chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a healthcare professional concerning a 4 month old patient, of an unknown gender. Medical history and concurrent conditions were not reported. On 10-JUL-2014 the patient was vaccinated with the first dose of ROTATEQ (lot number, expiration date and strength were not reported), 2ml, oral. Co-suspect and concomitant therapies were not reported. The healthcare worker reports that a patient received their first dose of ROTATEQ on 10-JUL-2014 and then accidentally received another dose of 15-JUL-2014. No adverse effect reported. Additional information has been requested.
Hives, red spots on both arms and legs, itchy. Pt taking Claritin and recommended to see PCP.
Sharp pains in her right eye; A numbness in the right side of face; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 23Oct2021 11:00 (Lot number: FF2593) at the age of 70 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Latex" (unspecified if ongoing). Concomitant medication(s) included: LAMOTRIGINE; BUPROPION. Vaccination history included: Bnt162b2 (Dose 1, Single; Batch/Lot No: EP7534; in Arm Right; at 05:00 PM), administration date: Apr2021, when the patient was 69 years old, for COVID-19 immunization; Bnt162b2 (Dose 2, Single; Batch/Lot No: EW0151 in Arm Right; at 05:00 PM), administration date: Apr2021, when the patient was 69 years old, for COVID-19 immunization. The following information was reported: EYE PAIN (non-serious) with onset Oct2021, outcome "not recovered", described as "Sharp pains in her right eye"; HYPOAESTHESIA (non-serious) with onset Oct2021, outcome "not recovered", described as "A numbness in the right side of face". Therapeutic measures were not taken as a result of eye pain, hypoaesthesia. Additional information: Facility where the most recent COVID-19 vaccine was administered reported as Pharmacy or Drug Store. 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. Patient received other medications within two weeks of vaccination. At 11:15 AM, she was experiencing sharp pains in her right eye and numbness in the right side of face. No follow-up attempts are possible. No further information is expected.
There was not an adverse reaction. The situation is the patient was given an expired BUD Covid 19 Booster Vaccine. The BUD was for 02/03/2022 and the vaccine was given to the patient on 02/07/2022.  Patient has been contacted of the information and was advised that the Covid 19 Booster was not valid for the fact of it being expired due to BUD.  The patient wanted to wait on getting the Covid Booster Vaccine at this time.
Patient in for well child check, given 4 vaccines as ordered, parent in agreement. Parent and child leave facility go to birthday party and baby has some frosting and starts vomiting, that when mom notices rash on trunk and face. Return to clinic.
pt recv vax & became pale, skin clammy & then lost consciousness;pt appeared to have seizure x 10sec;pt regained consciousness w/o further difficulty;
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 76-year-old female patient who received SHINGRIX (batch number 5NY3B, expiry date unknown). Previously administered products included Shingles vaccine (In 2012, the patient received original Shingles vaccine). Concurrent medical conditions included blood pressure high. On 30th April 2018 10:30, the patient received the 1st dose of SHINGRIX. On 30th April 2018, 2 hrs after receiving SHINGRIX, the patient experienced injection site pain and injected limb mobility decreased. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were not recovered/not resolved. The reporter considered the injection site pain and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: Concomitant medication included high blood pressure medications. The patient received SHINGRIX on the left arm. The patient experienced pain at injection site which described as going from elbow to shoulder and due to pain, the patient was unable to lift arm. The patient had denied permission to contact their physician.
sore red hot arm, that appeared 24 hours for 3 days, went away then reappeared 7 days later that increased in size with itching and hot to the touch, painful that kept growing in size. Went to UR care and instructed to place heat on and off. went away about 2 weeks later
Rash, Purpura, "Spotty skin discoloration (slight reddish/purple color) down the arm L > R, Pain at injection site"
12 hours after injection, had fever, short breathing, malaise and fatigue that lasted 16 hours and required two doses of ibuprofen for the fever
This child received the vax in either November or December 1998. Eight to nine months post one dose of varicella virus vaccine live, on 08/25/99, the pt experienced clinical varicella with greater than 50 papulovesicular lesions with oozing. The pt was afebrile. The pt sought unspecified medical treatment. Additionally the pharmacist noted that his other child experienced a similar reaction.  Additional information has been requested.
