chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 15-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 57-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis. No Medical History information was reported. On 15-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 15-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 15-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 15-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 15-Jul-2022). No concomitant medication information was provided. The reporter administered the vaccine to the patient after the 30 day by used. Patient received half dose. The vial was initially stored in refrigerator on 04-Jun-2022. The vial did not undergo any temperature excursions. No treatment drug details was reported.
Nurse gave dose from the Moderna 6 year to 11 year old COVID vaccine vial instead of the correct vial for Moderna 6 months -5 years old. Dose given was correct at 0.25 mL. Parent has been consulted and understands.
Expired Bexsero admiistered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 21-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB39AA, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd September 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 22nd September 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-SEP-2022 Reporter's Comment: The reporter was medical assistant. The reporter reported that, they administered an expired Bexsero to a patient. The reporter called to inquire how to proceed The reporter consented to follow up. Additional Supportive Information: The reporter reported that, they administered an expired Bexsero to a patient, which led to expired vaccine used.
Received vaccine 12/29/2020.  Reports has a rash at injection site starting the week of 1/4/2021.  Red rash area, very large noted, did not have ability to measure.  Pt. states rash has gotten larger and worsened.  Pt. to be checked by provider.
fever 104.5 started 21JAN95-nausea & diarrhea; ER visit 21JAN95-given Amoxicillin ?dx; fever persistant through 25JAN95-re evaluated by pvt MD & placed on Augmentin for ?ear infect-went to ER same noc 25JAN95; dx pneumonia; hospitalized;
I woke up at 1:30 AM with severe chills, body aches, and some nausea, which was not unexpected. I took 2 ibuprofen and tried to go back to sleep. At 2:30 AM, I woke up immediately needing to vomit, but not able to get out of bed in time. I ended up vomiting over the side of my bed so forcefully that I couldn't breathe and felt like I was asphyxiating. This went on for about 5 minutes. I couldn't move off the couch for 36 hours after the first onset of symptoms. I ate saltines and drank mint tea for 48 hours.   The worst part was that I vomited so forcefully that I burst blood vessels in my eyes and all over my face. I had dark skin under my mouth and eyes for 5 days and the whites of my eyes were extremely bloody. People at work thought I was unsafe at home because of my appearance. It is now 6 days later and I still have petechiae and yellow eyes.
Flu like symptoms; Loss of taste and smell; Loss of taste and smell; Sinus pressure and discharge; Sinus pressure and discharge; This is a spontaneous report from a contactable consumer (patient). This 27-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 14May2021 at 09:00 (at the age of 27-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history was not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. The patient did not take any concomitant medications. The patient previously received dose 1 of BNT162B2 on 23Apr2021 at 09:00 for COVID-19 immunization. On 14May2021 at 19:00 the patient experienced flu-like symptoms, loss of taste and smell, and sinus pressure and discharge. The patient visited a doctor or other healthcare professional office/clinic as a result of the events. The patient received unspecified treatment for the events. The outcomes of flu-like symptoms, loss of taste and smell, and sinus pressure and discharge were unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
had shingles vaccinations and they still got it /Suspected Vaccination Failure; they still got it; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient's son or daughter. The age at vaccination was not reported. The reporter stated that, his or her father had shingles vaccination still had shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided. This case was linked with case US2021AMR176955, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR176955:same reporter
This spontaneous report was received from a medical assistant referring to a 11 year old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 06-JUN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 with lot # N002720 and expiration date 12-MAY-2019 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect or product quality complaint reported. No excursion details had been determined at the time of the report. There was a data logger involved. This is one of several reports received from the same reporter. Follow up information was received on 18-SEP-2017 from the medical assistant, concerning GARDASIL 9 with lot # N002720. On 11-MAY-2017 at 12:24, the time in the range 32°Fahrenheit (°F) to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On the same day at 21:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 8. On 12-MAY-2017 at 03:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 5. On 13-MAY-2017 at 05:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 26. On 14-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 2 hours from 16:24 to 18:24, number of cycles 21. On the same day at 20:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On 15-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 3 hours from 01:24 to 04:24, number of cycles 4. On the same day at 12:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 7. It has been determined that case # 1710USA009216 was created with the wrong Aware date as 02-OCT-2017 which is previous of the correct Aware date 18-SEP-2017. Therefore, case # 1710USA009216 is being deleted from our files and the case is consolidated into case # 1711USA003944 with the correct Aware Date 18-SEP-2017. Sender's Comments: US-009507513-1708USA011654.
