chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed a vesicular rash; This is a spontaneous report from a contactable Other HCP. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Jan2021 at single dose for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient experienced developed a vesicular rash on 17Jan2021, it was described as 'the patient developed a vesicular rash on day 6. This was the second vaccine. It's not a diffused drug reaction like rash, it's the vesicular'. The outcome of the event was unknown. Information on the Lot/Batch number has been requested.
Sinus infection; Viral infection; Fatigue; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus infection), VIRAL INFECTION (Viral infection), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Vaccination site pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced FATIGUE (Fatigue) and VACCINATION SITE PAIN (Vaccination site pain). On an unknown date, the patient experienced SINUSITIS (Sinus infection) and VIRAL INFECTION (Viral infection). In 2021, FATIGUE (Fatigue) and VACCINATION SITE PAIN (Vaccination site pain) had resolved. At the time of the report, SINUSITIS (Sinus infection) and VIRAL INFECTION (Viral infection) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Colonoscopy: Unknown.  Concomitant product use was not provided by the reporter.  The patient got booster and arm was sore, virus, fatigued and sinus infection with Humira (Adalimumab). On unknown dates, the patient experienced virus and sinus infection. In 2021, the patient experienced got booster and arm was sore and fatigued.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for Humira (Adalimumab) for the events of got booster and arm was sore, virus, fatigued and sinus infection was not provided.  Treatment information was not provided.  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.
I got the shingles after I got my vaccine / Suspected Vaccination failure; I got the shingles after I got my vaccine; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult 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 reported as follows: This case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient experienced shingles after he/she got his/her Shingles vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
right trigeminal neuralgia; Information has been received from a lawyer concerning a case in litigation and refers to a 63-year-old patient of an unknown gender. No information about the patient's medical history, concurrent conditions and concomitant medications was provided. On 11-NOV-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) injection (dose, route of administration, vaccination site, lot # and expiry date were not specified), prescribed by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. As a result of zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered right trigeminal neuralgia diagnosed on 22-OCT-2014. The outcome of the event was unknown.
This spontaneous report was received from a nurse and refers to an unspecified patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of (Merck) VARIVAX (lot # L01067, expiration date 14-APR-2017, exact dose and route of administration were not reported). No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information is not expected because there was no consent for follow-up.
Patient is a 88 y.o. male patient of MD with history of CAD s/p stents, hypertension, hyperlipidemia, type 2 DM, chronic anemia presented with melena and black tarry stool   Acute on chronic anemia d/t ABLA with hemorrhagic shock Iron deficiency anemia Colon adenocarcinoma Presented with melena mixed with bright red blood S/p right hemicolectomy with ileocolic anastomosis on 2/9 per Dr. CT a/p on admission with post-surgical changes. Non-acute Initial CBC with Hgb 6.1 (from 7.4 week prior). Only improved to 6.5 after 2uPRBCs EGD 2/22 with 2 duodenal ulcers, hemostasis via epinephrine Has required 6 total units of PRBCs (5 units prior to EGD) Cont IV PPI bid, carafate Holding Plavix as risks > benefits (DES in 12/05/2022).  Per cardiology recommendation 11/2022: Continue aspirin 81 mg daily indefinitely and clopidogrel for 3 months  On empiric H pylori coverage Clinically UGIB is resolving. BMs normalizing,  no further tachy response.  Hgb 7.5-8,  stable over last few days Surgery following, recommending to hold ASA for 14 days and then resume   Acute hypoxic respiratory failure d/t COVID-19 infection AHRF multifactorial. Post-op resp insufficiency, poor O2 carrying capacity, COVID Tested positive 2/26. Symptom onset 2/26. Wife also positive. Vaccinated x2 Required 4L NC initially, , now down to room air CXR without vascular congestion or consolidation Cont supplemental O2 to maintain goal SpO2 > 92% Decadron 6mg daily for 10 days  Hold off on Remdesivir   Hypomagnesemia Hypophosphatemia Replaced.  CAD  s/p PCI of LAD with DES 12/09/2022   Per cardiology note from December patient was advised to continue DAPT for at least 3 months but according to patient was later instructed to stop aspirin and continue Plavix. Continue statin Holding plavix   Hypertension Held home blood pressure meds on admission as blood pressure soft.   Will restart   Hyperlipidemia Continue statin   Type 2 DM -A1c not at goal A1C 9.1 on 1/24/2023 on metformin, glipizide and pioglitazone at home Continue sliding scale and every 4 hours checks Lantus increased for hyperglycemia due to steroids.    Nocturnal Hypoxia Suspect OSA Recommend outpatient sleep study    Chronic urinary retention Has indwelling Foley catheter, will f/u with Dr  Continue Flomax   Severe protein caloric malnutrition
Pt came to clinic and was seen for swollen legs, knots on both thighs where shots were given, fever 101 degrees, mom stated. Mom was giving Tylenol for pain. Doctor told mom to continue Tylenol every 4 hours, Motrin every 6 hours, warm compresses to legs.
