chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe itching started 6 days after vaccine with hives/welts that were small to the side of the injection site, by day 8 I had a huge 2'' by 2'', red, hot terribly itch patch at the injection site and going down, in the shape of a diamond ,  1/28/2021 it is still very itchy but did not get bigger, welts are still there.  using benadryl gel to cope.  Strange because I had no bad reaction after the shot - very little soreness, almost no bruise, I felt fine until many days later this happened!
This case was reported by a pharmacist via sales rep and described the occurrence of injection site rash in a 59-year-old female patient who received SHINGRIX. On 16th March 2018, the patient received the 1st dose of SHINGRIX. On 23rd March 2018, 7 days after receiving SHINGRIX, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was unknown. It was unknown if the reporter considered the injection site rash to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The patient experienced rash below the injection site in the morning but by the afternoon on the same day it had substantially decreased. The reporter did not feel like this was an allergic reaction or needed the physician consult. The reporter believed the adverse event had resolved, but was not sure.
This case was reported by a physician via sales rep and described the occurrence of convulsion in a 25-year-old male patient who received HAVRIX for prophylaxis. Co-suspect products included Typhoid vaccine for prophylaxis. On 10th July 2018, the patient received HAVRIX 1 ml and Typhoid vaccine .5 ml. On 21st July 2018, 11 days after receiving HAVRIX and Typhoid vaccine, the patient experienced convulsion (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the convulsion was recovered/resolved. It was unknown if the reporter considered the convulsion to be related to HAVRIX and Typhoid vaccine. Additional details were provided as follows: The patient was 25 years old at the time of reporting. The age at vaccination was not reported. However, it could be 24 or 25 years old. On 21st July 2018, the patient was admitted to hospital with convulsions the novo. The physician reported that (convulsions the novo) after various tests like spinal puncture, Magnetic resonance imaging (MRI) and there were no findings by the reporting date. The patient was well and with no other episodes of convulsions. The reporter agreed to be followed up. Lab Comments: the patient underwent spinal puncture and Nuclear magnetic resonance imagin (MRI) and there were no findings by the date of reporting.
This spontaneous report as received from a medical assistant refers to an infant patient of unknown age. No information about medical history, concurrent conditions was reported for the patient. On 04-JUN-2015 the infant patient was inadvertently administered a dose of the Adult, RECOMBIVAX HB, 10/1mcrg/ml, intramuscularly in the leg instead of the pediatric formulation. This was the first dose of the hepatitis b vaccination series this infant has been administered. No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. Additional information has been requested.
Rapid heart rate (120 bpm) as measured via smart watch. Steady and would not drop - even when at rest. Went to urgent care - blood pressure was elevated. Urgent care sent me to the ER. ER said it was dehydration and gave fluids; heart rate/blood pressure still did not drop. Followed up with primary care on 11/15/22. She prescribed Lisinopril (5 mg/1x day).  Seemed to help. At the end of January/beginning of April, began to feel lightheaded. Went to primary care on 3/2/22 to see if Lisinopril was still needed. Primary care insisted that it was still needed. Bought a home blood pressure machine - blood pressures were low. Went to cardiologist on 3/23/22. He instructed me to stop taking Lisinopril - did not think I had high blood pressure based on visit and my tracked blood pressure. After I stopped Lisinopril, no more light headedness and blood pressure returned to normal. Did a 24 hour Holter Monitor on 4/6/22 - 4/7/22 - no issues.
Anaphylactic with throat swelling , tachycardia and high BP.  Pt was given steroids, epi pen, Benadryl and observed in ICU overnight.