Initial unsolicited case received from a health care professional (medical assistant) on 21 Aug 2017. This case involves four-year-old male patient who was vaccinated with a dose of QUADRACEL (Batch number: C5248AA, expiry date, dose, and dose in series were not reported) via intramuscular route in left thigh on 21 Aug 2017. The patient had no illness at the time of vaccination, and no pre-existing physician diagnosed allergies, birth defects, and medical conditions. Concomitant medications were not reported. On 21 Aug 2017, same day following the vaccination, the patient began crying and with his eyes feeling itchy, the patient also developed hives on his face and his eyes and lips became swollen. Benadryl (diphenhydramine hydrochloride) 10mg was given to the patient but then the patient could not swallow. MD administered an epi pen (epinephrine) and called 911, and by the time the ambulance arrived the patient was able to swallow, and he was taken to the ER. The patient relevant lab tests were unknown. Other corrective treatment was not reported. On an unknown date, the patient recovered from the event could not swallow, and the outcome of all the other events were unknown. Upon internal review the company decided to consider the case as serious due to important medical events Unable to swallow, Itchy eyes, hives broke out on his face, eyes swollen, and swollen lips. List of documents held by sender: none.; Sender's Comments: Patient experienced crying , itchy eyes, hives, eyes swollen, swollen lips, unable to swallow. Itchy eyes, hives, eyes swollen, swollen lips and unable to swallow are taken as listed under classic symptoms of anaphylactic reaction. Time to onset is compatible with the role of vaccine. Additional information including but not limited to confirmed diagnosis, the patient's immunization history (i.e., previous immunizations and any adverse events following immunization), allergic history, previous similar episodes as well as allergy testing to identify the culprit allergen are needed to further assess this case. Based on the information available, a role of the vaccine cannot be assessed.
next day i fell extreme fatigue and sweats; next day i fell extreme fatigue and sweats; 10 minutes after the shot my blood pressure went very high; my face turned beat red; This is a spontaneous report from a contactable consumer (patient) via Covid-19 Adverse Event Self-Reporting Solution.  A 51-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 19Oct2021 12:00 (Lot Number: 30135BA; expiry date: unknown) at the age of 51-years-old, as dose 1, single, for Covid-19 immunization. Medical history included fruit -anaphylaxis and Covid-19 from Nov2020 to an unknown date. The patient had no other health issues. There were no concomitant medications. The patient previously took certain antibiotics and experienced drug hypersensitivity. The patient was not tested for Covid-19 post vaccination. The vaccine was administered in the hospital. The patient did not receive other vaccines in four weeks. The patient did not receive other medications in two weeks. On 19Oct2021 at 12:10 (10 minutes after the shot), patient's blood pressure went very high, and his face turned beat red. The nurse took his pressure, and it was 167 over 101. It remained at that level only fluctuating 5 points within a time period of 1hr. They kept him onsite for monitoring. They sent him home with the same high blood pressure level. Next day, (20Oct2021) patient felt extreme fatigue and sweats. He called his doctor, and they took him in immediately. That next afternoon pressure was still at 158 over 101. They sent him to the emergency room for further blood work and tests for the heart; both with unknown results. His pressure was still the same today (21Oct2021) at 157 over 93. They told him to call cardiologist and he was waiting for an appointment. He does not have high blood pressure it's always been 120 over 80 at last. Dr physical in Jun2021 - no family history either. Patient stated that the shot caused this new health issue. Patient stated that he had Covid in Nov2020 and to this day, he had very high antibodies as he had been tested in Aug2021. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and disability or permanent damage. The events were not treated. Outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
patient felt her throat closing and she was given hydroxyzine, steriod medication and IV fluid at the ER
Information has been received on 13-JUL-2017 from a pharmacist regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 13-JUL-2017 the patient was administered a dose of VARIVAX lot # M048200 (also reported as M0048200), expiration 07-DEC-2018 subcutaneous for prophylaxis which was improperly stored. Concomitant therapies included properly stored sterile diluent (lot number and expiration unknown) which was used to reconstitute the vaccine. No adverse effects were reported. The vaccine was stored at -11 degrees Celsius for 13 full days (dates not reported.) There was no previous temperature excursion. The call was made due to a data logger. No additional information was available. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with ZOSTAVAX 19400 PFU (plaque forming units) 0.65 ml, subcutaneously, on the lower arm. No adverse effects reported. The outcome of the patient received a dose of ZOSTAVAX subcutaneously, on the lower arm was unknown. Additional information is not expected.
numbness/tingling feeling in mouth; a sore ear; numbness/tingling feeling in mouth; This is a spontaneous report from a non-contactable consumer (Patient). A 42-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6204), via an unspecified route of administration on 03Mar2021 at 08:30 as dose 1, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included estradiol (ESTRADIOL) 1 mg taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccine in four weeks and had no covid prior vaccination. On 04Mar2021 at 08:00, 24 hours after vaccine felt a sore ear and numbness/tingling feeling in mouth. None of these symptoms required medical attention but she thought with this being a new vaccine it would be helpful to report all side effects. Patient did not received treatment for event. Patient was not tested for covid post vaccination. The outcome for the events was reported as resolving.   No follow-up attempts are possible. No further information is expected.
