chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial consumer report received on 26 Mar 2010: This patient was vaccinated with S-OIV FLUVIRIN (batch no. unknown), 0.5 ml, intramuscular, on 19 Jan 2010. On 19 Jan 2010, the patient experienced rash that lasted until roughly on 03 Feb 2010 and the rash which was itchy, diffuse and gradually disappeared through prednisone administered (date not specified) by physician. It was determined that, the patient was allergic to thimerosal. The outcome of events were reported complete recovery on 03 Feb 2010.
C/O swelling, pain, redness and warm to (L) deltoid and patient was given BENADRYL and advised to use cool compress and take Ibuprofen.
A serious, spontaneous report of encephalopathy with non-serious events of delirium, could not sleep, sore throat, irritable and nightmares has been received from a father/consumer concerning a 45-month-old female patient subsequent to Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal vaccination. Neither concomitant medications nor medical history were reported for this patient. The patient has received influenza vaccination shot in the past. Around 09-Oct-2009, this patient received a first dose of Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal. On 06-Nov-2009, the patient received a second dose of Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal. On 08-Nov-2009, the patient experienced behavioral issues that persisted for several days. The patient could not sleep, was very irritable and experienced delirium for about a week with nightmares. The patient also experienced fever of 103 F for two weeks and vomiting for five days after fever onset. On 26-Nov-2009 the patient experienced uncontrollable drooling and was unable to swallow. The patient was taken to emergency room and diagnosed with sore throat and sent home. On 27-Nov-2009 the patient did not improve and was admitted to hospital. It was reported the patient had a feeding tube, was unable to speak and unable to walk or sit up on her own. During the hospitalization the patient had multiple MRIs and two lumbar punctures, although no results were provided. The patient remains hospitalized and the reported events were ongoing.
Fever Severe Upper Abdominal Cramps Severe Headache Body Aches (entire body) Unable to eat/drink for 36 hours
Patient was here for pfizer covid vaccine dose 1. Vaccinator administered vaccine to patient and then notified me that patient was having anxiety about needles and he placed patient on table while monitoring him for the 15 minutes as per protocol.. I went in to check on patient a few minutes later, patient was on the table, wife was present in the room. Asked patient how he was feeling, patient stated dislike and anxiety about needles. Patient was not in any distress at this time. Approximately 5 minutes later I rechecked on patient and he stated that his body felt tight. Reviewed possible cardiac signs and symptoms patient denied all but noted that his back and head felt tight, patient then stated he felt like he had to "breathe hard" . No signs of breathing difficulty at that time. Asked MD to evaluate patient. EKG was ordered, patients anxiety and pain were escalating during EKG. 911 was called. Patient care was being directed by MD while awaiting medic.pt placed on MD sechedule. See office visit note
Joints ache, chills, rash on trunk of body, several inches to the left of the injection site raised, red, painful and itchy.
Deep pain in armpit 2 days after up to present. itchy scalp, unsure when it started.  5 days after vaccine: some red skin irritation on chin and neck and groin. 6 days after vaccine: large full rashes on armpits, sides and back of neck, behind knees, groin.
This is a 63y.o. male with PMH of COPD not on home oxygen, HTN, HLD, history of DVT on Eliquis, COPD, CAD, anxiety and HFpEF who presents for recent fall and chronic ulcers on lower extremities. Patient states he fell on 01/04/22 while reaching for something while laying down. He denied feeling lightheaded at the time, head or neck injury. He complains of generalized body pain including abdomen and low back pain. He also reports pain in bilateral legs with associated left leg swelling. He has chronic leg wounds which have been dressed by wound care, unsure when last dressing change was. Unable to determine if patient lives alone or at an assisted living facility. History is limited secondary to patient's speech clarity.
