chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles; body is shutting down; This is a spontaneous report from a contactable consumer.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) for COVID-19 immunisation and has had hives ever since. They have put her on steroids and that didn't help. They told her she had shingles, but the patient's parents don't believe it was shingles. She has had hives since she got the first shot and then they give her the second shot and that is when they thought it was shingles. The reported also stated, "the doctors don't know how to help her. They keep passing her off. No one is helping her. Her body is shutting down. She is not anaphylactic but can it turn anaphylactic. I need to know what Pfizer wants us to treat her with. You have to know how to treat your side effects. No one cares. I can't get her into the allergist office. All you care about is distributing these vaccines but you don't care anything about what is happening to the people taking them". The outcome of the events was unknown.   No follow-up attempts are completed; information about lot/batch number cannot be obtained.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 26-JUN-2015, the patient was vaccinated with an improperly stored dose of VAQTA 50 U/ 1 ml (lot # K006604, expiration date 21-OCT-2015). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/ Celsius) and the type of excursion (R/F) for each time were 144, 31 and R; 240, 34 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
This patient was seen to have a classic Varicella compatible with history of onset 4 days ago; seen with hands red of lesions on the 4th day of illness 05/07/01, no new lesions then but expected.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 05-JUL-2016, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 05-JAN-2017, the patient was treated by a nurse practitioner for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is considered to be not recovered. Additional information has been requested.
has a cold; This case was reported by a consumer via patient support programs and described the occurrence of cold in a 89-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2021-2022 season) for prophylaxis.   The patient's past medical history included renal stone (had kidney stones from an unknown date in August 2021 till September 2021) and hospitalization (was in hospital for Kidney stones from an unknown date in August 2021 to September 2021). Previously administered products included CEFUROXIME AXETIL (received Cefuroxime Axetil 500 mg (Antibiotic) from an unknown date in August 2021 to September 2021). Concurrent medical conditions included chronic obstructive pulmonary disease. Concomitant products included fluticasone furoate + umeclidinium bromide + vilanterol trifenatate (Trelegy Ellipta) and proair (nos) (Pro-Air).   In October 2021, the patient received Influenza vaccine Quadrivalent 2021-2022 season. On an unknown date, less than 2 weeks after receiving Influenza vaccine Quadrivalent 2021-2022 season and an unknown time after starting Trelegy Ellipta, the patient experienced cold. The patient was treated with cefuroxime axetil. On an unknown date, the outcome of the cold was not recovered/not resolved.   It was unknown if the reporter considered the cold to be related to Influenza vaccine Quadrivalent 2021-2022 season.  Additional details were provided as follows: The case was reported by patient himself. The age at vaccination was not reported. The patient was receiving Pro-Air 90 mcg, 1 puff or takes when needed from January 2017 and Trelegy Ellipta inhalation powder 100 to 62.5 mcg use 1 inhalation by mouth daily from November 2019 for chronic obstructive pulmonary disease. The patient had an outpatient procedure to remove kidney stones in either August or September of 2021. He stated that he went in at 5 am and discharged later that evening, he had fully recovered.   The patient recently received his Flu vaccination, a week has passed and had a cold.  The physician prescribed him Cefuroxime Axetil. The healthcare professional consented to follow up. The reporter consented to follow up. This case has been linked with US2020AMR006146 for same patient, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR006146:same patient, same reporter
Post-vaccine associated urticarial vasculitis; This literature-study case was reported in a literature article and describes the occurrence of URTICARIAL VASCULITIS (Post-vaccine associated urticarial vasculitis) in a 66-year-old male patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIAL VASCULITIS (Post-vaccine associated urticarial vasculitis) (seriousness criterion medically significant). At the time of the report, URTICARIAL VASCULITIS (Post-vaccine associated urticarial vasculitis) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Biopsy: abnormal (abnormal) The biopsy specimen demonstrates an inflammatory process within the dermis, exhibiting urticarial-like features. In particular, there is a mixed infiltrate that is interstitial and perivascular composed of lymphocytes, monocytes, and neutrophils along with a few eosinophils with concomitant dermal edema. Inflammatory cells migrate through the vessel wall without fibrin deposition, although nevertheless there is focal leukocytoclasia and red cell extravasation, a constellation of findings consistent with urticarial vasculitis.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered URTICARIAL VASCULITIS (Post-vaccine associated urticarial vasculitis) to be possibly related.    Patient developed urticarial reaction process after receiving the COVID-19 Moderna vaccine.  Concomitant product use was not provided by the reporter.   ? No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start of the event after vaccination, a causal relationship cannot be excluded   This case was linked to MOD-2021-304252, MOD-2021-304413, MOD-2021-304414 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Follow up received by safety on 02-Sep-2021 included an Email received from a team and does not contain any new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start of the event after vaccination, a causal relationship cannot be excluded
While relaxed and sitting in a recliner, totally relaxed, my tracker device started pulsating noting that I was in the "cardio range".  The device note heart rate in 160s for several minutes. I checked my pulse manually and noted the same rate, consistent with the reading on the tracking device. This occured for several minutes.  Then, the rate dropped abruptly into the 40 range.  I was short of breath, nauseated, and with chest pressure during this time.   I was afraid to seek medical attention at that time, & didn't go to the ER.  In the days that followed, I continued to feel not quite right, and experienced ongoing heart palpitations.  I was seen by Dr. (primary care at clinic) on 3/31/21  an EKG in the office, and stated that it "looks like you had a heart attack".  I had never been told this before. She ordered a Holter Monitor for one day (24 hours).  Results were some abnormal heart beats.  Since that time, I have continued with heart palpitations. Primary Care Provider has referred me to Cardiology, and further tests are scheduled.   Additionally: thumb pain developed after 2nd shot, in early March 2021.  I was diagnosed w/ DeQuervans Tenosynovitis of left thumb on 7/7/21.  And, with Trigger Finger of rt thumb in September 2021.  I have never had these issues before.
