chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administered ACTHIB vaccine that was expired to a patient with no reported adverse event; Initial information received on 02-May-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a patient of unknown age and gender who was administered HIB (PRP/T) vaccine [ACT-HIB] that was expired with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitants and family history were not provided.  On an unknown date, HIB (PRP/T) vaccine [ACT-HIB] vaccine Powder and solvent for solution for injection (batch/lot number: UJ677AAA; expiry date: 07-Apr-2023; strength, dose, route: unknown) that was expired was administered to a patient in unknown administration site for prophylactic vaccination (immunization) with no reported adverse event (expired product administered) (latency: same day)  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the 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 the 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.
the person who got the shot is dying; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received her second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient had a very bad effect from the second dose of the vaccine, it was reported that the patient who got the COVID-19 shot was dying on an unspecified date. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
In the evening I felt like I may have had bruising in my groin area I was rubbing it. The next day my leg from the calf area up had started to swell some so I was keeping it elevated. I decided that if the next day I was still having a problem I would go to the doctor. On December 10, I woke up my leg even more swollen, I went to the emergency room where they did a CT scan and found a blood clot. I was admitted. I was given enoxaparin to help break up the blood clot. I stayed in the hospital for two days, discharged with a prescription of Eliquis.
hives then returned; Hives at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of SYMPTOM RECURRENCE (hives then returned) and VACCINATION SITE URTICARIA (Hives at the injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE URTICARIA (Hives at the injection site). On 28-Jan-2021, the patient experienced SYMPTOM RECURRENCE (hives then returned). At the time of the report, SYMPTOM RECURRENCE (hives then returned) outcome was unknown and VACCINATION SITE URTICARIA (Hives at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Redness at injection site "rash per patient", she reported it to us 8/22/12.
pt recv vax 20MAR97 & on 30MAR broke out in small red raised bumps;31MAR they had blisters on them;
PATIENT COMPLAINED OF DIZZINESS (HX OF PSYCHOACTIVE MEDICATION INTAKE WIH POOR FOOD INGESTION).
about less than half of vaccine suspension was not administered-leaked out of cap to syringe; about less than half of vaccine suspension was not administered-leaked out of cap to syringe; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (about less than half of vaccine suspension was not administered-leaked out of cap to syringe) and DEVICE CONNECTION ISSUE (about less than half of vaccine suspension was not administered-leaked out of cap to syringe) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 12-Mar-2021, the patient experienced UNDERDOSE (about less than half of vaccine suspension was not administered-leaked out of cap to syringe) and DEVICE CONNECTION ISSUE (about less than half of vaccine suspension was not administered-leaked out of cap to syringe). On 12-Mar-2021, UNDERDOSE (about less than half of vaccine suspension was not administered-leaked out of cap to syringe) and DEVICE CONNECTION ISSUE (about less than half of vaccine suspension was not administered-leaked out of cap to syringe) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Erythema, warmth and induration at site of vaccine injection that then spread rapidly over a day reaching 17cm by 15cm in size (R upper arm). Painful to touch.
Small, dime sized, raised welt at injection site for Varicella (RA/SC). Welt appeared 10 days after injection.
Oral hives and anterior chest hives 45 min after injection. Spread to include periorbital edema. Self-administered famotidine, SOLU-MEDROL and BENADRYL with some relief. To ER for further evaluation. Developed shortness of breath and posterior oropharyngeal swelling. BENADRYL 50m and epinephrine administered with significant improvement. Sent home with prednisone, famotidine and EPI-PEN.
Pts arm became reddened, hard, swollen, painful. Localized reaction. Measured 5 in x 3 in.
UNSTABLE ANGINA 12/20/2022,  1/1/2023,  12/19/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
1st dose given April 11th , 2nd dose due May 9th ---- 2nd dose given too early... patient swore 2nd dose was today (May 2nd).  patient did not have vaccine card with them, technician reissued vaccine card and did not catch that it was too early.  Pharmacist did not see vaccine card so did recognize that it was too early.  Only reason it was caught was "partner" also tried to get vaccine also but pharmacist saw that card and realized that Matthew's was given too early.
Extreme Muscle sorness to the point where I felt like I couldnt move. Weakness. extreme joint stiffness. Swelling at injection site with soreness. Headache, light headed, dizziness, nausea, diarrhea, head pressure. chills, fever from 99.9 to 100.4 every few hours from about 11pm on 2/15-2/17. Last fever of 100.2 at 530pm, 2/17. swollen lymph nodes in my left armpit. still very sore and swollen at this time (2/18/21, 1148am). swollen gland in my neck on the left side, also still very sore. you can see the node by looking at my neck. I am feeling better than I was but I am still very weak and tired.
Shingles on left-side of face, on V2 dermatome.   blisters appeared on eye lid, lips, upper lip, temple area, nose
This has develpoed over time starting about 3 months after the injection. Hand tremors, SVT episodes (now on medication), insomnia, drastic change in vision.
