chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she mentioned that her  Father, as soon as he got the COVID vaccine, he passed away shortly after; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 89 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death) with onset 19May2021, outcome "fatal", described as "she mentioned that her  Father, as soon as he got the COVID vaccine, he passed away shortly after". The patient date of death was 19May2021. The reported cause of death was "she mentioned that her  Father, as soon as he got the COVID vaccine, he passed away shortly after". The reporter mentioned that the patient was not in good health. He was on hospice. The reported does not have the manufacturer, lot or expiration. She believes it was the Pfizer, but was not sure. It was not reported if an autopsy was performed.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Event unknown cause of death is assessed as related until sufficient information is available to confirm an unrelated cause of death. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: she mentioned that her  Father, as soon as he got the COVID vaccine, he passed away shortly after
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in an unspecified number of patients 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 age at vaccination was not reported. Reporter knew people who after receiving Shingles vaccine, got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Over the course of three days he had severe 10/10 pain at injection site.  On the third day he developed a very large bruise that encompassed his entire upper arm distal to the injection site. Within a week the bruise moved down to his forearm and swelling began. He has never lost sensation or has had any tingling to the hand or extremity. To this day his health care professionals are saying to not let this prevent getting a second vaccine. He is a stubborn man and does not like hospitals. I am a critical care pediatric RN and I will not be taking him back for a second vaccine.
slight swelling of face between lip and chin, left side of face swollen; having leg muscle twitching; mentions ripples going to legs; 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 SWELLING FACE (slight swelling of face between lip and chin, left side of face swollen), MUSCLE TWITCHING (having leg muscle twitching) and SENSORY DISTURBANCE (mentions ripples going to legs) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Anxiety and Lip biopsy.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (slight swelling of face between lip and chin, left side of face swollen), MUSCLE TWITCHING (having leg muscle twitching) and SENSORY DISTURBANCE (mentions ripples going to legs). At the time of the report, SWELLING FACE (slight swelling of face between lip and chin, left side of face swollen), MUSCLE TWITCHING (having leg muscle twitching) and SENSORY DISTURBANCE (mentions ripples going to legs) outcome was unknown. Not Provided      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.   Concomitant product use was not provided by the reporter.   Treatment information was not provided.
The night she received the shot she developed pain, tenderness, redness and swelling at the injection site. The next morning had headache, chills, heart felt loud and fast, could not think, could not remember even normal things like how to turn on TV, insomnia. Went to store and became weak and breathing hard with minimal activity, had to sit down and rest before leaving. Symptoms lasted about 3-4 days and at this point have resolved.
Gradual onset of generalized itching. EMS activated and patient transported to emergency room at approximately 5:20 pm.
Stiffness in arm vaccine was given in. Tender under arm. Tingles in injected arm. bruising Knot from injection Lasted for 2 days after injection.
Vertigo when laying down or changing head position. Doctor examined ear and stated there was excess wax in right ear. Ear was flushed with 1.5% hydrogen peroxide at office and by myself for the 5 days following exam. Blockage was cleared and vertigo ceased to be a problem.
Lt lower leg DVT and multiple b/l pulmonary emboli.  Second vaccination given 2-25-21. Shortness of breath and fatigue started about 3-15-21. Severe dyspnea and hemoptysis started 3-25-21 resulting in EMS transport, hospitalization, IVC umbrella filter and Xarelto.
per pt mom pt spiked temp 2 hrs p/vax t105.8 R APAP & sponge baths 7-8PM called ER & talked to ER RN; told to cont APAP & sponging w/warm H20 but not to come in; pt had red rash on face, back & abd;
Nauseous; Dizzy; Tired; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168) via an unspecified route of administration in the left arm on 14May2021 at 15:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included sertraline (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date. On 21May2021 at 05:00, the patient experienced nauseous, dizzy and tired. Ten days after, and still felt tired, dizzy and nauseous at times, at the time of reporting. The events did not result in any of these doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event nauseous, dizzy and tired was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Initial headache. Took ibuprofen later afternoon at home with food.  Saturday morning headache continued.  Took ibuprofen with food.  Ate lunch 2 p.m.  At home achy at 2:30 p.m. Throbbing headache.  Went to bed.  Got up very dizzy.  Threw up at 3:30 p.m.  Very tired and thirsty and not hungry.  Deep sleep through the night.  Sunday morning feeling better, got outside, ate full meal at noon.
PREVNAR 13 was given to patient under 65 years old, instead of the PNEUMOVAX 23 since patient was smoker and has history of pneumonia. Pt did not have any adverse effects from the vaccination, just the vaccine was given at the wrong dosing schedule
Initial report received from a health care provider on 12/Oct/2005. A 48 year old female patient with a pre-existing medical history reported as "no egg allergies," had been hospitalized for unspecified reasons, and received an injection of Fluzone SV 2005-2006, lot number unknown; and Pneumovax, manufacturer lot number unknown, at the time of hospital discharge on 05/Oct/2005. The sites and routes of vaccination were unknown. Five days later, she developed a scattered pinpoint rash on her torso that became generalized over her entire body. The patient had no illness at the time of vaccination, and information regarding other medications was unknown. The patient was examined in the emergency room and treated with steroids and Benadryl. Per the reporter, the patient returned to the emergency room 12 hours later and received the same treatment. The patient was examined during an office visit on 12/Oct/2005, and the symptoms had resolved. The patient was not hospitalized for these events. At the time of this report, the patient had recovered. Follow-up information received on 28/Nov/2005 from a health care professional. It was reported that the patient had been hospitalized due to a possible vascular occlusion of the third right finger prior to receiving the vaccine on 05/Oct/2005. An angiogram at the time of hospitalization was negative. The patient had not received any influenza vaccines in the past. Following the event of generalized rash on 10/Oct/2005, the patient improved and the reaction had "mostly resolved" at the time of this report (it was previously reported that the patient had recovered). No other information was provided at this time. Follow-up information received on 07/Dec/2005 from another company (reference number WAES0510USA06778). It was reported that the Fluzone SV 2005-2006 and the Pneumovax vaccinations were administered in opposite arms, but no specific site was reported. Following the onset of the events on 10/Oct/2005, the patient was seen in an emergency room twice on the same day. On the first visit she was treated with oral prednisone and diphenhydramine hydrochloride (Benadryl). During the second emergency room visit, she was treated with IV steroids and diphenhydramine hydrochloride (Benadryl)., and was placed on oral prednisone. It was noted that the patient experienced a local site reaction of the arm, but it was not reported whether the reaction occurred at the site of the Fluzone SV 2005-2006 or Pneumovax injection. The patient was seen by the physician on 12/Oct/2005 and the symptoms had resolved at that time. The reporter noted that the patient was not hospitalized for the events. At the time of this report, the patient had recovered. The reporting physician considered the diffused rash and local site reaction of the arm to be disabling and other important medical events. Based upon this new information, this case is being upgraded to serious.
LPN administered a third dose of Shingrix on July20, 2023 when the patient had already received their second and final dose on April 15, 2022. There was not adequate documentation on April 15, 2022 nurse visit to register with the system that he received the 2nd and final dose. The third dose was given in error.
pt recvd vax & had episode of pallor w/in 1st hr followed by 3-6 hrs of deep sleep; did not seem to respond to family'stimulations;
t105.5, faint diffuse, mac pap rash, diffuse petechiae & irritability; adm to hos, thrombocytopenia all other test neg BC neg, urine antigens neg;
very tired after the third Moderna COVID-19 dose; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (very tired after the third Moderna COVID-19 dose) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A, 007M20A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Sep-2021, the patient experienced FATIGUE (very tired after the third Moderna COVID-19 dose). At the time of the report, FATIGUE (very tired after the third Moderna COVID-19 dose) outcome was unknown.        Concomitant medication was not reported. Treatment information was not reported.
No additional adverse effects reported.; One patient received an improperly stored dose of VARIVAX; This spontaneous report has been received from an office manager referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug/allergy reactions, and concomitant therapies were not reported.  On 20-APR-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose, route of administration, vaccination scheme and anatomical site of administation were not reported;  lot number S022755, expiration date 22-JUL-21) as prophylaxis. Additionally, the sterile diluent (MERCK STERILE DILUENT) used to reconstitute the vaccine was reported as "properly stored".  The administered dose of the vaccine was stored in a temperature between 6 degrees Fahrenheit (°F) to 14 °F, in a timeframe of 90 minutes, as recorded by a data logger. The previous temperature excursion reported was 15°F to 46 °F  in a timeframe of 36 hours.  No additional adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2004USA006968:
24 June 2020, 7 days after receipt of above 4 immunizations, patient developed bilateral lower extremity lesions consistent with Henoch Schonlein Purpura. No other clinical systemic symptoms and no preceding symptoms consistent with an infection. Laboratory assessment was within normal limits without systemic evidence of inflammation. Lesions continuing to appear and disappear every 5-7 days, decreasing in frequency, but not completely resolved.
Headache Low grade fever Muscle aches/weakness Swelling/hardness/redness at injection site Nausea  Dizziness
25 yr old male presented to ED, for chest pain since Sunday. Pt describes the chest pain as centrally located in the chest and associated with a pressure. The pressure is worse when leaning forward and taking a deep breath. Pain rated worst at 4/10 on Sunday. Pt states that on Saturday he did start feeling "flu" like with aches, feverish, slight neck pain, and HA but never recorded temperature. Pt does report receiving smallpox vaccine on 27 June.  Pt denies changes in vision, n/v, radiating pain elsewhere in the body or any recent illness.   ED COURSE: Sent for CP since Sunday. Radiating L side CP described as a pressure worse when leaning forward and taking a deep breath. Denied any other s/s related to CP. Pt was given IV toradol and pain nearly resolved. Initial troponin level .752, EKG revealed no STEMI. CXR unremarkable. ED physician did informal bedside ultrasound and stated no effusion noted and normal EF. Cardiology was consulted who recommended admission for serial troponins, telemetry monitoring for dysrhythmia.
Large area of redness-about 6"x4" (spreading), area is warm to the touch, rash at onset, itching 4 days after injection.
EMS contacted due to pt with c/o SOB; EMS witnessed cardiac arrest of pt; intubated; several rounds of CPR, achieved ROSC; labs in ED showed positive test for COVID; evidence of anoxic brain injury; family made pt a DNR and he died in the hospital
Developed Covid-19 with symptoms and positive antigen test on 5/2. Not an adverse vaccine event.
Received booster from expired vial; On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received booster from expired vial) and UNDERDOSE (On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021 at 1:20 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received booster from expired vial) and UNDERDOSE (On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received booster from expired vial) and UNDERDOSE (On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.  On 29-Oct-2021, the patient received first dose of Sanofi Pasteur (Intramuscular) (Left Arm).1 dosage form (batch no. W731AB).  The patient had no reaction post vaccination.
Acne around my eyes and around my mouth, even on my nose and my fore head; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old patient received BNT162b2 (BNT162B2), in May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: ACNE (non-serious) with onset May2022, outcome "unknown", described as "Acne around my eyes and around my mouth, even on my nose and my fore head".  Additional information: The patient received 2nd Pfizer booster shot 2 month ago. From that day patient got Acne around eyes and around mouth, even on nose and fore head and mentioned that patient never had skin problem in whole life.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient had symtpoms of dizziness, racing heart rate, elevated BP, tingling in the legs.
Moderate ?> Severe pain & discomfort to Muscles , Joints  & Back (worst) also swelling of left knee. Lymph node under left arm which resolved within 1 week. Continued joint & muscle pain  currently. Spoke with PCP  who recommended to speak with Asthma & Allergy provider doctor who advised NOT to take 2nd dose. Seen by Ortho-spine doctor who ordered labs & also PT prescription. Pain control by OTC medication ( Tylenol previous & Aleve (back & muscle pain) type.
missed second dose schedule; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Aug-2021 and was forwarded to Moderna on 09-Aug-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed second dose schedule) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) 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) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed second dose schedule). On 25-Apr-2021, PRODUCT DOSE OMISSION ISSUE (missed second dose schedule) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications are provided by reporter.  It was reported that patient missed his second scheduled dose on 25-Apr-2021 (reason not specified).   Treatment information was not provided.
I now have POTS (autonomic dysfunction) as a result of the vaccine. They told me it was anxiety and I was fine. I went to a cardiologist to confirm that something was wrong and have been unable to work for 6 months. I just started working again as a registered nurse but the pain, weakness, and vertigo stays with me everyday. I think my days as a registered nurse may be numbered.
102.5 degree F fever; A Spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed 102.5 degree F fever.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 29 Dec 2020, approximately 12 hours prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 30 Dec 2020. the patient began to develop a fever of 102.5 F. Treatment for the event included acetaminophen.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event 102.5 F fever was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event of pyrexia, a causal relationship cannot be excluded.
Symptoms of UTI are still present despite multiple negative urines, two cycles of antibiotics, bladder and kidney ultrasound, and vaginal exam and cultures. All tests are now negative despite symptoms and the presence of non-hemolyzed blood in my most recent urine sample from 9/3/2021.
36 year old with no significant history, current medications or known allergies s/p 2nd Pfizer vaccine with LOC and syncope. Patient lost consciousness while in waiting area following his vaccine. He struck the right side of his head and maxilla with resultant contusion/ abrasion of right sided face/forehead/temple. He was unconscious for approximately one minute with no recollection of the event. He was immediately alert and oriented but did also have blister and right sided tongue trauma. There was no evidence of any incontinence or confusion. Patient appeared pale and reported nausea, lightheadedness with increasing head pain after awakening. Patient was evaluated by on site APP and EMS, ECG/BP/Pulse/Oxygenation assessed. Declined BSL eval. Vitally stable, oriented and able to ambulate independently at time of discharge. Recommendations were given for hospital follow up today to evaluate any possible head/neck trauma and review bradycardia.
Chills and fever beginning at 10 p.m.. Chills ceased during the night. Mild fever continued until around 10 a.m. Fatigue all day 5/21/21.