Received expired vaccine administered >12(US)/ hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine administered >12(US)/ hours post puncture) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Dec-2021 at 8:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine administered >12(US)/ hours post puncture). On 14-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine administered >12(US)/ hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter.  Patient received expired Moderna COVID-19 vaccine from a vial that was punctured for more than 12 hours (first punctured on 13-DEC-2021 at 2:58PM , and administered on 14-DEC-2021 at 8AM). The vial was initially stored in the refrigerator on  29-Oct-2021.The vial did not undergo any temperature excursions. The vial was stored post puncture in room  temperature. Total amount of time the vial was exposed to room temperature range (8° to 25°C 46° to 77°F) was 17.5 hours.   This case was linked to MOD-2021-414574, MOD-2021-414607, MOD-2021-414618, MOD-2021-141623 (Patient Link).
back pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 77-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious), outcome "unknown", described as "back pain". Therapeutic measures were taken as a result of back pain.  Additional information: Patient received both doses of the Pfizer-BioNTech COVID-19 Vaccine, and mentioned that it wasn't until after the vaccination that she read about ibuprofen and NSAIDs with the vaccination. Patient mentioned she had some back issues and took pain relievers (Patient doesn't have the specific date or time of taking the Advil). Patient was asking if she had "ruined her vaccination". Patient had her 1st and 2nd dose and she recently read in an article that Ibuprofen should not be taken before taking the vaccine. She did not know about this information and she had taken Ibuprofen to relieve her pain in between the vaccine doses. She would like to inquire what will happen if she had taken the Ibuprofen with her Covid vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
rash; hot sensation; redness; A spontaneous report was received from a type concerning a 78-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash, hot sensation, redness.  The patient's medical history included diabetes mellitus and cholesterol. Concomitant medications reported were Flonex, Humulin for dm, Fenofibrate, Finasteride, Losartan, Timolol for eyes, Metformin for diabetes, Tamsulosin, Atorvastatin for cholesterol for drug use for unknown indication.  On 27 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 00HN02A (Cannot be read)) intramuscularly for prophylaxis of COVID-19 infection.  On 9 Feb 2021, the patient experienced the event(s) rash. hot sensation, redness.  Treatment details included Neosporin.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), rash, hot sensation,redness was unknown.
Woke up freezing; Running high fever; Vomiting; Chills; Body aches; Headaches; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 02Mar2021 12:30 (at the age of 73-year-old) (Lot Number: Unknown) as dose number unknown, single for COVID-19 immunization. Medical history included HPB, diabetes, GERD, high cholesterol, stomach polyps. The patient had known allergies to misoprostol, spironolactone, carvedilol, ACE inhibitor, celecoxibe, pethidine (DMEEROL), furosemide (LASIX), telmisartan (MICARDIS), vioxy, hydrochlorothiazide. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN); hydralazine; omeprazole; buspirone, all taken for an unspecified indication, start and stops date were not reported. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient woke up freezing, running high fever, vomiting, chills, body aches, headaches on 03Mar2021 06:00. The patient did not receive treatment for the events. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient reports nausea, shortness of breath, and light headedness. Patient was taken to an exam room to lay down for about 20minutes. Vital signs obtained. Provider examed patient. Patient after the 20 minutes reported she felt better and was able to go home. Patient's was accompanied by her friend.
Patient vaccinated in Feb/Mar and in August 2021, developed suspected upper respiratory tract infection around 8/26/21 manifesting as headache initially progressing to cough and shortness of breath with no fever. On 8/29/21, patient noted loss of taste/smell and reached out to PCP for COVID screening. Positive PCR result from test 8/30/21 and patient reported worsening shortness of breath and cough with no fever, leading to infusion on 9/1/21 of REGEN-COV. This is reported on 9/1/21 and no future information is known at this time.
Cold chills most of the night ended in Am , slight head ache in am went away mid morning, and body aches all day the next day after.  Over the counter pain meds (ibuprophan).
Dizziness, Headache, Myalgia, Arthralgia, Fever, Chills, Fatigue, Injection site pain, Rigors, no appetite
This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. The pharmacist reported that the patient was vaccinated with the first dose of RECOMBIVAX HB on 09-DEC-2015 and the second dose of the vaccine was administered on 07-MAR-2016 (lot#, expiration date were not provided for the vaccines) (inappropriate schedule of vaccine administration). Concomitant therapies were not provided. No adverse effect was reported. Additional information has been requested.
