chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 81-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included antihistamine for an unknown indication. On 12th November 2018, the patient received the 2nd dose of SHINGRIX 50 µg. In November 2018, the patient started antihistamine at an unknown dose and frequency. On 12th November 2018, several hours after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, injection site swelling, injection site itching and numbness of upper extremities. In November 2018, the patient experienced nausea and sleep disturbance. In November 2018, the outcome of the numbness of upper extremities was recovered/resolved. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, injection site itching and nausea were not recovered/not resolved and the outcome of the sleep disturbance was unknown. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, injection site itching, numbness of upper extremities, nausea and sleep disturbance to be related to SHINGRIX. Additional details were reported as follows: The patient had the 2nd dose of SHINGRIX on Monday (12th November 2018) afternoon and that evening she started developing pain, redness, swelling and itching at the injection site. The pain woke her up in the night. The patient arm also felt numb and she was a little nauseous. The patient saw her healthcare professional (HCP) and was told to take an antihistamine. The symptoms have gotten worse today on 16th November 2018, except for numbness, which had resolved.
Some hives and itchiness on left arm/side, treated with Benadryl Soreness and swelling on left arm/underam, treated with Naproxem
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 21-APR-2016, the patient was vaccinated with an improperly stored dose of M-M-R II (dose and route were not reported, lot # L011528, expiration date 30-APR-2017). There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 47 degrees Fahrenheit for 144 hours. There was no data logger involved. There were no previous excursion reported. This is one of the several reports received from the same source. Additional information has been requested.
Patient came into the pharmacy today with an injection site reaction. Patient's arm was swollen, red, tender to the touch, and sore which started the day after vaccination was given.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult male patient who received SHINGRIX for prophylaxis. On 4th December 2018, the patient received the 1st dose of SHINGRIX. On 4th December 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, chills, fever and fatigue. On an unknown date, the outcome of the injection site pain and fatigue were not recovered/not resolved and the outcome of the chills and fever were recovered/resolved. It was unknown if the reporter considered the injection site pain, chills, fever and fatigue to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX on left arm at 11:00 am and he experienced chills fatigue and fever the first night. The chills and fever lasted 24 hours or the first couple of nights. He also reported pain at the injection site. The injection site pain was still unresolved and was sore to the touch. The reporter did not consent to follow-up.
severe dizziness,  nausea, chest tightness,  throat feels swollen and face feels tingly
patient was underage at the time of receiving covid 19 moderna. patients parents approved for patient to get dose 2
Patient heart was visibly beating in her chest and she was clammy. Went to Hospital and was admitted to run tests. Patient does have family history of early onset heart disease.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment informations were reported.
UNABLE TO DO ANYTHING; FEVER; BODY HURTS; WOKE UP MANY TIMES IN THE NIGHT; NAUSEA; DRY MOUTH; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included had no medical history. Patient reported healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced body hurts. On 13-MAR-2021, the subject experienced woke up many times in the night. On 13-MAR-2021, the subject experienced nausea. On 13-MAR-2021, the subject experienced dry mouth. Treatment medications included: paracetamol. On 13-MAR-2021 18:00, the subject experienced fever. On 14-MAR-2021, the subject experienced unable to do anything. Treatment medications included: paracetamol. Laboratory data (dates unspecified) included: COVID-19 virus test negative (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, had not recovered from body hurts, nausea, unable to do anything, and dry mouth, and the outcome of woke up many times in the night was not reported. This report was non-serious.
woman was given 2 Fluzone High Dose vaccines in 2 months with no AE; Initial information received on 13-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 79 years old female patient who received two doses of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] prefilled syringes in 2 months (lot: not reported, expiry date: not reported), via an unknown route and site, for prophylactic vaccination (extra dose administered) on 12-Oct-2020 (second dose).  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to the extra dose administered. (latency: unknown).  Caller said her store called her today to ask her to call Pasteur to check if there is any information on giving 2 Fluzone High Dose (HD) within 2 months. Caller said the patient got a Fluzone HD at their store yesterday and then called back later that night to tell them that she had received a Fluzone HD at another clinic 2 months ago too. She is feeling fine The caller did not have any details on patient or vaccine, she said she is not at that store.  At the time of reporting, the patient had no adverse event.  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.  There will no information on the lot number for this case.
After almost a week after the second dose I am still having symptoms from the vaccine   Throwing up nausea diarrhoea fever body chills and body aches have all occurred after the vaccine this has been going on for over a week now One day going and to work coworker felt me throwing up again in the stall in advised me that I should report to the ER that I work at I have been on bed rest due to these events it was described steroids in inhaler because it is hard for me to breathe.
Chest pain that is positional and started on post vaccine day 11. Echo cardiogram is normal but EKG shows typical signs of pericarditis.
Rash on legs and arms developed 12-24 hours after vaccine administered. Lasted one day. Treated with OTC medication.; This is a spontaneous report from a contactable consumer. This consumer reported for a 40-year-old female patient (no pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730) on 23Dec2020 at single dose in left arm for covid-19 immunization. Medical history was not reported. Concomitant drug was Spironolactone in two weeks. It was reported that patient experienced Rash on legs and arms developed 12-24 hours after vaccine administered on 23Dec2020. Lasted one day with outcome was recovered. Treated with OTC medication. Patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient not been tested for COVID-19. No Allergies to medications, food, or other products.  No follow up attempts are needed. No further information is expected.
