chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a 56 year old physician regarding himself with no pertinent medical history for drug reactions/allergies. On 03-AUG-2012, the patient was vaccinated with ZOSTAVAX, subcutaneously. Lot number was not reported. There were no concomitant medications reported. On 06-AUG-2012, the patient experienced swelling and inflammation at the injection site, after receiving a dose of ZOSTAVAX. He also developed pain in the neck and both ears after receiving the dose. The patient also developed hoarseness in the vocal cord. A CAT scan (Computerised axial tomogram) was done on his neck and it was negative. His symptoms improved and he doesn't have the pains anymore. No treatment information was reported. The patient sought unspecified medical attention. The outcome of the events were reported as recovering at time of this report. Additional information has been requested.
Developed fever of 101.0 F, chills, body aches, headache and nausea approximately 12 hours after receiving vaccination. Symptoms lasted  26 hours. Took 2 doses of Tylenol which slightly improved body aches- but did not lower fever.
This spontaneous report was received from an unspecified reporter and refers to a 2 patients of unknown age and gender. On 23-JUN-2016, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (dose, frequency, route of administration and indication were not reported lot# L048462 with expiration date 02-DEC-2017). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
After first dose of Gardasil given and completed, client briefly lost consciousness.  Client leaned to right of chair, caught by RN, Left arm contracted, returned to consciousness within one minute or less.  Alert and oriented immediately after episode.  Mildly pale, not dizzy.  Stayed 15 minutes, drank juice and then left accompanied by mother without further incident.
pt recvd vax & exp sl nausea w/in 24hrs p/vax;exp flu-like sx,malaise,post-nasal drip,the sensation of swallowing,& felt worse w/in 82hrs p/vax;sx were not treated;
initial puffiness & redness; pt complains of pain radiating down the lt arm, particularly in the joints; pain seems to originate from the site of inject;
No adverse effects reported; one patient received one dose of improperly stored ROTATEQ; This spontaneous report was received from an office manager and a healthcare business professional referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 01-AUG-2019, the patient received one dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot # R025713 (verified to be a valid lot number), expiration date reported and established as 20-JUN-2020, for prophylaxis. The vaccine was improperly stored at a temperature of 33.9 degrees Fahrenheit during the time frame of 20 minutes. The previous temperature excursion was 30.3 degrees Fahrenheit for 93 hours and 50 minutes. The stability information was updated: total time and lowest temperature below 36 degrees Fahrenheit (30.3 degrees Fahrenheit) for 90 hours and 7 minutes, total time and lowest temperature below 36 degrees Fahrenheit (30.5 degrees Fahrenheit) for 1 hour 45 minutes and total time and lowest temperature below 36 degrees Fahrenheit (35.2 degrees Fahrenheit) for 2 hours 5 minutes. The most recent temperature as total time and lowest temperature below 36 degrees Fahrenheit (33.9 degrees Fahrenheit) was update to 40 minutes, instead of the previously reported 20 minutes. The call was made because of a data logger. No adverse effects were reported. No additional doses were administered.
Big hives went up her neck and big patches of hives up her face; A spontaneous report was received from a consumer concerning a 42 year old female patient who experienced big hives that went up her neck and big patches of hives up her face (angioedema).  The patient's medical history included high immunoglobulin E. No concomitant product use was reported.  On 12 FEB 2021, the patient received first of two planned doses of mRNA-1273 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On an unspecified date, after receiving the vaccine, the patient broke out into hives.   On 24 FEB 2021, the patient got big hives that went up her neck and big patches of hives up her face. The patient's allergist told her that it was normal as she had high immunoglobulin E (IgE) and she was susceptible to allergies. The patient's allergist gave her a Medrol (methylprednisolone) dose pack and hives were not as itchy anymore and patient felt better. Treatment included Medrol dosepack.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event, big hives went up her neck and big patches of hives up her face (angioedema) was considered as recovering.; 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, a causal relationship cannot be excluded.