Swelling between neck and elbow in right arm.  Limited mobility in right arm.  Muscle pain in right arm after receiving Pneumovax 23.
As sick as the flu; Initial information regarding this unsolicited valid non-serious social media case received from a consumer (patient) on 19-Nov-2020.  This case involves a patient with unknown demographics who as sick as the flu (Illness), when received INFLUENZA VACCINE.  Relevant medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was as sick as the flu (Illness), It out the patient in bed for 3 days last year, unknown latency following the administration of INFLUENZA VACCINE.  Relevant laboratory test was not reported.  It was not reported if the patient received a corrective medication.  At the time of reporting, the outcome was unknown for the reported events.  There will be no information available on batch number for this case.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 06-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported that, first dose of vaccine was administered after 11 days from first puncture.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up received on 29-sep-2021 contains no new information
Infanrix was given to pt. as part of her routine vaccinations. The dose was expired, and pt. had to return to clinic to be re vaccinated.
Around March 12, 2021 I started getting a numbing feeling. From the left side of my right leg down to my ankle. The feeling comes and goes, usually in the morning and then goes away sometime during the day. I saw my doctor for a regular checkup. They did basic bloodwork and doctor advised me to lay off the sweets.
This spontaneous report was received from a physician via company representatives and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions or concomitant therapies were not reported. On 13-OCT-2014, the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 "10 Single DS 0.5 ml LVls 10SDV", lot # K004148, expiration date 10-MAY-2015 (route was not reported). This vaccine was improperly stored exposed to two temperature excursions, one for a sum of 64 hours at a highest temperature recorded of 47 degrees F (8.333333333 degrees C) and other for a sum of 72 hours at a lowest temperature recorded of 34 degrees F (1.111111111 degrees C). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported. There was no product quality complained involved. This is one of several reports received from the same reporter. Additional information has been requested.
About a week after receiving my booster dose, the pain in my right shoulder had markedly improved and instead now my left shoulder was extremely painful, hard to move/lift and hard to lay on. I saw a PA for an orthopedic surgeon who ordered imaging of my left shoulder and it indicated a progression of mild arthritis to severe arthritis in my left shoulder. They ordered a complete shoulder replacement of the left shoulder but it has been delayed due to other health issues.
Information has been received on 04-DEC-2018 regarding a case in litigation from a lawyer concerning a male patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 29-DEC-2009, the patient's healthcare provider at a clinic administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. On or about 30-DEC-2016, the patient was treated by the patient's healthcare provider at a clinic for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, 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, 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 include care for hospitalization, 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; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is unknown. The causality of the events is related. Additional information has been requested.
Pt reported swollen tongue upon waking up from a nap. Called around 6pm.
1. Patient was administered Pfizer monovalent covid 19 vaccine after authorization for use expired April 18, 2023. 2. Patient was prescribed Pfizer Bivalent covid 19 vaccine and was administered Pfizer monovalent covid 19 vaccine in error.
This spontaneous report was received from a pharmacist 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 28-AUG-2018, the patient was vaccinated with a dose of VARIVAX lot # R002054, expiry date 22-JAN-2020, in a right leg subcutaneously for prophylaxis, and was also administered a dose of PROQUAD lot# R003292, expiry date 31-JUL-2019, in the left leg subcutaneously for prophylaxis. No lot information was provided for sterile diluent used to reconstitute the vaccines. No adverse effects were reported.
Uncontrolld shivering, nausea, weakness, vertigo, thirst, disturbed sleep for 24 hrs.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 02-OCT-2015, the patient was vaccinated with RECOMBIVAX HB (dose, frequency and lot# were not reported) intramuscularly. It was reported that the patient will receive another dose of RECOMBIVAX HB on 02-OCT-2015. No adverse effects were reported. Additional information has been requested.
"Pain at injection site"; "Nausea"; "Abdominal pain"; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN ("Pain at injection site"), NAUSEA ("Nausea") and ABDOMINAL PAIN ("Abdominal pain") in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced NAUSEA ("Nausea") and ABDOMINAL PAIN ("Abdominal pain"). On 29-Apr-2021, the patient experienced VACCINATION SITE PAIN ("Pain at injection site"). On 28-Apr-2021, NAUSEA ("Nausea") and ABDOMINAL PAIN ("Abdominal pain") had resolved. On 29-Apr-2021, VACCINATION SITE PAIN ("Pain at injection site") had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication and treatment medication was provided.