Initial misuse report received from a nurse on 01 November 2013. The 74-year-old patient had received FLUZONE ID (route, site not provided). Reporter stated that FLUZONE ID administered to 74 year old patient. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
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 59-year-old male patient received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Lot number: EN6208), in left arm and on 16Apr2021 as dose 2, single (Lot number: ER8729) at the age of 58 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 30Nov2021 as dose 3 (booster), single (Lot number: 012h21B), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient had no known allergies. the patient did not take any other medications/products within 2 weeks of starting COVID-19 treatment. Patient received brand Pfizer Anti viral product from 30Jun2022 to 04Jul2022 as COVID 19 Treatment. Patient experienced reinfection about 5 days after stopped treatment. Patient had tested negative and felt fine for a couple days then on 09Jul2022 started sneezing and got watery eyes and light congestion. It was not as bad as initial sickness. No treatment received. Patient was not recovered. Case was considered non-serious.
Pimples all over arms, legs. Splotches on face. Happened 4 days after first and second dose of Pentacel and Rotavirus. Lasts about six weeks, then clears. Some left scars.
This spontaneous report as received from a licensed practical nurse (L.P.N) refers to a 4-month-old female patient. On 21-AUG-2012 the patient was vaccinated with dose 1 of ROTATEQ (lot # not reported) orally. No concomitant medications were reported. On 31-OCT-2012 patient received dose 2 of ROTATEQ (lot # 0884AA, expiration date 14-OCT-2012) orally. No adverse experience has been observed or reported. No additional information currently available. Additional information has been requested.
Began with a cough, gradually became so debilitating that I called out of work for 3 wks, saw my doctor 3x in that time span, the last time Nov. 16, 2018. She sent me to the hospital for hypoxia. I was hospitalized for 5 days - could not return to work until 7 wks later. Addendum - beside time away from work, this hospital stay cost me over $600 secondary to my insurance. How do I get compensation for this fee?
Fever, chills, muscle ache, fatigue. Took Tylenol for the fever
improperly stored vaccine administered to patient; This spontaneous report was received from a registered nurse and refers to a 11-year-old patient of an unknown gender. The patient's pertinent medical history, concomitant medications and previous drug reactions or allergies were not reported.  On 07-OCT-2020, the patient was vaccinated with an improperly stored vaccine hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # S010729, expiration date 01-DEC-2021, 0.5 milliliter for prophylaxis (route of administration and anatomical location were not reported). The registered nurse reported that the vaccine underwent a temperature excursion of 11.3 degrees Celsius for 55 minutes. There was no previous temperature excursion. A digital data logger was involved. No product quality complaint (PQC) reported.  This is one of two reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S010729; expirationdate: 01-DEC-2021; deviceage and unit: 0 ; operatorofdevice: Unknown; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA002752:
Rapid heartbeat,  fatigue,  slight headache,  slight swelling in shot area, fever,  heaviness on chest  Took extra strength Tylenol
Fever of 101f, tired, headache, tired aching legs, inflamed/hot/hard area in the left arm where the shot was administered (don?t know which shot was in which arm, tdap was given in one arm, varicella in the other) and discoloration of skin on arm. General unwell feeling. Missed school. Still have the effects two days later.
Approximately a week after my first dose, my left arm (injection site) has swollen to the size of a softball, is extremely itchy, and my eyes have started itching very badly. My arm is very sore throughout and feels slight numbness throughout the left side of my body.
Rebound antigen-positive infection 5 days after completing the full regimen of Paxlovid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Rebound antigen-positive infection 5 days after completing the full regimen of Paxlovid) in a 70-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.  Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment. Concurrent medical conditions included Allergy. Concomitant products included BUSPIRONE and DICLOFENAC for an unknown indication. On 29-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 21-May-2022,  after starting mRNA-1273 (Spikevax), the patient experienced COVID-19 (Rebound antigen-positive infection 5 days after completing the full regimen of Paxlovid). At the time of the report, COVID-19 (Rebound antigen-positive infection 5 days after completing the full regimen of Paxlovid) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-May-2022, SARS-CoV-2 test: positive (Positive) "rebound" antigen-positive infection.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Pfizer had permission to contact patient about this report. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. Patient experienced rebound antigen-positive infection 5 days after completing the full regimen of Paxlovid. No treatment medication were reported. Paxlovid Device Date : 24May2022  Company comment: This is a spontaneous case concerning a 70-years-old male patient with no relevant medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 (Rebound antigen-positive infection 5 days after completing the full regimen of Paxlovid) which occurred 1 month 22 days after a dose of mRNA-1273vaccine(dose number not specified). SARS-CoV-2 test was positive (Positive) "rebound" antigen-positive infection as on 21-May-2022.Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement. Sender's Comments: This is a spontaneous case concerning a 70-years-old male patient with no relevant medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 (Rebound antigen-positive infection 5 days after completing the full regimen of Paxlovid) which occurred 1 month 22 days after a dose of mRNA-1273vaccine(dose number not specified). SARS-CoV-2 test was positive (Positive) "rebound" antigen-positive infection as on 21-May-2022.Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
pt recv vax 7NOV95 & on 9NOV95 2PM pt devel sl swelling & redness @ inj site;pt had no c/o SOB;pt recovered;
This spontaneous report was received from a healthcare worker refers to unspecified patients of unknown age and gender. No pertinent medical history was reported. On an unknown dates, the patients were vaccinated with VAQTA (dose, lot# were not reported) which was improperly stored. No adverse effect was reported. This is one of the several reports from the same source. Additional information has been requested.