This spontaneous report as received from a pharmacist via company representative refers to a female patient of unknown age. No medical history and current conditions were reported. On an unknown date in March 2015 (reported as within the past week) the patient was vaccinated with ZOSTAVAX (dose, lot number was unknown) for prevention of shingles. No concomitant medications were reported. On an unknown date in March 2015 (reported as within hours after receiving ZOSTAVAX) the patient experienced a rash, redness and swelling around the injection site. The patient received topical hydrocortisone as a treatment. Patient sought medical attention, saw pharmacist. No product quality complaint was involved. The outcome of the events rash, redness and swelling around the injection site was unknown. The reporter causality was not provided. No further information was provided. Additional information has been requested.
angioedema without urticaria 24h after COVID-19 vaccine (Moderna dose #1)
no react-no local react, no fever, no fussiness, no drowsiness, no loss of appetite) Sudden death;
Patient received influenza immunization. Patient is still experiencing pain at the injection site more two weeks after immunization. Patient reports no signs of allergic reaction or infection but is following up with a physician to manage symptoms.
other zoster related injuries; shingles; Initial information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown gender whose age at the time of report was 69 years old. No information about the pt's medical history, concurrent conditions or concomitant medications was provided. On an unknown date (reported as "on or about 41574"), the pt was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) by a physician at a healthcare facility for the long-term prevention of shingles and zoster-related conditions. Subsequently, on unknown dates, the pt was treated by the physician at the healthcare facility, and other healthcare providers, for the following injuries resulting from the pt's zoster vaccine live (ZOSTAVAX) use: shingles and other zoster related injuries. The outcome of the events was not provided. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Pain in arm; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), CHILLS (Chills) and PYREXIA (Fever) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011C20A) for COVID-19 vaccination.    Co-suspect product included non-company product ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) for an unknown indication.    The patient's past medical history included No adverse event (Medical history was not reported.). Concomitant products included QUINAPRIL and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) (unknown route) at an unspecified dose. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, PAIN IN EXTREMITY (Pain in arm), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.             Treatment information included Ice pack. Action taken with mRNA-1273 in response to the event was not applicable   Reporter did not allow further contact
Fully vaccinated and booster on August 22.   LOT NUMBERS OF VACCINES NOT DOCUMENTED. COVID infection breakthrough.   Inpatient hospital stay to a general medical unit.
Patient reported red, warm, raised rash  under injection site wrapping around upper arm, not around injection site. Started Friday night and cleared by Sunday.
NOTE:  This was the booster shot Standard: body aches, low grade fever, tiredness, pain at injection site - same as last time.  This is resolved except for injection site (Oct 6) Not standard:  1) My neck hurt REALLY bad, the Tylenol did not relieve it (2-500mg pills every six hours).  It was hard to stay still because of the pain.  I finally got a nap in in the afternoon (Oct 5) and was up and down all night.  The pain is now GONE (Oct 6) 2) Swollen where the shot was injected.  It's pretty big.  Still big and sore. (Oct 6) 3) Swollen glands under my armpit - it's eased up but is very sore. (Oct 6)
mild sx and positive Ag test; mild sx and positive Ag test; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EL3247), on 25Feb2021 as dose 2, single (Lot number: EL3247), on 26Oct2021 as dose 3 (booster), single (Lot number: FF2589) and on 08Apr2022 as dose 4 (booster), single (Lot number: FL3197) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15May2022, outcome "unknown" and all described as "mild sx and positive Ag test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15May2022) Positive, notes: COVID test post vaccination COVID test type post vaccination=Unknown.  Additional information: If Other vaccine in four weeks: No, Adverse event: Travel to withheld and 1 day after return mild sx and + Ag test. If COVID prior vaccination: Unknown. If COVID tested post vaccination: Yes. COVID test post vaccination COVID test type post vaccination: Unknown. COVID test name post vaccination=Home Ag, COVID test date=15May2022, COVID test result=Positive  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available reported information, the causal association between the events vaccination failure and covid-19 and the suspect drug BNT162B2 cannot be excluded.