The patient reported that between 24-48 hours after receiving the vaccine she developed a rash around her neck with swelling and itching.
vaccine was administered to patient after a temperature excursion of minus 1.25 degree Celsius, no AE; Initial information was received on 03-Aug-2020 regarding an unsolicited valid non-serious case from a other health professional via phone.  This case is linked to cases 2020SA203233, 2020SA202232, 2020SA202350, 2020SA203126, 2020SA202832, 2020SA203422, 2020SA203423 and 2020SA207050 (same reporter).  This case involves an four year old female patient who was vaccinated with a 0.5 ml once dose of IPV (VERO) [IPOL]  (lot P1F541M expiry date 07-Dec-2020) in the left arm on 20-Jul-2020 for prophylactic vaccination after a temperature excursion. (Product storage error)  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  No other medications of vaccinations were given on that visit.  This was an actual medication error case due to product storage error temperature too low. It was reported that, the refrigerator got too cold many times due to possible batteries issues, got to frozen temperatures several times, with a minimum of minus 1.25 degree Celsius.  No adverse event was reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
patient has severe headaches, stiff neck, insomnia, swollen face, and lazy leg
Pt recvd MMR vax & 3 wks later pt exp fever, adenopathy, & rash; no further details were provided;
This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 68-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX with an associated reaction of herpes zoster (received after age of 60 and was still getting shingles every 3 to 4 months). On an unknown date, the patient received the 1st dose of SHINGRIX. In November 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and drug dose administration interval too long. The patient was treated with acyclovir. On an unknown date, the outcome of the vaccination failure and drug dose administration interval too long were unknown and the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX and SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but it could be 67 or 68 years old. In 2018, the patient received 1st dose of SHINGRIX, but the patient could not recall the date. The patient believed that, her 2nd dose exceeded the 2 to 6 months of recommended time frame, which led to lengthening of the vaccination schedule. At the time of reporting, the patient was again experienced another breakout. The shingles breakout always occurred in the same area on her right hip. The reporter consented to follow up.
25AUG 6PM sick of stomach; 8PM t102 w/vomit; 26AUG 1130AM t104 used APAP & sponge bath; 27AUG sick of stomach, didn't eat well; temp unk; 29AUG cough w/temp;
Patient had the shots around 4pm, did not report the symptoms to his mother until the next day, but they believe they started late that same night. A rash appeared circling both armpits which also ran down the back of his arms. It felt like "a rug burn." Today his arms still have redness, but it hurts less. Mom has not used any new detergents, child was not wearing anything new. Recovering, but not completely recovered yet.
Fever, headache, baseball size knot in arm, blood infection, severe stomach pain in left side, weakness, dizziness.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 39 year old  male. The patient's height, and weight were not reported. The patient's past medical history included: kidney transplant (22 years ago at age 18), and concurrent conditions included: end-stage renal disease (ESRD), hemolytic uremic syndrome, and penicillin allergy. The patient experienced hives when treated with fexofenadine hydrochloride.  The patient received covid-19 vaccine ad26.cov2.s (Janssen series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered on 26-MAR-2021 to right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in OCT-2021, the patient underwent antibody testing and was informed that he did not had any antibodies (confirmed immunological vaccine failure). Laboratory data included: Antibody test (NR: not provided) no antibodies found. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000206157.; Sender's Comments: V0:20211219532-covid-19 vaccine ad26.cov2.s -Confirmed Immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 27 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, 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Oct2023) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient used Paxlovid from 15Oct2023 to 19Oct2023 for COVID-19 treatment. Patient reported, "I have paxlovid rebound. I tested positive for COVID 18Oct and never tested negative but my tests were very faint lines, and today they are dark lines indicating I am more infectious."  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Client had previously received one dose of Moderna primary series approximately one year prior to this vaccination. Client was given a dose of Moderna Bivalent, but had not completed primary series. Per CDC recommendations, client was vaccinated immediately with one dose of Moderna primary series.
chills until about noon today; This is a spontaneous report from a contactable consumer(Patient herself). A female patient of an unspecified age received first dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection ) via an unspecified route of administration on 18Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 19Feb2021, the patient experienced chills until about noon today. The caller was asking if she could take tylenol. The outcome of event was not recovered.    Information about lot/ batch number has been requested.