Patient complained about arm pain that was opposite side of injection site. Increasing pain to right arm, chest pain, tingling of lips, left jaw pain.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 10-JUN-2014, the patient was vaccinated with VARIVAX lot # J007023, expiration date 05-JUN-2015. No concomitant medication reported. The reporter stated that VARIVAX was exposed to improperly stored temperatures outside the product insert. No adverse effects were reported. Causality was not reported. This case has been linked to 1406USA006736, 1406USA013598, 1406USA006998 and 1407USA000763. Additional information has been requested.
Extreme fatigue; This is a spontaneous report from a contactable consumer (Patient).   A 52-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EL92G1, Expiration Date: not reported) via an unspecified route of administration on 26Jan2021 as 2nd dose, single dose and via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported and known allergies were none. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced extreme fatigue on an unspecified date. Patient did not received any treatment for the event. The outcome of the event was recovered on an unspecified date.  Information on batch/lot number was requested.  As of 30Mar2021, lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected
Patient reported feeling heart palpitations and fatigue and anxiety Patient provided with water and seen by medical team Patient stated symptoms have resolved and refused medical transport and signed Medical form
recovery of sense of smell; recovery of sense of taste; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAROSMIA (recovery of sense of smell) and TASTE DISORDER (recovery of sense of taste) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAROSMIA (recovery of sense of smell) and TASTE DISORDER (recovery of sense of taste). At the time of the report, PAROSMIA (recovery of sense of smell) and TASTE DISORDER (recovery of sense of taste) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications or treatment information was reported.
patient collapse with subsequent EMS transport to ED, multi organ system failure, coagulation issues, required mechanical ventilation
Expired vaccine administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 75-year-old male patient who received Herpes zoster (Shingrix) (batch number 5NC4N, expiry date 08-OCT-2023) for prophylaxis.   On 07-NOV-2023, the patient received Shingrix. On 07-NOV-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: Expired vaccine administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 08-NOV-2023 The pharmacist reported that a 75 year old male patient was administered an expired dose of Shingrix which led to expired vaccine used. At the time of reporting, repeat dose had not been administered. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter. This case is linked with US2023154978, same reporter.; Sender's Comments:  US-GSK-US2023154978:Same reporter,2nd patient
Patient could not sleep at all the first night after he received vaccine. Then the next day developed low grade fever, slept all day, was pale and generally felt sick.
Nausea, light-headed, diaphoretic. Vitals wnl.
Shot administered at the acromion area of the upper shoulder. immediate pain at the injection site with little to no blood once the needle was removed. Half dollar sized purple-blue bruising within an hour of injection, dull ache in the shoulder, and soreness of the joint. By 9/11/2020 bruise turning gray, but still sore and tender to touch. Complete rotation of the shoulder possible, but with slight pain when moving the left arm up and dorsal.
soreness in the leg and thigh; inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in the leg and thigh) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: PFIZER BIONTECH COVID-19 VACCINE (LOT No. EL1283) on 11-Jan-2021 and PFIZER BIONTECH COVID-19 VACCINE (LOT No. EL9264) on 01-Feb-2021.    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced PAIN IN EXTREMITY (soreness in the leg and thigh) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered). On 03-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) had resolved. At the time of the report, PAIN IN EXTREMITY (soreness in the leg and thigh) had not resolved.            Concomitant medications were not provided.  Treatment information was not provided
3 x 4 cm sl. pink, warm, non-indurated, non tender local reaction at site of (L) deltoid symptoms onset 6/29/12; vaccine administered 6/22/12.
seizure activity (patient has h/o sz disorder is on keppra, has known R parietal AVM.
Patient received 2 doses of VARIVAX. Developed full blown chicken pox on 10/28/08.  Followed course. Did follow CP course.
10/30/15 TINGLING AND PRICKLING PAIN STARTED. 11/1/15 RASH APPEARED IN BAND LIKE SHAPES ON THE RIGHT SIDE OF BODY.
I developed shortness of breath with exertion several weeks after the Moderna vaccine around February 8th. The shortness of breath became worse  around the first week of April and I went to Non-urgent clinic on 4/4/21. Was given albuterol and recommended f/u with pulmonary specialist I also have had  left-sided chest pain started around 4/20-4/21. I went to non-urgent clinic on 4/30/21 and chest pain felt to be costochondritis. Was recommended f/u with cardiology on routine basis.. I have not diagnosis yet. I am being followed by cardiologist and pulmonologist. I am reporting these symptoms because they started about 3 weeks-1 months after my first Moderna vaccine. I do not know if the Moderna vaccine caused these symptoms I am just stating it may be a possiblity.
Took PREVENAR vaccine and broke out in rash and hives, arms sore after several days.
