chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reported for second dose of Pfizer Covid19 vaccine today. He reported have hand, foot and mouth virus about 3 days after 1st dose of vaccine. His daycare aged daughter was exposed and had an outbreak as well. Wife and other child showed no symptoms. He had a fever on day 3 post vaccine and blisters appeared on day 4. He was told by another health care professional that he may have been "compromised" by the first dose of vaccine and therefore vulnerable to contracting hand, foot and mouth from daughter. He was unable to stand on feet for 3 days and showed me photos of his legs. His hands are also still peeling/recovering today.
Moderna COVID-19 Vaccine EUA Vaccination site soreness developed shortly after vaccination.  By around 6-8pm (~7-9 hrs post vaccination), a firm, round, knot was palpable at the vaccination site and the skin was red, blotchy and hot to the touch.  Pain had intensified and the arm could not be touched.  The following 24 hrs, pain intensified and was about a 6/10.  The swollen, red knot was larger and still very hot to the touch.  Pt could not ice the area because any amount of pressure was unbearable.  At 48 hrs, the pain was lessened, but the red, swollen knot remained.  By 48-72 hrs post-vaccination, the pain was gone but the swollen knot and red skin/rash-like area was itchy.  The itchiness persisted and is still present 8 days later.  Tylenol was taken the day of vaccination but had no effect.  Topical anti-inflammatories (Voltaron and CBD rub) were used at different times and also had no effect.
She also experienced shortness of breath/out of breath; heart out of sync; new heart rhythm abnormality; she has heart rhythm problem (premature atrial contraction); feeling exhausted; This is a spontaneous report from a contactable Nurse (patient). A 61 -year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL3249), via an unspecified route of administration on 19Jan2021 (at the age of 61 -years-old), single dose for COVID-19 immunization. Medical history included covid infection over a year ago. The patient had no concomitant medicines were not reported. The patient She had flare ups when she took Hep b vaccine before and did not get the 2 remaining doses because of the reaction. She has had so many vaccines over the years and had her flu shot every year. Patient had the 1st dose of the PFIZER-BIONTECH COVID-19 VACCINE last 19Jan2021. Consulted the doctor 01Feb and told she has heart rhythm problem (premature atrial contraction). She also experienced shortness of breath. Not sure if it is vaccine related or due to her age. She will have the 2nd dose on 09Feb2021. Stated that she was feeling exhausted (29Jan2021) and out of breath. Stated that the doctor told her that her heart rhythm out of sync. Stated that in Dec she had her heart checked and it was okay. Stated that her other Covid is due to be given 09Feb. Does not know if the vaccine is contributing to her heart rate's bivalvular rhythm. Stated that she had Covid infection over a year ago. Stated that she is worried that the vaccine caused an abnormal rhythm to her heart. Stated that she has a new heart rhythm abnormality. Stated that she had all of her lab work done on 11Jan2021 and it was okay. Stated that on 27Jan-28Jan that she tried to pick up a watermelon and was short of breath for no reason. Stated that it happened a couple of times. Stated with her rhythm being out of sync that it feels like her heart is failing. The outcome of the event dyspnea was recovered, heart disorder and fatigue was not recovered, other events was unknown.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported arrhythmia cannot be excluded.  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.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (arm is so huge and so swollen), HEART RATE INCREASED (heart started acting up/beating erratic like) and HEART RATE IRREGULAR (beating erratic-like) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (Patient is allergic to dairy products) and Allergy to chemicals (Patient is allergic to Bactrim). Concomitant products included ZINC for an unknown indication.  On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 27-Feb-2021, the patient experienced VACCINATION SITE SWELLING (arm is so huge and so swollen), HEART RATE INCREASED (heart started acting up/beating erratic like) and HEART RATE IRREGULAR (beating erratic-like).   On 01-Mar-2021, HEART RATE INCREASED (heart started acting up/beating erratic like) and HEART RATE IRREGULAR (beating erratic-like) had resolved. At the time of the report, VACCINATION SITE SWELLING (arm is so huge and so swollen) outcome was unknown.      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.   Patient's treatment medication included Heart pill taken half a pill to make sure that heart beats right and hot compress on the injection site.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Patient sick, declined further FU
Seizures; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 19 year-old female 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: SEIZURE (medically significant), outcome "unknown", described as "Seizures". Patient's mother reported that she had a question about an adverse event that her daughter had seizures after vaccination. Reporter was not sure that adverse event was from the vaccine and her daughter would be going to the doctor for an evaluation.   The lot number for bnt162b2 was not provided and will be requested during follow up.
