon- pt received vaccines evening- sent by nurse to ER with severe joint pain, nausea and lethargy.  8/25 Pt still in pain and vaccine sites swollen.
Pt recvd 3 doses of Engerix-B vax dates are not known for 1st & 2nd doses; pt recvd 3rd dose 26APR91 & 16DEC91 titers were checked & a value of 5.4 was obtained; pt showed borderline response;
Myalgia; This is a spontaneous report from a non-contactable physician (the patient).  A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, first dose on 16Dec2020 (lot EK5730) and second dose on 06Jan2021 at 18:00 (lot EL3246), both in left arm at single dose for covid-19 immunisation. The vaccine was administered at Hospital Facility. The patient did not receive other vaccine in four weeks. The patient medical history and concomitant medications were not reported. The patient experienced myalgia on 07Jan2021 08:00. The patient underwent lab tests and procedures which included Nasopharyngeal Nasal Swab/sars-cov-2 test: negative on 21Dec2020. No treatment was given for the event. The event was non-serious with outcome of recovering.   No follow-up attempts are possible. No further information is expected.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 4:39 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 4:39 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 32.03 years  Concomitant products were not provided.  On 15-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021.  On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.    Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Contracted COVID 4.5 months after vaccine. Symptoms began on 5/2/22. Tested positive on 5/3/22.  Fever, headache, fatigue, cough, sore throat for 10 days.
LOW BLOOD PRESSURE; STOMACH HURTING; DIZZINESS; LETHARGY; NOT EATING WELL; NO APPETITE; DIARRHEA; WEAK; HIGH TEMPERATURE OF 102.1; This spontaneous report received from a consumer concerned a 64 year old female. The patient's height, and weight were not reported. The patient's past medical history included: lung surgery, hernia surgery, tied tubes, and back surgery, and concurrent conditions included: peripheral artery disease, lung cancer, and seasonal allergy, and other pre-existing medical conditions included: Patient had Imder allergy. The patient experienced drug allergy when treated with clotrimazole, oxycodone hydrochloride/paracetamol, and simvastatin.  The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 31-JUL-2021, the patient experienced low blood pressure. On 31-JUL-2021, the patient experienced stomach hurting. On 31-JUL-2021, the patient experienced dizziness. On 31-JUL-2021, the patient experienced lethargy. On 31-JUL-2021, the patient experienced not eating well. On 31-JUL-2021, the patient experienced no appetite. On 31-JUL-2021, the patient experienced diarrhea. On 31-JUL-2021, the patient experienced weak. On 31-JUL-2021, the patient experienced high temperature of 102.1. Laboratory data included: Body temperature (NR: not provided) 102.1. The action taken with covid-19 vaccine was not applicable. The outcome of the diarrhea, stomach hurting, low blood pressure, high temperature of 102.1, dizziness, lethargy, not eating well, weak and no appetite was not reported. This report was non-serious. This case, involving the same patient is linked to 20210826468.
Ever since late Dec. 2021 I've felt sort of sluggish and weak. I went to visit my daughter 5 weeks ago and I really exerted myself more that I should have. They had an infection in her house but she was able to get over it quickly and have her surgery. 5 days I came to help out, I wasn't feeling very well and I developed an upper respiratory infection that started nasally and went into my bronchi. I went to the Dr. because I felt something was wrong. Dr. did a contrast CAT scan - showed bilateral lung inflammation. I was put on Z-Pak and finished last dose 3 days ago- I had to do 2 packs. I'm starting to feel better, I'm not 100%.
A few months after administration of the vaccine my daughter developed signs of autism. She started to regress by the age of 2. Diagnosed at age 7 with autism.
Headache; Arm was a little sore; Low-grade temperature; This is a spontaneous report from a contactable consumer reported for herself. A 52-years-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration in left arm on 08May2021 08:00 (Batch/Lot Number: ER8736) as a single dose for covid-19 immunisation at School or Student Health Clinic. Medical history included congestive cardiac failure, coronary artery disease, hypertension, asthma, migraines, narcolepsy, bipolar disorder, sleep apnoea, gastrooesophageal reflux disease, low potassium, low iron, tomatoes allergy, dust allergy, pollen allergy, grass allergy, ragweed allergy, allergy to medications included morphine allergy and ceclor allergy. Concomitant medications included carvedilol (COREG), clopidogrel bisulfate (PLAVIX), omega-3-acid ethyl ester (LOVAZA), bepotastine besilate (POTAS), furosemide (LASIX [FUROSEMIDE]), atorvastatin calcium and ezetimibe (STATIN EZ).The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient has not been been tested for COVID-19. The patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 05Jun2021 09:45 (Batch/Lot Number: EW0179) as a single dose for covid-19 immunisation.On 08May2021, 08:00 after administration of first dose of vaccine the patient experienced arm was a little sore, low grade temperature and headache too for some days. Clinical course was reported as on the first shot my arm was a little sore, I got a low-grade temperature and a headache too for a few days. However, with all of my allergies to medication, etc this vaccine did not bother me at all in that regard.The patient underwent lab tests and procedures which included body temperature was low. There was no treatment given for the reported events. Outcome of the events arm was a little sore, low grade temperature and headache was recovered on an unspecified date in 2021..
All of the large veins in the inside upper left arm, both pectorals, and inside upper right arm turned dark, dark blue almost black. Cleared up after 3 hours.
For about 10 minutes could not properly read or write. Upon hospitalization CTs, MRIs, and bloodwork did not show anything conclusive. Doctors diagnosed a TIA (mini stroke).
pt recv vax 24MAY97 & 23MAY97 pt exp failure to seroconvert;
Person got really pale and dizzi. Wife was with the person and the Pharmacy team tried to help the person. We offered to drink juice, put Ice pack and keep cheking him. BP was okay 112/104. Called 911. Pulse was above 100.