Back, legs, arms, all muscles, and joints hurt. Called in to work. 3 PM day after vaccine pain subsided, but never stopped.  Pain level 10/10 before it subsided, subsided to 4/10. Most days pain is 5-6/10 but with medication it can be as low as 4/10. Sharp pains in legs cause falls. About 4 falls, worse in the morning. When standing after sitting for a prolonged period or in the morning getting out of bed is when pain is at it's worst.
Reactivated Covid. Tested positive for 2nd time Chills - 4 days (resolved) Fever - 8 days (resolved) Fatigue - 10 days (active) Body aches - 9 days (active) Headaches  - 4 days. (resolved)
Case number PHEH2014US015378 is an initial spontaneous report received from a medical assistant on 30 Jul 2014 with a follow up information received from the medical assistant on 03 Sep 2014. This report refers to an 11 year old male patient. Past medical history and concomitant medications was not reported. He received only Men A lyophilized conjugate component of MENVEO (batch number: M14024), reconstituted with a sterile water instead of MenCYW-135 liquid component at a dose of 0.5 ml intramuscularly in the right arm on 30 Jul 2014 at 16:09 as initial application. No adverse reaction reported following this administration error. He was recommended to have revaccination and hence he was called back to the office and administered another dose of MENVEO on an unknown date. No further information was provided. Follow up information received from the medical assistant on 03 Sep 2014: Patient demographics (height and weight), dose and site of vaccination and revaccination details updated.
Pt stated 'lips feeling numb around it", "heart's racing", "I feel itchy." Assessed pt's vitals. BP: 157/95, SpO2: 98%, HR: 104. Continued to monitor pt for an additional 15 minutes. No other symptoms noted. Denied SOB. SpO2 97-99% and HR 94-106 throughout observation. Pt stated is "sensitive." Also stated reacted to TB shot with rashes and bumps. At 1129, pt stated felt comfortable to leave facility. Instructed pt to contact provider or go to the ER if symptoms becomes severe. Pt left in stable condition. No other symptoms noted.
second dose administered on 21 days after the first shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose administered on 21 days after the first shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose administered on 21 days after the first shot). On 10-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose administered on 21 days after the first shot) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
About a week later after I received my 3rd Covid shot (booster shot), I started to feel much fatigued, stiffness and pain in my arms and legs, loss of some mobility.  By the holiday ALL  adverse events have increased.  Made an appointment with primary Dr. Appt Dec 15, 2021.  By then I was in EXTREME pain  and immobile.  By holiday and January I was not able to even lift myself .  I was EXTREME-DEBILITATED.
pt recvd vax in AM; pt noted to be listless in later afternoon; listless inc sleep & difficult to arouse on 8FEB95;
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 08-AUG-2016, the patient was vaccinated with an improperly stored dose of VARIVAX injection (lot# L045953; dose, route of administration and expiry date were not reported). There were no concomitant therapies reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
On May 29, 1999 the pt experienced chickenpox with approximately 75-100 lesions. The reporting physician noted heavy exposure at day care.
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 34-year-old male patient received BNT162b2 (BNT162B2), on 07Dec2021 as dose 3 (booster), single (Lot number: 330308D) at the age of 34 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset May2022, outcome "unknown", COVID-19 (medically significant) with onset May2022, outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive, notes: Symptoms came back about two weeks after last dose of paxlovid. Nothing major just runny nose and I decided to take a rapid test and it came up positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received vaccine. Patient did not received other medication in 2 weeks. Patient received treatment with paxlovid from 25Apr2022 to 30Apr2022.
Right Thigh Abscess.  Developed redness and induration that progressed, currently being treated.
(4/8-4/10) Days 1-3: normal side effects - arm pain, headache, fever, body aches. (4/11-4/13) Days 4-6: fever, body aches, headache. (4/14-4/20) Days 7-13: still ongoing fever, new cough and weakness, loss of appetite, nausea and mild vomiting.
I woke up on Wednesday, and felt slight pressure, a little sharpness. Eventually, the pressure and pain was too much, I went to the ER.  I coudnt drive myself, as I was dizzy I eventually self-diagnosed pericarditius When I got there at 9pm,  tachycardia of over 160.