Day after second vaccine my arm had a knot around injection site and  was extremely sore. The soreness continued and developed a larger knot and red ring around the knot. It took 1 1/2 weeks for the redness and knot to go away but my arm is still sore from the vaccine. Never had this happen with any other vaccine.
Swelling of face. Denies difficulty swallowing, shortness of breath, rash.  BP 136/68, RR of 16, HR of 84. Benadryl 25mg PO given at 1625 and was observed for an additional 15 minutes. No worsening of symptoms and slight improvement. He is here with his daughter who is an RN and feels comfortable taking him home. No further treatment initiated.
SIGNIFICANT PAIN AT INJECTION SITE AT FIRST FOLLOWED BY REDNESS AND SWELLING. AREA OF SWELLING DESCRIBED AS HAND SIZED.
Pt subsequent contracted a persistent strain condtition of herpes zoster or shingles/for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles; The vaccine did not prevent shingles as intended; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2009, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine adult health maintenance for the prevention of shingles in a clinic. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. In 2015, pt was treated in a clinic for a blistering vesicular outbreak which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles. The patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, patient had suffered and would continue to suffer significant medical expenses, and pain and suffering, and other damages. At the time of this report, the patient had not recovered from herpes zoster. The reporter assessed that herpes zoster was related to zoster vaccine live (ZOSTAVAX). Herpes zoster and vaccination failure were considered to be disabling by the reporter.
Received 2nd vaccine on 4/16/21 & developed hives all over with a burning feeling on 4/17/21. Went to ER and received IV Benadryl and Solumedrol. Sent home on oral prednisone. Feels much better today 4/19/21
Patient was instructed by her immunologist (followed for allergies and asthma) to have a Pneumovax vaccine (23 valent pneumococcal vaccine) due to low antibody levels against pneumococcus. Mom brought in patient to the clinic and vaccine given. Was encouraged to massage and move arm around after vaccine administration. 30 minutes after vaccine administration, patient started to complain local injection pain and warm. Once when patient and family returned home, patient took Tylenol for the pain. The next morning, patient woke up with localized swelling approx 10 cm around the injection area on left deltoid, redness, warmth and tightness to muscle with pain and decreased ROM. No fevers, no swelling outside of area mentioned above. Patient with out prior vaccine reactions. No other skin lesions. no difficulty breathing, no vomiting.
pain and a calcium deposit on her shoulder; This is a spontaneous report from a contactable Other HCP (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot no. and expiry date not reported), via an unspecified route of administration on unspecified date at a single dose for covid-19 immunization.  Medical history included calcium deposit on her shoulder.  The patient's concomitant medications were not reported.  It was reported that she was scheduled to receive her second dose next week. She stated that she has pain and a calcium deposit on her shoulder, in which is on the opposite arm of injection site. She clarified that calcium deposit was there prior to receiving the vaccine and was not related to the vaccine. She stated that she was supposed to go to physical therapy and take steroids but was wondering if she should wait to take the steroids before the second injection. Patient asked if she can use antipyretics before or after vaccination and if there is a delay to receive the second dose, should it be minimum of 3 weeks. She stated she was told 17-22 days the second dose could be given. Outcome of the event was unknown.
Dizzyness, lightheaded, feeling of passing out. Headache. Low blood pressure. High heart rate. Unstable. Unable to walk without help. Diagnosed with POTS
Vaccine administered beyond use date after the thawprocess; This spontaneous case was reported by an HCP and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date after the thawprocess) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date after the thawprocess). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date after the thawprocess) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 22 years and 4 months.  Concomitant medication of the patient was not reported.  The patient did not experience any adverse reactions after the administration of vaccine.  On 10-Jun-2022 the vaccination facility was made aware of administration of vaccines beyond use date after the thaw process while audit was conducted. Patient got Moderna with vaccine Ndc code 80777027399. Patient requested Pfizer-BioNTech COVID-19 Vaccine (12 plus).  No treatment information was provided by the reporter.