Patient developed diarrhea on Tuesday after receiving shot on Monday (7/17/17). Still having issues with diarrhea.
10 days after receiving the vaccine, presented with  rash on lower legs, fever, chills, night sweats, muscle & joint pain. ER treated me for cellulitis although results of blood work,  etc which came back after diagnosis did not show anything wrong. IV steroids, antibiotics, Tylenol at ER & oral steroids/antibiotics 5 days following. Rash gone the next day and fever broke that night. Symptoms except rash returned immediately once discontinued medication 5 days later and have persisted for the past 5 days with fever as high as 104.8. Re-read my Moderna material wondering if anything in the vaccine could be causing it and was told adverse reaction can appear as much as 3 weeks later and that symptoms I had were common.
full chrons symptoms; Joint pain; This spontaneous case was reported by a physician and describes the occurrence of CROHN'S DISEASE (full chrons symptoms) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    Concurrent medical conditions included Crohn's disease (moderate to severe).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced CROHN'S DISEASE (full chrons symptoms) (seriousness criterion medically significant) and ARTHRALGIA (Joint pain). At the time of the report, CROHN'S DISEASE (full chrons symptoms) and ARTHRALGIA (Joint pain) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 (Moderna COVID-19 Vaccine); therefore, the action taken in response to the events was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
No additional adverse effects were reported; temperature excursion for PNEUMOVAX (syringe) which was administered to a patient; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.   On 17-FEB-2021, the patient was vaccinated with an improperly stored dose of pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) lot# T035379, expiration date reported as 31-MAY-2022, for prophylaxis (strength, dose, route and frequency were not reported).  The temperature excursion and the reported time frame was below 36 Fahrenheit degrees (°F) (31.5°F), for 10 hours 0 minutes and 0 seconds. There was no previous temperature excursion. A digital data logger was involved. No additional adverse effects were reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T035379; expirationdate: 31-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Patient experiences substernal chest pain, pressure-like sensation, shortness of breath, associated with diaphoresis and nausea.  These symptoms occurred in less than 1 week after first covid vaccine (mfg unknown). Patient is admitted to hospital with a cardiology consult..  Patient is treated with ibuprofen and metoprolol succinate 25mg daily.  At discharge, patient is instructed to refrain from any further covid vaccine doses.
A territory representative reported that an 18 month old child received an injection of Acel-Immune vaccine. The child was receiving Tobrex for treatment of conjunctivitis at the time of immunization. On 5/25/00, the child developed an injection site reaction characterized by a 13cm by 9cm area of swelling and redness.
The patient had a 7cm x 7cm swollen circular area to his right deltoid that was red and warm to the touch. The patient complained of itching and pain when touched.
Received a booster dose beyond the use date (beyond 30 days at 2-8C).BUD: 12/28/21. Notified manufacturer Moderna & Immunize Manager.
Itchy rash appeared at site of injection 8 days after vaccination.  Rash was approximately 4 inches in length and 2 inches wide.  Warm to the touch, a little sore and muscle is a bit rigid. Rash spread a bit the 2nd day but is about the same side and itchiness today (day 3).
Itching all over, then development of rash, on trunk then spread to extremities.  On exam 11/27, rash most consistent with PLEVA.
flu-like symptoms; This is a spontaneous report from a contactable Other Health Professional via sales representative. A 7-decade-old female patient received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced flu-like symptoms following second dose of Pfizer COVID 19 vaccine. Medical staff advised her to take acetaminophen. Outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
L arm - FLu, pain from top of shoulder down to elbow  R arm - Prevnar, moderate pain from top of shoulder down & sharp pain
Localized, swelling, warmth & itching; d/c last dose & will do titer check;
13apr90 and 09may90 pt vax hepta B. each time pt ex numbness and pain in the left side of face. tx included pres/drug therapy.