Swelling and erythema over large area on right arm and left thigh; diagnosis cellulitis
Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Confusion-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild
Large swollen area about the size of an orange at injection site. Area is red and warm to touch. Loss of feeling/tingling in upper left arm
This case was reported by a healthcare professional and described the occurrence of lost consciousness in a 20-year-old male subject who was vaccinated with Havrix 1440 (GlaxoSmithKline).  On an unspecified date in February 2008, the subject received the 1st dose of Havrix 1440 (unknown, left arm).  Immediately after vaccination with Havrix 1440, the subject lost consciousness, then experienced a seizure.  The healthcare professional reported that the subject presented to the emergency room and was observed for a "couple of hours", but was not admitted to the hospital.  The subject had no prior history of seizures.  This case was assessed as medically serious by GSK.  At the time of reporting, the events were resolved.
I am going with I was given the first dose of SHINGRIX as my physician described it as the new shingles prevention drug to be administered in a 2-shot series. (You may want to verify with her office that this is indeed what I received). When asked if there would be any adverse effects I was told there may be some tenderness like getting punched in the arm. By 7:00 pm that evening, my arm was in extreme pain and I could not lift it beyond waste level, if that. I literally had to use my right hand to move my arm. I could not sleep that evening due to the pain. I took ibuprofen and wrapped it in a heating pad to no avail. The next day the pain persisted and I could not raise my arm to shower or even high enough to apply deodorant. I wrapped it in a compression bandage from shoulder to elbow to stabilize the movement. I called my physicians office and was advised to apply ice and double up on ZYTREC - which I did for the next 3 days. By Saturday, most of my mobility had returned but I still feel twinges of pain in the shoulder area when I lift my arm higher than mid-range.
Patient vaccinated between 10am-1 Pm on October 30, 2005. Found dead in bed next morning at home by parents. Pt had type 1 diabetes with AC1 of 7.0 but having hypoglycemic episodes  1-2 times per week and not wanting to treat the symptoms per endocrinlogist.  Term of DM removed from symtom list as per autopsy report rec'd 12/28/2005/sr This is tag-2 report.
Feeling abnormal; Headache; Chills; Her arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Her arm was sore), FEELING ABNORMAL (Feeling abnormal), HEADACHE (Headache) and CHILLS (Chills) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and High cholesterol.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced PAIN IN EXTREMITY (Her arm was sore). On 20-Feb-2021, the patient experienced HEADACHE (Headache) and CHILLS (Chills). On an unknown date, the patient experienced FEELING ABNORMAL (Feeling abnormal). The patient was treated with PARACETAMOL (TYLENOL) for Chills, at an unspecified dose and frequency. On 21-Feb-2021, CHILLS (Chills) outcome was unknown. At the time of the report, PAIN IN EXTREMITY (Her arm was sore), FEELING ABNORMAL (Feeling abnormal) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
No adverse effects; patient was  vaccinated with improperly stored MMR II; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.   On 16-FEB-2019, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot # R008031 and expiration date 18-MAR-2020 for prophylaxis (dosage schedule, route, and anatomical location were not reported). Other suspect therapy was sterile diluent for prophylaxis (dosage schedule, route, anatomical location, lot number and expiration date were not reported). The administered dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) experienced a temperature excursion above 9 degrees Celsius (8.59 C) for 15 minutes, and for sterile diluent experienced a temperature excursion above  1.18 degrees Celsius for 33 hours, as recorded by a data logger. There was no previous temperature excursion. No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA001733:
QUADRACEL (DTAP/IPV) VACCINE WAS GIVEN IN ERROR.
brain fog with it; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "not recovered", described as "brain fog with it". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Ptinr levels increased from 2.3 to 4.7; Developed Hemetoma on top of hand from levels being so high and blood too thin; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 56-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 27Jul2021 09:15 (Batch/Lot Number: EW0181) as single dose for covid-19 immunisation at the age of 56-year-old; warfarin sodium (COUMADIN) for Factor V Leiden Mutation Blood Disorder. Medical history included high cholesterol, bipolar disorder, COVID-19. Concomitant medications included aripiprazole (ABILIFY); lamotrigine (LAMICTAL); atorvastatin. On 04Aug2021 19:00, the patient experienced PT-INR levels increased from 2.3 to 4.7, danger of bleeding, developed hemetoma on top of hand from levels being so high and blood too thin. The patient underwent lab tests and procedures which included PT-INR on 04Aug2021: PT-INR levels increased from 2.3 to 4.7 in 10 days. No treatment received for the event. the event resulted in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was diagnosed with COVID-19, Since the vaccination, the patient hasn't been tested for COVID-19. The action taken in response to the event(s) for warfarin sodium was unknown. The outcome of the event was unknown. The case was reported as non-serious. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine.