Allergy to tetanus; Initial unsolicited report received from a physician via other company (Pfizer) (Manufacturer report number: 2017147386) on 19-Apr-2017. This case involves a female patient (onset age not reported) who was vaccinated with a dose of TETANUS VACCINE AND TOXOID (Tetanus Toxoid) (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's relevant medical history and concomitant medications were not reported. On an unspecified date following vaccination (Latency unknown), the patient experienced allergy to tetanus vaccines and toxoid. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Moderately, severe redness, swelling at site Td immunization given 1/11.
Patient's left arm from elbow to shoulder was swolen, tender to touch, and warm. Patient has taken claritin, and tylenol. Patient has been icing the arm for 2 days now. Symptoms are slowly going away after 2 days but it still irritates the patient
no adverse affects reported; patients received doses of improperly stored Varivax; This spontaneous report was received from a health professional and refers to a patient of unknown gender and age. The patient's concurrent conditions, medical history, concomitant therapies, drug reaction and allergies were not reported.   On an unknown date in April 2019 (reported as 25-APR-2019 or 26-APR-2019), the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) subcutaneously, lot # R034396, expiration date 27-NOV-2020, (dose was not reported) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 38 degrees Fahrenheit for 72 hours. Sterile diluent was stored properly. There were no previous excursions reported. Data logger was not involved. No adverse effects was reported.  This is one of eleven reports from the same reporter.; Sender's Comments:  US-009507513-1904USA013268: US-009507513-1904USA013276: US-009507513-1904USA013272: US-009507513-1904USA013270: US-009507513-1904USA013275: US-009507513-1904USA013265: US-009507513-1904USA013269: US-009507513-1904USA013210: US-009507513-1904USA000187: US-009507513-1904USA000191:
passed away from Covid-19 Pneumonia 24OCT2021; Caught Covid-19 20OCT2021/Mom developed a cough; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 PNEUMONIA (passed away from Covid-19 Pneumonia 24OCT2021) and COVID-19 (Caught Covid-19 20OCT2021/Mom developed a cough) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Caught Covid-19 20OCT2021/Mom developed a cough) (seriousness criterion hospitalization). On 24-Oct-2021, the patient experienced COVID-19 PNEUMONIA (passed away from Covid-19 Pneumonia 24OCT2021) (seriousness criteria death, hospitalization and medically significant). The patient died on 24-Oct-2021. The reported cause of death was COVID-19 pneumonia. It is unknown if an autopsy was performed. At the time of death, COVID-19 (Caught Covid-19 20OCT2021/Mom developed a cough) outcome was unknown.            No Concomitant medication were provided by the reporter  No treatment medications were provided by the reporter  This case concerns a 58-year-old, female patient with no relevant medical history reported, who experienced the unexpected events of COVID-19 Pneumonia and COVID-19. The events occurred 6 months and 28 days after the second dose of mRNA-1273 had a fatal outcome, with death occurring the following day. No autopsy report was disclosed. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 in not affected by this report.   This case was linked to MOD-2021-365577 (Patient Link).; Sender's Comments: This case concerns a 58-year-old, female patient with no relevant medical history reported, who experienced the unexpected events of COVID-19 Pneumonia and COVID-19. The events occurred 6 months and 28 days after the second dose of mRNA-1273 had a fatal outcome, with death occurring the following day. No autopsy report was disclosed. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 in not affected by this report.; Reported Cause(s) of Death: COVID-19 pneumonia
Patient started to fill faint and pale. Patient was clammy and got dizzy. Patient has set there for 15 minutes and when she started to get up started feeling  faint and hot. Patient waited about 10 or 15 minutes more. Her color improved and was feeling better and no issues when she left.
SkinRash, UrticariaPruritus & HYPERtension  Narrative:
Information has been received from a nurse practitioner concerning a 17 year old female patient with no known drug allergies or pertinent medical history who on 13-AUG-2010 was vaccinated with the third dose of GARDASIL (lot number 666163/0664Z). There was no concomitant medication. The nurse reported that over the weekend (approximately on 14-AUG-2010) the patient had been having blackouts and fainting even while sitting down. The nurse stated that the patient did not have adverse effects after her first or second dose of GARDASIL. No laboratory tests were performed. At the time of the report the patient had not recovered. The patient was being seen by the nurse practitioner on 16-AUG-2010. Follow-up has been received from a nurse practitioner, concerning a 17 year old female student with anxiety who on 13-AUG-2010, was vaccinated IM in the left arm with the third dose of GARDASIL (lot# 666163/0664Z) at 15:30 pm. There was not illness at the time of vaccination. on 13-AUG-2010, the patient went to work (lifeguard) and felt weak. On approximately 14-AUG-2010 "mostly on 14th and 15th" was feeling like she would pass out; the patient did not have a syncope episode (she just felt like she was going to). The nurse practitioner spoke to the patient's mother on 17-AUG-2010, and she stated that the patient was feeling much better, but still felt dizzy and weak, once on 16-AUG-2010, while playing soccer and had to rest for several minutes and recovered. The patient made an appointment and was seen in the physician's office. On 16-AUG-2010, a blood pressure and heart rate test were performed. At the time of the report, the patient had recovered. No further information is available.