On the consent form signed by the patient, patient marked the answer "No" to question 4 that asks if patient has ever received  a dose of Covid - 19. Patient was given Moderna 1st dose, as requested, but when billing we discovered patient was given a dose of Janssen Covid - 19 vaccine on April 7, 2021
Pain and swelling to joints specifically the sides of both knees, hands, and feet. Redness and warm to the touch on the sides of both knees.
After dose 4 I tested positive for COVID-19 in September of 2022. I had a fever and felt really bad with fatigue. My symptoms last about 5 days. After dose 5 I tested positive for COVID-19 in March of 2023. I had fever and fatigue; sinus congestion and sore throat and I developed a cough. I took PAXLOVID with each infection. As of today, I still have a cough and sinus issues.
Dizziness, HYPOtension, sweats, "feeling like I was going to pass out" Narrative:
suspected Vaccination failure; Shingles bother the skin tissue; five days that I could not walk without a cane; very debilitating; shingles affect the nerves; bother the skin tissue; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (experienced first outbreak 34 years ago).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, walking difficulty, debility, neuralgia and skin disorder. On an unknown date, the outcome of the vaccination failure, shingles, walking difficulty, debility, neuralgia and skin disorder were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, walking difficulty, debility, neuralgia and skin disorder to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient stated that the shingles were horrible. The patient had first break up was 34 years ago. The patient took a daily medication that suppresses them. Missing one day of medications was bad.  The patient had both vaccines. The stated that he/she did not believe those work because his/her doctor said stop taking the medications because he/she had the vaccine. And physician would not give a new script until he/she was reevaluated which got to the point of five days that the patient could not walk without a cane. Very debilitating. The patient reported that the shingles not only bother the skin tissue but worse they affect the nerves. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles not reported.
Tiredness, muscle pain, headache, shivering, fever, nausea. Ibuprofen 800mg. Stayed resting. Effects resolved by 05/07/2021 pm
fast heart beat, dizziness, weakness, hypothermia,joins and bones ache and headache
10/7 - visited Center, arm red and warm, treated with Ibuprofen.  11/9 - saw PCP, arm red, swollen, hot around injection site, patient says hurt to raise arm; dx'd as cellulitis?, treated with Abx.  10/15 - patient doing well, residual redness remains.
Right arm tingling. Patient reports it has been going on and off all day on 10/3/23.  Tingling from right mid bicep down to both sides of hands. No other symptoms.
102.8 fever; Chills; Nausea; This is a spontaneous report from a non-contactable consumer, the patient. An adolescent non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an unspecified route of administration on 08Jun2021 at 08:00 as a single dose for COVID-19 immunisation. The patients' medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. On an unknown date in Jun2021, the patient experienced fever 102.8 (unspecified units), chills and nausea. The events did not result in doctor or other health care professional office/clinic visit, and 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 fever 102.8 (unspecified units), chills and nausea were unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Patient had increase in heart rate, blood pressure was 182/110, vomiting, and severe cephalgia. Patient was at ER at 9:30 to 4:00. Patient was administered IV, meds for blood pressure, and a shot of morphine and Phenegran. Patient left feeling better. No other symptoms since then.
This spontaneous report as received from a pharmacy technician refers to a 4-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and, concomitant medications were not reported. On 14-MAR-2018 the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry date: 23-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA001558.
Experienced menopause in 2018, no menstrual cycle since. Full cycle came after receiving vaccination.