2 wk after injection, 2ndary skin inflammation ( 2"x2") with itching  below injection site which also had renewed redness
Started off with chills and fever ..then went from that to like I have the flu have cough body just aches my legs are killing me .
pt recvd vax & did not develop a titer p/8 wks;MD reported approx 14 patients;pts assigned WAES95081597 & 95081815 through 95081827
Aches and chills, fatigue, fever of 101.4 and headaches. Treated with Ibuprofen and Acetaminophen. Lasted 2 days.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 17-NOV-2015 the patient was vaccinated with an improperly stored dose of GARDASIL 9 (0.5 ml; lot # K026247, expiration date: 29-JAN-2017; dose, frequency and route unspecified). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion 5 times. The storage criteria was refrigerator (R). The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/Celsius), Celsius conversion of the lowest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 152, 30, -1.111111111 and R; 184, 29, -1.666666667 and R; 128, 33, 0.555555556 and R; 344, 31, -0.555555556 and R; 224, 32, 0 and R. This is one of several reports received from the same source. Additional information has been requested.
Soreness at injection site; This is spontaneous report received from contactable consumer (patient).  This 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number not provided), via an unknown route, on 16Feb2021 15:30 (at the age of 55-year-old) at single dose for COVID-19 immunisation, administered at Workplace clinic. No other vaccine was received in four weeks. Relevant medical history included aortic valve disease and ''carbapenem'' (as reported) allergies. Relevant concomitant medications included acetylsalicylic acid (ASPIRIN), simvastatin, metoprolol tartrate and multivitamin (unspecified). On 18Feb2021 at 07:00, the patient developed soreness at injection site. The event was reported as non-serious. Pre-vaccination and post-vaccination COVID tests were not performed. The patient was recovering from the event.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Nausea, chills/shivering, headache, body ache started on 01/11/2021
pt complained of feeling hot, sweaty and lightheaded approximately 10 minutes after vaccine administration.  pt was moved to a cool area and given the opportunity to lie down after drinking a few sips of water.  pt very quickly calmed down and stated that he was feeling better, though he was kept for a 30 minute observation.  at the end of the period, he was reassessed and found to be ok.  pt was released to the care of his mother.
This case was reported by a consumer via call center representative and described the occurrence of generalized pruritus in a 72-year-old female patient who received SHINGRIX for prophylaxis. On 21st January 2019, the patient received the 1st dose of SHINGRIX (intramuscular). In February 2019, 14 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the patient experienced generalized pruritus. The patient was treated with valaciclovir hydrochloride and BENADRYL. On an unknown date, the outcome of the generalized pruritus was recovered/resolved and the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the generalized pruritus and shingles to be related to SHINGRIX. Additional details were provided as follows: The patient experienced itching all throughout her body in areas such as arms, underneath elbows, wrist, and thighs. Most of the itching was on the left side of the body. She had also broken out with shingles twice on her tail bone. Initially she experienced Shingles was two weeks after receiving the SHINGRIX and then it cleared up. Three days before the date of reporting, shingles reappeared. The day before reporting, the patient went to her primary care physician on and she was advised to start BENADRYL for itching and valacyclovir for shingles. The reporter consented to follow up.
Patient reported redness, swelling, itchiness, hard to touch tissue, and burning in arm that vaccine was administered and for 3 days after.  She self administered Benadryl, she says that helped with the swelling and is not having any complications currently.
Case number PHEH2015US026848, is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 29 year old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501 and expiry date: May 2016) into right deltoid on 07 Oct 2015 which was stored out of recommended temperature range (temperature excursion at 34 degrees). The reporter stated that she did not known why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there were not problems since the temperature excursion. No adverse event was reported following this medication errors. Follow up information received via nurse on 26 Jan 2016: Reporter's comments updated.