severe debilitating nausea; she was vomiting so much she went to the ER; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 28Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (dose:1), administration date: 07Mar2021, for COVID-19 immunization. The following information was reported: NAUSEA (non-serious) with onset Mar2021, outcome "unknown", described as "severe debilitating nausea"; VOMITING (non-serious) with onset Mar2021, outcome "unknown", described as "she was vomiting so much she went to the ER". The events "severe debilitating nausea" and "she was vomiting so much she went to the er" required emergency room visit. Therapeutic measures were taken as a result of nausea, vomiting.  Additional information: Female consumer states that she received her 1st dose 07Mar2021, 2nd dose 28Mar2021, and a booster dose 19Dec2021. She reports severe debilitating nausea starting 12 hours after the second dose. States she was vomiting so much she went to the ER. She took Zofran which did not help. They gave her something for the nausea at the ER that did help after a couple hours. States she had to get an IV. 12 hours after the booster dose she had severe nausea and vomiting again and went to the ER again. States it wouldn't stop. States she would like to stay up to date on her vaccines but she is concerned and cant put her body through that every time.  Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300112924 Same patient/vaccine/event, different dose;
thinks maybe the vaccine was administered subcutaneously/not sure if wasn't injected properly; felt water or some liquid going down arm/felt something cold going down arm, like a liquid or water; not sure if she get the vaccine or wasn't injected properly; A spontaneous report was received from a consumer, a female patient of unknown age, who was administered Moderna's COVID-19 vaccine (mRNA-1273) and thinks maybe the vaccine was administered subcutaneously/not sure if wasn't injected properly (incorrect route of product administration), felt water or some liquid going down arm/felt something cold going down arm, like a liquid or water (vaccination site discharge),  and not sure if she get the vaccine or wasn't injected properly  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 30 Jan 2021, prior to the onset of the events, the patient received a dose (not reported whether the first or second of two planned doses) of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.     On 30 Jan 2021, the patient thought maybe the vaccine was administered subcutaneously/not sure if wasn't injected properly and felt water or some liquid going down her arm/felt something cold going down her arm, like a liquid or water.  She was not sure if she got the vaccine.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.    The events, thinks maybe the vaccine was administered subcutaneously/not sure if wasn't injected properly, felt water or some liquid going down arm/felt something cold going down arm, like a liquid or water, and not sure if she get the vaccine or wasn't injected properly were considered resolved on 30 Jan 2021.; Reporter's Comments: This report refers to a case of Incorrect route of Product administration , Vaccination site discharge and Incorrect dose administered for mRNA-1273 , ( lot # unknown).  There were no reported AEs associated with this case of Incorrect route of Product administration , Vaccination site discharge and Incorrect dose administered.
Started having typical side effects of headache three days following date of receiving vaccine. Side effects resolved for two days, then on 9/12/21 she began developing chest pain in upper right area of chest, headache and shortness of breath. Her side effects have not resolved.  She reports she is someone who never gets sick, states the last time she had a fever was in the year of 1991.   She does not have a primary care physician. Has not spoken with a provider concerning her symptoms/side effects. Is concerned about coverage for going outside of network (does not want to see provider at Legacy, is worried it is contradicting after stating she was "forced to take this vaccine" to see a provider).
Patient presents concerned that she may be having an allergic reaction to a vaccine, Patient had a tetanus shot, MMR and varicella vaccine on Wednesday, Last night she started noticing redness, swelling, and itching to the site where she got the varicella vaccine, She has not been running any fever, She was concerned because she is supposed to get a second  vaccine in 4 weeks, She describes the pain to the area as a 1 out of 10..   Patient does present today with redness and swelling to the area where she had her varicella vaccine. She had this on Wednesday. She started noticing the area last night. She was concerned about the possibility of an allergic reaction. Did look on website. It reports that 20% of people get the adverse effect of injection site swelling/rash/pruritus/erythema. 15% will get a fever. I did not think this was an allergic reaction. Also did not think this was a cellulitis. However given the fact that it is Friday and we would be closed the next 2 days, did empirically decide to go ahead and place her on antibiotics. She was given Keflex 4 times a day. She is also instructed to apply warm compresses to the area. She may take either oral antihistamine such as Benadryl or use Benadryl cream to the area for itching. We will bring her back next week for reevaluation to make sure the reaction has improved. She is to return sooner if she develops fever, increasing redness, swelling, pain, worsening symptoms, or any further concerns.