COVID vaccine breakthrough case. Pfizer 1/29/21 EL9261, 2/19/21 EM9810 and boosted Moderna 8/18/21 043B21A.
pt exp w/in 48 hr cough,cold,chest congestion; exam revealed case of varicella
Uncomfortable side effects; This case was reported by a consumer and described the occurrence of adverse event in a adult 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 2 years after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was recovered/resolved.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient took the first shot and had uncomfortable side effects that lasted 2.5 days. The reporter asked if same side effects would occur after the second shot.
day 1 aches soreness at site , day 3 diahrrea,  day 8 sedness, slight heat, size increasing to size of my palm, itchiness at times, itchy throat   lasting about 6 days before fading, still occasionally itchy
felt tired and headaches; felt tired and headaches; brain fog/lack of concentration; brain fog/lack of concentration; This is a spontaneous report from a contactable consumer, the patient. A 16-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 07May2021 at 13:45 (at the age of 16-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to tree nut. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not take any concomitant medication. The patient previously took BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 16Apr2021 at 13:30 (at the age of 16-year-old) as a single dose for COVID-19 immunisation. On 08May2021 at 12:15, 2 days after second shot, the patient experienced tired and headaches. That all disappeared but the patient still had brain fog/lack of concentration 5 days later. It was also reported as that no adverse reaction after first dose, the patient just wanted to report this and was really hope the brain fog goes away. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events tired and headaches was recovered on an unknown date in May2021 and of the event brain fog and lack of concentration was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Jittery; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 26May2021 20:30 (Lot number: Ew0186) at the age of 48 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Copd" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Lidocaine, reaction(s): "Known allergies :Lidocaine".  The following information was reported: FEELING JITTERY (non-serious) with onset 27May2021 13:00, outcome "recovering", described as "Jittery". Therapeutic measures were not taken as a result of feeling jittery.  Additional information: The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not tested COVID post to the vaccination. Patient not had COVID prior to vaccination. Patient was not tested for COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
1) Low-grade fever (100 degrees when checked, after the worst was over, likely higher temperature  prior to temperature check). Began at 2am on 4/21 and persisted until 8pm on 4/21. Acetaminophen 325 was taken at 6pm on 4/21 to help reduce fever.  2) Chills. Began at 2am on 4/21 and persisted until 8pm on 4/21. Acetaminophen 325 was taken at 6pm on 4/21 to help reduce fever.  3) Hot flashes. Began at 2am on 4/21 and persisted until 8pm on 4/21. Acetaminophen 325 was taken at 6pm on 4/21 to help reduce fever.  4) Headache. Began at 2am on 4/21 and persisted until 8pm on 4/21.  5) Body aches. Began at 4pm  on 4/20 and persisted until 8pm on 4/22 at 12:30pm.  6) Nausea. Began at 2am on 4/21 and persisted until 11am on 4/22.   7) Anorexia. Began at 2am on 4/21 and persisted until 10am on 4/22.  8) Fatigue.  Began at 2am on 4/21 and persisted until 1pm on 4/22.
Lump/swelling at injection site; Lump/swelling at injection site; swollen tender left clavicular lymph node; swollen tender left clavicular lymph node; This is a spontaneous report from a contactable nurse. This 32-year-old female nurse (patient) reported for herself. A 32-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 3 intramuscular, administered in Arm Left on 08Oct2021 11:45 (at the age of 32 years) (Batch/Lot Number: EW018S) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation at hospital. The patient was not pregnant at the time of vaccination. The patient 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. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) dose 1, administered in Arm Left on 26Dec2020 (at the age of 31 years) (Batch/Lot Number: EK5730) and dose 2, administered in left leg on 14Jan2021 (at the age of 31 years) (Batch/Lot Number: EL8982) for COVID-19 Immunization. On 09Oct2021 12:00 the patient experienced Lump/swelling at injection site, swollen tender left clavicular lymph node. The patient did not receive any treatment for the adverse events. The clinical outcome of the events was recovering at the time of report.  Follow-up attempts are completed. No further information is expected.
Systemic: Patient given vaccine with ml/25G x 1inch safety needle. During administration, needle detached from syringe, some vaccine leaked out of syringe, Mild, Additional Details: Alerted NP who spoke with collaborating physician. Advised to not administer anymore vaccine today & schedule for second dose. Patient aware and agreed with decision made.