Patient first displayed hives in a localized area just above the beltline. Within 6 hours, the hives spread across the patient's entire body from head to foot.  Hives were itchy, burning and painful.  Hives were evaluated by healthcare professionals and determined not to be shingles or some other known condition.  The hives have waned through several courses of treatment, but still remain present.
pt recv vax 28OCT97 & on afternoon p/vax started w/pruritic rash;seen next day w/erythema patches on entire body;urticaria;
Fever, chills within hours - lasted 2-3 days.  Severe redness/swelling near injection site right upper arm.
Information has been received from a pharmacist referring to 3 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time= 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 31-JUL-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
PATIENT EXPERIENCED SYNCOPE FOLLOWING VACCINATION WITHIN A FEW MINUTES.  PATIENT WAS ABLE TO REMAIN SEATED, ALTHOUGH HE DID APPEAR TO LOSE CONSCIOUSNESS FOR A BRIEF MOMENT. PATIENT WAS SWEATING, HAD BLURRED VISION, AND HAD A LOW PULSE. PATIENTS MOTHER SAID HE WAS ANXIOUS OVER VACCINE. PATIENT DRANK SOME WATER AND STARTED TO GET COLOR BACK AND SWEATING STOPPED. HE SAT FOR 30 MINUTES AFTER AND SAID HE FELT BETTER.
Pt arrives iwht 45 days of Short of Breath with COvid. Pt is sating 93% on RA and denies home o2. Pt was resp rate 36 with this. pt sister came to visit and brought covid. Pt denies chest pain.   Associated Symptoms: cough, shortness of breath
Mother reported child with itching over injection site on Saturday afternoon following varicella vaccine injection on Friday morning 3/25/11. Mother states fever 99.8 but no respiratory symptoms. Small dark ring over injection site - taken to ER - given BENADRYL - increased reaction over site on Sunday taken ER - given AUGMENTIN & BENADRYL.
The vaccine was stored in the refrigerator on 11-Jan-2022/Vaccine administered on 04-May-2022; The vaccine was stored in the refrigerator on 11-Jan-2022/Vaccine administered on 04-May-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vaccine was stored in the refrigerator on 11-Jan-2022/Vaccine administered on 04-May-2022) and PRODUCT STORAGE ERROR (The vaccine was stored in the refrigerator on 11-Jan-2022/Vaccine administered on 04-May-2022) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 016M20A, 001B21A and 035C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vaccine was stored in the refrigerator on 11-Jan-2022/Vaccine administered on 04-May-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was stored in the refrigerator on 11-Jan-2022/Vaccine administered on 04-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vaccine was stored in the refrigerator on 11-Jan-2022/Vaccine administered on 04-May-2022) and PRODUCT STORAGE ERROR (The vaccine was stored in the refrigerator on 11-Jan-2022/Vaccine administered on 04-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant a and treatment medications were reported.  The reporter wanted to know whether the patient need to be revaccinated or the dose was viable. The vial was initially stored in the refrigerator on 11-Jan-2022. The vial did not undergo any temperature excursions. The frequency was reported as times per. The patient had not reported adverse reaction. No medications were reported.
This spontaneous report has been received from a medical assistant and refers to an unknown number of patients of unknown ages and genders. The patients' medical histories, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. The medical assistant reported that on unknown dates, an unspecified number of patients were vaccinated with improperly stored doses of PROQUAD (lot # M036159, expiration date 12-FEB-2018; doses, routes of administration, and frequencies were not reported) for prophylaxis which were reconstituted with an sterile water diluent (manufacturer unknown) (lot numbers and expiration dates were not reported). The vaccines were exposed to a temperature excursion range from 47°F to 77°F for a total time frame of 30 minutes. There were no previous temperature excursion or data logger involved. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA009554: US-009507513-1704USA009553: