chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a Licensed Practical Nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9 0.5 ml, subcutaneously, lot # L044475, expiration date 12-MAY-2017. There was no adverse effect reported. Product quality complain (PQC) was not involved. Administered dose of vaccine experienced the temperature excursion of 51.2 degrees Fahrenheit for 2 hours. Additional information has been requested.
The night of the flu vaccine the patient stated that she felt symptoms of what she described as a "sinus headache." The next morning she awoke with the headache and intermittent diplopia. This continued on and off for several days leading to admission on 10/14/15. MD review resulted in diagnosis of partial 6th nerve palsy with question of relation to influenza vaccine.
Site: Pain at Injection Site-Medium, Systemic: Abdominal Pain-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Cramping in stomach, in legs-Medium, Systemic: Headache-Medium, Systemic: Shakiness-Mild
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 07-APR-2015, the patient was vaccinated with a dose of oral, ROTATEQ lot # K011663 (route and dose were not reported) which was exposed to temperature outside of the recommended range during 12 hours excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
The morning after immunization patient had fever, rigors and chills. He then had progressive weakness to the point of being unable to stand resulting in him contacting EMS. In the ED was found to have SIRS physiology and lactic acidemia. Hospitalized for 2 days without clear source of infection, was not treated antibiotics and improved.
pt initially devel fever which resolved 7-10days p/vax; then devel diff walking;ultimately devel diffuse polyarthritis;pt has been managed w/NSAIDS (elavil, Naprosyn); physical therapy & splint
female who is due to get her second dose of the Pfizer BioNTech COVID-19 vaccine on Tuesday but is also scheduled to receive her allergy shots on Monday; chronic and severe headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Apr2021 16:55 (Lot number: EW0164) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Diagnosed when she was young; "Blood pressure high" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "Allergy" (unspecified if ongoing). Concomitant medication(s) included: CETIRIZINE taken for hypersensitivity; LOSARTAN taken for hypertension; SIMVASTATIN taken for blood cholesterol; FLONASE ALLERGY RELIEF; TRELEGY taken for asthma, start date: 2019; ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]. The following information was reported: HEADACHE (non-serious) with onset 20Apr2021 19:30, outcome "not recovered", described as "chronic and severe headache"; CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), outcome "unknown", described as "female who is due to get her second dose of the Pfizer BioNTech COVID-19 vaccine on Tuesday but is also scheduled to receive her allergy shots on Monday".  No follow-up attempts are possible. No further information is expected.
Twinrix administered to person under 18 years of age.  3 hours after administration, when error was caught, mother was notified. No symptoms or reactions at that time.
This spontaneous report as received from a pharmacist refers to a 65 year old female patient. The concurrent condition included diabetes mellitus, hypertension, gout and sulfa drug allergy. On an unknown date, the patient was inadvertently vaccinated with a partial dose of ZOSTAVAX (lot # L040445, Expiry: 15-JAN-2015). Concomitant therapies included EFFEXOR, ZYLOPRIM, COLCRYS, Lisinopril (manufacturer unknown), hydrochlorothiazide (manufacturer unknown), metformin, simvastatin (manufacturer unknown) and atenolol. On the same day, at unspecified time, the patient experienced slight dizziness. The outcome of dizziness was reported as resolved on the same day. No treatment was rendered for the event. No lab tests were performed. The causality was unspecified. Additional information has been requested.
COVID Vaccine Breakthrough Case Pfizer Dose 1 9/23/21 (EW0177) COVID Positive 10/6/21  10/6/21: 62-year-old lady presented to the emergency room with episode of coffee-ground emesis.  Patient reported some abdominal cramping and that was followed up with vomiting that turned to be coffee- ground.  Apparently, she had nonbloody diarrhea yesterday. She denies fever. She has a history of mitral valve replacement and does take warfarin.  The INR was noted to be greater than 9 this morning.  10/8/21: 62-year-old lady presented to the emergency room with history of hematemesis.  Patient was noted to have an INR that was 9. Coagulopathy was reversed with vitamin K and FFP, and the patient underwent EGD.  EGD reported that the patient has a gastric inflammation and a biopsy was taken.  The patient had another episode of vomiting. __________ any evidence of bleeding.  The patient feels better.  She denies cough.  She denies shortness of breath.  She is back to her baseline. Her hemoglobin has been stable.  She will be discharged home on Lovenox bridging to Coumadin until her INR is at least at 2.5.
Severe Fatigue; moderate nausea; severe headache; moderate muscle aches; mild diarrhea; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left arm, on 03Feb2021 08:30 at a single dose for COVID-19 immunization. Medical history included HTN (hypertension), depression, anxiety, RLS (Restless leg syndrome) and insomnia. Patient was not pregnant at the time of vaccination. Concomitant medication included lisinopril, trazodone, clozapine, pramipexole dihydrochloride (MIRAPEX), duloxetine hydrochloride (DULOXEE).  The patient experienced severe fatigue, moderate nausea, mild diarrhea, severe headache, moderate muscle aches on 03Feb2021 10:00 with outcome of recovering. No treatment was received. The reporter considered the events non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and has not been tested post-vaccination.  Information on the lot/batch number has been requested.
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Patient Received vaccine beyond Expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient Received vaccine beyond Expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2022 at 12:20 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 11-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient Received vaccine beyond Expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient Received vaccine beyond Expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient ethnicity reported.  The treatment information was not reported.
Patient became faint and dizzy within minutes receiving Pfizer booster vaccine.  Vital stats monitored.  Blood pressure extremely low (57/35, 74/44, 120/74), yet patient remained conscious and lucid.  O2 sat>95%. As she had not recently eaten, she was given 2 glucose tablets and some water. Mild tightness in chest, which she attributed to anxiety.  Mild sweating.  Patient consented to paramedic evaluation.  EMS activated.  Paramedics monitored vitals. Patient stabilized and recovered.  Declined ambulance transport.
she developed "a lump" around the area of the injection site "with increased tenderness and pain" around that local area as well.; she developed "a lump" around the area of the injection site "with increased tenderness and pain" around that local area as well.; Information has been received from an office nurse via a field representative referring to a 25 years old non-pregnant female patient. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was unknown.  On 01-MAY-2019, the patient was vaccinated with the third and final dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (0.5 milliliter, lot # 1602283, expiration date was auto-generated as 18-AUG-2021, strength, frequency and route were unknown) in the left arm for human papillomavirus (HPV) prevention.         On 01-MAY-2019 (reported as "within a day or two"), the patient experienced "a lump" around the area of the injection site "with increased tenderness and pain" around that local area as well. None lab diagnostics or studies were performed. The patient sought for medical attention. No overdose was reported. The outcome of the event was unknown. The causality assessment was not provided by the reporter.  This is one of two reports received from the same field representative.; Sender's Comments:  US-009507513-1905USA013057:
The day following vaccination, the patient experienced nausea/vomiting, shortness of breath, followed by extremity paresthesia, and increased heart rate. The patient went to the emergency room and was assigned an overnight admission for a potential post-vaccination adverse event. Patient was discharged the following day.
Gout flare; This spontaneous case was reported by a consumer and describes the occurrence of GOUT (Gout flare) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Gout.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced GOUT (Gout flare). At the time of the report, GOUT (Gout flare) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.  The patient had gout before going on Skyrizi. He was getting gout flare ups. He had received Covid vaccination but was anti vaccine. He would not be surprised if flare up was related to vaccine. He got vaccine in Mar-2021 and then the flare ups began. His physician wanted him to see a rheumatologist to see if he had rheumatoid arthritis.   No treatment medications were reported.  The reporter assessed the event of gout flare as possibly related to Moderna vaccine and as not reasonably possible to Humira.  Patient did not agree to have physician to be contacted.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-624353 (Patient Link).
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 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2021 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: AMLODIPINE, start date: Jan2019, stop date: 01May2022; SYNTHROID, start date: Jan2019. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", 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: (unspecified date) Positive, notes: COVID 19 Treatment; (07May2022) Negative, notes: Tested Negative Day 7. Stayed Negative Day 7, 8 and 9; (10May2022) Positive, notes: Positive again Day 10. Rebound. Therapeutic measures were taken as a result of covid-19. Clinical course: Paxlovid was given for covid 19 treatment on 01May2022 and stopped on 06May2022. Other medication was also given in 2weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Immediate itching from shot.  A 4?x4? swollen, painful red circle from injection site by time I got home <45 mins after shot. Following day couldn?t comfortably lift arm from swelling, couldn?t lay on side from pain and swelling, swollen area still 4?x4? hot and red. Also swollen lymph nodes in armpit and neck on side of injection.  Decided to write to my doctor that night about 36 hours after shot to see what I can take and if this is normal. He wanted to see me via telemedicine- this was 1/12/22. Looked at my arm and declared it an allergic reaction and worried about it turning into cellulitis.  Said it?s hard because he?s diagnosing over webcam but can see how large and inflamed it is. By 48 hours pain has subsided and itching has ramped up. He prescribed  doxycycline hyclate 100 mg/ 2 day for 7 days to be safe and start taking Benadryl or 24 hour allergy pills. I started Benadryl since it?s what I had at home. I?m instructed to call if no change by Friday.  Start the doxycycline and Benadryl regimen Wednesday night. Thursday reaction starts to fade, decrease swelling, continue itching. Friday is faintly still red, swollen and still itching.
rash & itching that started approx 3 days p/vax; most of rash subsided in 3-4 wks; itching persisted p/4 wks; rx seldane;
Within 24 hours post vax the pt developed an injection site reaction characterized by redness, warmth and swelling.
Patient received Prevnar vaccine 5/1/19.  She began experiencing symptoms the next day - redness, swelling, soreness, and warm to touch.  Symptoms did not improve despite arm elevation.  Erythema extends from shoulder to elbow.  Dr. prescribed prednisone 40mg x 5 days today (5/6/19).  Cannot give Benadryl as patient has an allergy to it.
This case was reported by a consumer and described the occurrence of vaccination failure in a male patient who received BEXSERO. Co-suspect products included BEXSERO. Concurrent medical conditions included exposure to communicable disease (total 3 students including the patient had become sick with meningococcal disease). On an unknown date, the patient received the 1st dose of BEXSERO. In October 2015, the patient received the 2nd dose of BEXSERO. In February 2016, an unknown time after receiving BEXSERO and 91 days after receiving BEXSERO, the patient experienced vaccination failure (serious criteria GSK medically significant), bacterial meningitis (serious criteria hospitalization and GSK medically significant), headache, stiff neck and fever. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the bacterial meningitis, headache, stiff neck and fever were recovered/resolved. It was unknown if the reporter considered the vaccination failure, bacterial meningitis, headache, stiff neck and fever to be related to BEXSERO and BEXSERO. Additional details were provided as follows: The patient was previously healthy and had no chronic conditions or medications. There were total 3 students (including the patient) who had become sick with meningococcal disease outbreak at the university. Approximately 3 and half months after vaccination with 2nd dose of BEXSERO, the patient experienced the events. The patient was hospitalized for 3 days and was released. There were no complications. The reporter did not know about any results of diagnostic testing on cerebrospinal fluid. This case was considered as suspected vaccination failure since the details regarding confirmatory laboratory tests were not provided.
This spontaneous report was received from a licensed practical nurse, referring to a 17 year old, female patient. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On unknown dates, the patient was vaccinated with the three dose series of GARDASIL (dose, route, lot # and expiration date were not reported). Then, on 26-JUN-2015, the patient was vaccinated with an additional dose of GARDASIL 9 by intramuscular route in the right arm (reported as RD), lot # K026247 (expiration date was not reported), because a company representative mistakenly told that it was the Centers for Disease Control and Prevention (CDC) recommendation. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information has been received.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient received BNT162b2 (BNT162B2), on 23Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) 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: "high blood pressure" (unspecified if ongoing); "Lactose intolerance" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". 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: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. COVID-19 Treatment included Paxlovid from 13Aug2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
It began with left knee pain. It was diagnosed as an arthritic flare up and was treated with cortisone successfully. That treatment is ongoing monthly. I saw a podiatrist for arthritic pain in my toe. That was also treated with cortisone.
Migraine, nausea, hot flashes, fever, high blood pressure, fatigue. Treated at ER, with benadryl, ibuprofen and something for nausea on Friday the 12th of March.
Fever, headache, fatigue- onset 12 hrs after injection Lasting 36 hours
Pt received pneumonia vaccine 10/29/18 to the (R) arm. Came to office on 10/30/18 to be evaluated. C/O redness, swelling, pain. Exam shows diffuse swelling to (R) upper arm, lateral aspect (measures 6.6 x 5 inches). Inflamed, erythematous, tender. (Portal message sent 11/4/18 to check status-no reply).
Patient and parent did not want to receive Men B.  Patient thought he was receiving  meningococcal ACWY vaccine.
got a rash on my leg / spread to my upper legs and upper body; I use CeraVe with itch relief lotion which helps me get through the day and night; This case was reported by a consumer via call center representative and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included atorvastatin calcium (Statin (Atorvastatin Calcium)) for blood cholesterol increased.   The patient's past medical history included chickenpox (in 80s) and shingles (in 80s got shingles on forehead). Previously administered products included Pravastatin Sodium (received Pravastatin Sodium approximately 13 years before reporting date).   On an unknown date, the patient received the 1st dose of Shingrix and Statin (Atorvastatin Calcium) at an unknown dose and frequency. On an unknown date, less than a year after receiving Shingrix and an unknown time after starting Zyrtec, the patient experienced rash and pruritus. The patient was treated with cetirizine hydrochloride (Zyrtec) and emollients and protectives (Cerave). On an unknown date, the outcome of the rash and pruritus were unknown.   It was unknown if the reporter considered the rash and pruritus to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient got rash on leg after vaccination so did not get the second shot. The rash spread to upper legs and upper body. The patient was using CeraVe with itch relief lotion which help to get through the day and night. The patient stated that the dermatologist felt the rash was from a statin. The patient asked for the treatment of events.
7.5 x 7.5cm area of erythema, induration, high temp of skin LLE, vastus lateralis. Follow up: chart indicates Prevnar site.  Treatment: antibiotics.
Pain at the injection site on both doses; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.      Additional details reported were as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received her first dose of Shingrix a few years ago (date unknown). On the date of her vaccination the patient felt intense pain at the injection site which did resolve in a few days. The patient referred to pain with injection on both doses although she noted the second was worse. She did not have any dates specifically though. The patient was provided medical advice disclaimer and referred to healthcare professional.  The patient was provided information per content on alternative dosing schedules. And was offered (package insert) PI. Patient would contact her pharmacy for dates of vaccination and would call back to provide the information. The consent to follow up was given. The permission to contact healthcare and pharmacy was provided. For tolerance to 2nd dose, refer case US2022046145.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022046145:Same reporter
Pt rec ZOSTAVAX 9/27/14 approx 1 PM. 9/30/14 12:20P pt presents with swelling (about 2-3" circ). It had been larger and extended to her elbow on 9/29/14 but today seems to be receding. Advised to ice and APAP. She is sensitive to many meds including antihistamines.