No  Adverse events.  Patient received monovalent Pfizer as a booster instead of bivalent.   I  notified the patient vaccinated with the Pfizer Monovalent instead of the Pfizer Bivalent booster about the mix-up.  I informed them that received the monovalent instead of the bivalent booster.  I provided assurance that there are no safety issues with the vaccination they received today.  I informed them that the Pfizer monovalent vaccine is still used as a first and second COVID vaccine and was previously used as a booster.  I informed them that the monovalent dose they received today would not give them the full range of coverage of the current bivalent dose.  I advised them in 2 months; they will be able to receive the Pfizer Bivalent Booster if they wish.  I answered all questions.
7/3/12 - Rash fine red clusters, lower back. Fussy, clingy to mother. Fever of 100 with TYLENOL 7/10 - still has rash, fever - mostly rash resolved now. Has a couple red spots on leg from injection site., fever 100.4.
My heart started beating very hard and would not slow down as I was loading kids in the car to school. It was so bad i ended up flagging my sister in law to bring me to the hospital. When i got there my hear was beating over 200 beats a minute. To slow it down they used Adenosine 2 doses. the Cardiologists said this was a reaction from inflammation in my body due to the vaccine.  I continued to have aggresive heart palpatations 2 weeks or more after.
Discharge dx: fever secondary to IZ. Discharge meds: tylenol prn. Approx 3-4 hours after receiving vaccines developed fever and brought to the ER with some irritability. Given a shot of IM Rocephin because of concern over possible sepsis.
joint and muscle ache and pain in arms, legs and buttocks began to be noticeable February 21, 2021; joint and muscle ache and pain in arms, legs and buttocks began to be noticeable February 21, 2021; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 71-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9266) via an unspecified route of administration at arm left on 16Feb2021 13:00 as single dose for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. Medical history included prostatic disorder, Rx control for prostate and cholesterol, blood cholesterol abnormal. Concomitant medications included finasteride (FINASTERIDE) and rosuvastatin (ROSUVASTATIN). On 21Feb2021 the patient experienced joint and muscle ache and pain in arms, legs and buttocks began 07:00 and has been escalating each day since then, the aches and pain are becoming unbearable while moving, or walking. The outcome of the event aches and pain are becoming unbearable while moving, or walking was unknown and rest events was not recovered.
Arm had big round circle that was hard and hot; Arm had big round circle that was hard and hot; A spontaneous report was received from a consumer concerning a 66-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm had big round circle that was hard/ vaccination site induration, and hot/ vaccination site warmth  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 28 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection. On 25 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events arm had big round circle that was hard and hot. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events Arm had big round circle that was hard and hot was unknown.
PATIENT HAS HAD BLOTCHED SKIN RASH ON THE ARM OF THE INJECTION SITE AND SHORTNESS OF BREATH. PATIENT NOTICED THIS THE DAY AFTER AND IT IS STILL LINGERING. PATIENT STARTED A HEADACHE THREE DAYS AGO.
Information has been received from a Registered Nurse, via a company representative, referring to a 71 year old female patient. The patient did not have medical history, concurrent conditions or concomitant therapies. On an unspecified date in September 2017 (also reported as "in the last 2 weeks"), the patient was vaccinated with a dose of PNEUMOVAX 23 lot # N011305, expiration date of 20-JAN-2019, intramuscularly (dose, anatomical location and expiration date were not reported) for prophylaxis. On an unknown date in September 2017 (reported as "within a day of receiving the vaccine"), the patient developed cellulitis. The reporting registered nurse stated that on an unspecified date, the patient was examined and treated with unspecified antibiotics at the facility. The outcome of the cellulitis was reported as recovering and the causality between the vaccination with and the event was not reported. Upon internal review, the cellulitis was considered as a medically significant event. This is one of several reports received from the same source. Sender's Comments: US-009507513-1710USA001897: US-009507513-1710USA001898.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with the dose of GARDASIL (dose, route, lot # and expiration date were not reported). On 21-SEP-2016, the patient was vaccinated with the dose of GARDASIL 9 (dose, route, lot # and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
Occasional chest pain, occasional rapid heartbeat, occasional shortness of breath -- intermittent but persistent