Two days post vaccine #2 injection site became swollen, itchy with rash.  Has lasted four days as of today.
A 65 year old man was treated with OncoTICE. After the third instillation he complained of pain in his penis and a burning with urination, described by the reporter as basic UTI symptoms. Antibiotic( unspecified).
RECEIVED AN UNDILUTED PEDI PFIZER VACCINE. SHE COMPLAINS OF A SORE ARM, HEADACHE AND FEVER OF 101 STARTING TODAY AROUND 2:00PM
Stabbing pain in joints especially leftand right shoulders and right knee, butalso big toes and thumbs; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534), via an unspecified route of administration on 18Mar2021 at 10:00 (at the age of 67-years-old), as a single dose for COVID-19 immunisation. The patient previously, received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202), via an unspecified route of administration to the left arm on 25Feb2021 at 1000, as a single dose for COVID-19 immunisation. Medical history included severe osteoarthritis. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks of the COVID-19 vaccine. Concomitant medications included tramadol (MANUFACTURER UNKNOWN), vicodin (MANUFACTURER UNKNOWN), celebrex (MANUFACTURER UNKNOWN) and cyclobenzaprine (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not tested positive for COVID-19. On 18Mar2021 at 22:00, the patient experienced stabbing pain in joints involving the left and right shoulders, right knee, big toes and thumbs. The patient did not receive any treatment for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event of joint pain was recovered at the time of reporting.   No follow-up attempts are needed. No further information is expected.
PATIENT REPORTS VERY SORE ARM, RASH AND THICKENING OF THE THROAT AFTER RECEIVING SECOND DOSE OF SHINGRIX.  SHE WENT TO URGENT CARE FOR MEDICAL ATTENTION.  SHE REPORTS RECEIVING A STEROID AS TREATMENT.
This spontaneous report was received from an office manager and refers to a 13 month-old patient of unknown gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history reported. On 03-NOV-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with an expiration date on 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. No data logger was involved. This is one of several reports from the same source. Additional information has been requested.
Violent body shaking; Complete loss of appetite; Sour stomach; Nausea; Vomiting; This is a spontaneous report from a contactable consumer, the patient. A 20-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 20Apr2021 at 15:15 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety disorder. 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 COVID vaccine. Concomitant medications included ollie women's multivitamin (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received azithromycin (ZITHROMAX) on an unknown date for an unknown indication and experienced drug allergy. On 20Apr2021 at 16:45, the patient experienced violent body shaking, complete loss of appetite, sour stomach, nausea and vomiting (once). The patient wasn't sure if she needed to consult a doctor. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events violent body shaking, complete loss of appetite, sour stomach, nausea and vomiting (once) were resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
No additional AE reported; A vaccine coordinator reported VARIVAX was administered after a temperature excursion.; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 04-APR-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose and route were not reported; lot # U022320, expiration date: 15-JUL-2023) for prophylaxis (product storage error).         It was reported that the suspect vaccine was exposed to a temperature of minus 11.83 degree Celsius for a time frame of 15 minutes. Previous temperature excursion included 9.37 degree Celsius for a time frame of 2 hours and 30 min.    No additional adverse event (AE) information was provided (no adverse event).  This is one of the multiple cases reported by the same reporter.; Sender's Comments:  US-009507513-2204USA002815:
I WOKE UP SUNDAY MORNING TO PAIN IN MY BACK AND CHEST. I CALLED MY DR THEY WANTED ME TO CALL 911 INSTEAD I DROVE TO THE HOSPITA. THEY STATED SOUNDS LIKE A HEART ATTACK. THEY DID BLOOD TEST AND EKG'S. DIDNT FIND ANYTHING. I AM STILL HAVING PAIN. THEY WANTED ME TO STAY FOR ADD'L TESTING AND I DIDNT. CALLED MY FAMILY DR WILL BE GOING THERE TOMORROW.