allergic rxn following vax periorbital swelling & diffuse pruritis;tx w/epi & DPH;
2/11/23 I had a fever around 100, achy feeling and very tired.  I took an at home COVID test which was positive.  My doctor prescribed Paxlovid which I started taking that day.  By day three, I was feeling much better. I slept a lot.  On 2/19/23, I had a bad runny nose and sneezing. On 2/20/23, I had a low-grade temperature and tested positive for COVID. This lasted about 24 hours
Difficulty breathing, congestion, fussy, tachypnea, hypotonia, loss of milestones. The medical records state bronchitis, otitis media and sinusitis. The hospital discharge summary received on 3/30/04 states acute demyelinating encephalomyelitis (ADME).
This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a female patient who received SHINGRIX. On 10th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, less than a day after receiving SHINGRIX, the patient experienced muscle pain, tiredness, difficulty sleeping, injection site erythema, injection site itching and injection warmth. On an unknown date, the outcome of the muscle pain, tiredness, difficulty sleeping, injection site erythema, injection site itching and injection site warmth were unknown. It was unknown if the reporter considered the muscle pain, tiredness, difficulty sleeping, injection site erythema, injection site itching and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient never had allergies and problems with vaccines. The patient experienced extremely severe muscle pain that night and also felt tired and could not sleep. In April 2018, less than a week after receiving SHINGRIX, the patient had large red circle with heat and itch at the site of vaccination. The reporter asked do these reactions sound normal and will second shot have these side effects.
This spontaneous report was received from a medical assistant, concerning multiple patients of unknown ages and genders. The patients' medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD, lot #N010865, expiration date 01-OCT-2018, albumin status of recombinant human albumin (rHA) (strength, dose, frequency and route of administration were not reported) and with improperly stored doses of VARIVAX, lot #M000997, expiration date 07-JAN-2018 (strength, dose, frequency and route of administration were not reported) for prophylaxis. The vaccines were reconstituted with a properly stored sterile diluent (lot # and expiration date were not reported). The temperature excursion was reported as 15 °F to 46 °F (23.4°F) for a time frame of 2 hours and 57 minutes. Previous temperature excursion was reported as 6 °F to 14 °F (13.4 °F) for 2 hours. Digital data logger was involved to capture the temperature excursions. No product quality complaint (PQC) was involved. Follow-up information was received on 24-JUL-2018. Additional information has been requested. This is non-valid report due to lack of patient identifiers. Follow-up information was received on 24-JUL-2018 from the medical assistant who provided patient identifiers for the reported event. The patient was a 5-year-old male child who on 29-MAY-2018 was vaccinated with improperly stored dose of PROQUAD lot #N010865 with the expiration date of 01-OCT-2018. At the time of the excursion, the vaccine was deemed stable. No adverse event was reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1712USA013102: US-009507513-1808USA001953: US-009507513-1807USA012551: US-009507513-1807USA012552: US-009507513-1807USA012554: US-009507513-1807USA012555:
Flu vaccine given Wed 9/26/18 around 1:30pm. Pt states she woke up 9/28/18 around 1:30am and her arm was very itchy. She is prone to hives and when she checked her arm the area around the injection site was swollen, red and itchy. No treatment done at time. States if the itchiness worsens she will apply the medication given to her by dermatology.
Tested COVID positive on 08/12/2022 symptoms; runny nose; headache; diarrhea; abdominal pain and nausea for 48 hours. Was prescribed a course of PAXLOVID. I also have constant dizziness after I got COVID.