Pt sitting for her 15 minute post vaccine period. At end of 15 minutes she was noted to become less responsive and slump in her chair. Speech not clear, could not keep eyes open. Appeared pale and clammy. Lightly retching but did not vomit. With 2 assist were able to get patient to wheechair and then to gurney nearby. BP immediately taken - it was ~ 165/80.  Pulse = 70. Pulse ox = 94%. Her color remained somewhat pale.  Pt able to talk more clear and state she is a diabetic and requests glucose check. We called a "first responder". Glucose machine arrived and her glucose was noted to be 287. She notes it has been "very up and down lately" and recently made changes in her insulin/med regimen. She states she did eat breakfast and took both her long and short acting insulin. She did eat a cracker and then after ~ 20 minutes wanted to sit up. She sat up and appeared improved but not 100%. Her BP sitting up was ~ 125/70. Pulse remained 70. She then stood up to get into wheelchair but once in wheelchair began to become less responsive again and appeared more pale. She was then put back on gurney with assist of 3 and taken to ER.  Per ER note, she did have some vomiting and dizziness. Her BP was initially 222/99. BP improved to 1178/84. She was given meclizine and rested. She felt improved and able to ambulate, and was dc'd from ER.
Patient has been experiencing lightheadedness and headaches since 12/22/2021. He received vaccine on 12/21/2021
Information has been received from a nurse concerning a 18-year-old female patient who on 15-AUG-2008 received the second dose of 0.5 mL GARDASIL (lot number, route and injection site not reported). On on 15-AUG-2008, after the vaccination the patient experienced a rash on one side of her body. She sought unspecified medical attention by calling the practice. On 15-AUG-2008 the patient recovered from the event. Additional information has been requested.
PRESENTED IN OFFICE WITH PAPULES >50 POX SOME  CRUSTED. RASH ON FACE TRUNK ARMS &LEGS. DX: VARICELLA
Pt. received vaccine then felt faint approximately 10 minutes later.  Pt was sweating profusely.  Vital signs were obtained and were normal.  Pt denied trouble breathing, chest tightening, throat closing or any itching or hives.  Pt lay down for about 10 minutes then slowly sat up.  VS taken every 5 minutes remained normal.  Pt was feeling fine and able to leave facility after 30 minutes.
This spontaneous report was received from a pharmacist via a company representative, concerning an approximately 59 year-old patient of an unknown gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were unknown by the reporter. On an unspecified date in 2015 (reported as "sometime in 2015"), the patient was vaccinated with PNEUMOVAX 23 from lot # K020215 with expiration date on 15-MAY-2016 (strength, route of administration, and anatomical location were not reported), one dose was administered for prophylaxis. On an unspecified date after vaccination, the patient began experiencing cellulitis at the injection site as well as swelling and redness at the injection site too; and it lasted approximately four days then resolved (date unspecified). The patient sought medical attention by calling to the pharmacy and was advised to apply ice to the injection site to decrease the redness and swelling but it was unknown if the patient did it. It was unknown if laboratory diagnostics studies were performed. No product quality complaint (PQC) was involved. The causal relationship between the cellulitis, swelling and redness at the injection site with PNEUMOVAX 23 was not provided. This is one of several reports received from the same source. Sender's Comments: US-009507513-1711USA007676: US-009507513-1711USA007675.
After I received the vaccine I had anaphylactic shock it look 3 rounds of EPI pens in the ER to break the reaction. I was then admitted to the hospital. Then 12 hours after injection I went into anaphylactic shock again. I was in the hospital for 23HR observation. I had bloodwork while I was admitted. I had to take to oral Benadryl for 4 days following being realized from the hospital to stop the itching.
I had the same symptoms for doses 1 (sick for 12 days) and 3 (sick for 5 days) but more mild. For the second dose, I was pretty much bed ridden for 34 days with flu like symptoms including fever, body aches, fatigue and headaches. I also had brain fog, ringing in my ears, blurry vision in my right eye, and low blood sugars which is very abnormal for me. Before the vaccine my blood sugar was never low. It is finally starting to get better now. I talked to my PCP and she just recommended that I keep an eye on things and stay hydrated. I am still experiencing some ringing in the ear as well but it is also getting better.
pt recvd vax;2 wks later swelling & redness in lt middle finger progressing to all fingers limiting mvts to approx 20%;minimal blistering; sxs persisted over 1 wk;