Ever since the vaccine was given, my menstrual cycle has had incredible breakthrough bleeding during ovulation each month since the  vaccination was administered.
12/31/22 presents to ED for "corona virus concern". PMHx of "CAD status post four-vessel CABG, numerous stents, diabetes, hypertension, and CHF"
Body ache; tiredness; chills; headache; pain at injection site; This is a spontaneous report from a contactable consumer. A 38-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 05Apr2021 at 17:00 (at the age of 38-year-old), as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Apr2021, the patient experienced body ache, tiredness, chills, headache and pain at injection site. The patient did not receive any treatment for the adverse events. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event body ache, tiredness, chills, headache, pain at injection site was not resolved.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
I got a sore throat followed by a really bad headache fever low grade a nd extreme fatigue for five days this got better but was followed low grade fever headache fatigue and many allergy like symptoms.
3 weeks after 3rd dose I noticed a decrease in sexual drive and maintaining it, and desire to not do anything as far as social events. I also had weight gain, and it all started after the 3rd dose. I called my Doctor and my Doctor scheduled me with another professional which was a therapist, and it wasn't depression or anything and they ruled that out but kept it on the tables just incase. My diet is pretty good and I have no problems with my health so I don't know why or how the weight gain started. I have another appointment with him in 3 months to prescribe something that can help with this situation. The Doctor did labs and everything was in normal range.
Patient said that she observed changes in her menstrual cycle after receiving the vaccine and also had a bad urinary tract infection shortly after receiving the vaccine; Patient said that she observed changes in her menstrual cycle after receiving the vaccine and also had a bad urinary tract infection shortly after receiving the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 46-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Manufacturer unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Manufacturer unknown), for Covid-19 Immunization. The following information was reported: URINARY TRACT INFECTION (non-serious), MENSTRUAL DISORDER (non-serious), outcome "recovered" and all described as "Patient said that she observed changes in her menstrual cycle after receiving the vaccine and also had a bad urinary tract infection shortly after receiving the vaccine". The events "patient said that she observed changes in her menstrual cycle after receiving the vaccine and also had a bad urinary tract infection shortly after receiving the vaccine" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of urinary tract infection, menstrual disorder. It was if patient had  any other vaccine in four weeks. Patient said that she observed changes in her menstrual cycle after receiving the vaccine and also had a bad urinary tract infection shortly after receiving the vaccine. AE Treatment: Not sure - she just mentioned that she went to the doctor and the emergency room. The patient did not have covid prior vaccination. It was unknown if the patient was tested for covid post vaccination. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
patient began having s/s per mother after her first dose. Began having headaches, dizziness, syncopial episodes and rapid heart rate. SHe subsequently began having panic attacks
Metallic smell in my nose; This is a spontaneous report from a contactable healthcare professional, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021 at 15:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was not allergic to medications, food, or other products. Concomitant medication included drospirenone, ethinylestradiol betadex clathrate (YAZ) from an unknown date and for unspecified indication. Prior to the vaccination, the patient was diagnosed with COVID-19 on an unknown date. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 18:15 2hours after the vaccination the patient experienced metallic smell in her nose. The patient did not receive any treatment for the reported adverse event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event metallic smell in her nose was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a registered nurse referring to unspecified number of patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant therapy were not reported. On unspecified dates, the patients were vaccinated with improperly stored ROTATEQ (lot#M038209, expiration date 23-APR-2018; lot#M040267, expiration date 14-MAY-2018;  lot#M043836, expiration date 17-JUN-2018) (dosage and route were not reported) for prophylaxis. No adverse effect was reported. The vaccine was stored at a temperature excursion of 9 Celsius to 25 Celsius for 1 hour 18 minutes and 0 Celsius to 1 Celsius for 75 hours. There was no previous temperature excursion. Data logger was involved. No product quality complaint was involved. No further information was provided. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA003595: US-009507513-1708USA008381: US-009507513-1709USA003594.
This spontaneous report as received from a physician refers to a 16 year old male patient. Approximately in April 2013 the patient was vaccinated with GARDASIL (Lot # not reported) (dose, route not reported). No other co suspects were reported. No concomitant therapy was reported. The physician reported that the patient developed a per-oral rash within 1 week of administration of GARDASIL on an unspecified date 1 month ago. The rash then spread to the patient's neck and hands. The patient was initially diagnosed with herpes by unspecified pediatrician and treated with VALTREX. The symptoms did not improve and the patient was referred for evaluation and has been prescribed an unspecified corticosteroid medication. Lab diagnostics were not performed. The outcome of the patient was initially diagnosed with herpes was reported as not recovered/not resolved. Additional information has been requested.
Patient had a generalized tonic clonic seizure lasting 2 min with post ictal 5 minutes and a second facial generalized sz in ED at 750 also lasting 2 min with no post ictal.
Started having SVT. Progressively worse after I delivered and started having more events with PVCS and Vtach.