I want to report that within a day or two of receiving  my first injection of Shingrix, in addition to right arm pain and soreness at the injection site and general lethargy the first day after, I DEVELOPED A NOTICEABLE SWELLING OF LYMTH NODE IN RIGHT ARMPIT THE SIZE OF AN ORANGE WHICH WAS EXTREMELY PAINFUL WHEN PRESSED. THE SWELLING WOKE ME FROM SLEEP THE SECOND NIGHT AFTER  INJECTION. I HAVE HAD AN ULTRASOUND OF MY RIGHT ARMPIT YESTERDAY 01/14/2020 which confirms the enlarged lymph glands.  Some swelling and soreness of my armpit still remains. I AM CONCERNED ABOUT TAKING THE SECOND DOSE OF SHINGRIX.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 26-JAN-2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy for routine health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster (onset date unknown). Shortly after receiving the ZOSTAVAX, the patient developed bulging veins, along with bulging temples and swelling arms. Thereafter, the patient was diagnosed with giant cell arteritis. The outcome of the giant cell arteritis and swelling arms is unknown. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Information has been received from a pharmacist concerning a 12 month old female pt with inner ear infection on the day of vaccination and conjunctivitis a short time prior to vaccination, who on 19Apr05 was vaccinated with 0.5mL dose of varicella virus vaccine live. Concomitant therapy administered on 19Apr05 included tuberculin purified protein derivative and amoxicillin/clavulanate potassium (Augmentin) started on 19Apr05 for her inner ear infection. The pharmacist reporter was unsure if measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) was also administered on that same day, 19Apr05. It was noted that a week to 10 days later on approx 26Apr05, the pt developed a high fever of 102. After a day or two the fever broke and was followed by generalized red speckled rash and no lesions. No outcome was reported for the red speckled rash. There were no lab or diagnostic tests performed. There was no product quality complaint reported. Unspecified medical attention was sought by the pt. Additional information has been requested.
High temp about 6 hours after after injection, Enlarged lymph nodes in groin and armpit (red), severe HA couldn't walk for approx 6-8 hours after legs felt very heavy for 2 days.
Received Zostavax Vaccine on 12/4/2006 and developed shingles on the right side of abdomen in dermatome distribution with burning and continued pain. Diagnosed by Internist, and a dermatologist. Started Valtrex one gram TID 36 hrs post lesions appearing and received Kenalog IM on 2/21/07 by doctor. Lesions now starting to heal.
Large area of redness where vaccine was administered also raised rash (circle like) on area of vaccine administration. After 4 days rash still there and is itchy.
Reaction to second vaccine (7/10/2021) -Vomiting  -Fever for 24 hours -Pain; on vaccine site, entire right arm and right side of back Took 4 doses of Tylenol (every 6 hours)
At 8:45am, I woke up with a tight pain in my chest on the left side and pain in my left arm, left side of neck and left ear. The pain was severe enough that I considered going to the hospital because I thought I was having a heart attack, but decided not to because I am a healthy and fit 27year old. The pain got more severe. I alternated between laying down while struggling to take deep breaths and stretching because my left neck and arm hurt. I drank about 16oz of water. At around 11am I threw up water. At around 12pm I was able to fall back asleep. When I woke up around 1:30pm I felt much better with just very mild symptoms and by about 4pm I felt completely better. I have had no symptoms since.
aches; accidentally gave my wife 2 doses of Spikevax in the left arm on 10OCT2023; headache; tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches), ACCIDENTAL OVERDOSE (accidentally gave my wife 2 doses of Spikevax in the left arm on 10OCT2023), HEADACHE (headache) and FATIGUE (tired) in a 75-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch nos. ASKU and ASKU) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Wife is Healthy on Medications: Lisinopril, Jardiance, Glipizide, and Lifibrol She does not have liver disease.  Concomitant products included LISINOPRIL, EMPAGLIFLOZIN (JARDIANCE), GLIPIZIDE and LIFIBROL for an unknown indication.   On 10-Oct-2023, the patient received first dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 10-Oct-2023, received second dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (aches), ACCIDENTAL OVERDOSE (accidentally gave my wife 2 doses of Spikevax in the left arm on 10OCT2023), HEADACHE (headache) and FATIGUE (tired). At the time of the report, PAIN (aches) and HEADACHE (headache) had not resolved and ACCIDENTAL OVERDOSE (accidentally gave my wife 2 doses of Spikevax in the left arm on 10OCT2023) and FATIGUE (tired) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   PAtient had FLU Shot 1 month prior to Spikevax.   This case was linked to US-MODERNATX, INC.-MOD-2023-745305 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745305:Husband's case
After receiving the Moderna vaccination I starting to experience chills, I also experienced trouble swallowing and developed a sore throat. My symptoms also advanced to sinus drainage and it lasted for 24 hours. I tested myself for COVID and came up positive. I visited the local clinic and consulted with them and confirmed a positive case of COVID.
Moderate swelling of area where shot was given, redness, tingling, aching and numbness in fingers and elbow, aching in armpit, pain.
Janssen COVID-19 Vaccine EUA almost immediate, ongoing fever, chills, body aches, stuffy nose mild relief with ibuprofen
How long can the side effcts last; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (How long can the side effcts last) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (How long can the side effcts last). At the time of the report, VACCINATION COMPLICATION (How long can the side effcts last) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported . No treatment medication was reported .   Reporter did not allow further contact
The rash looks like erthema multiforme, with no oral lesions, or skin peeling; Patient developed a delayed rash from her neck down throughout her body; Allergic reaction; This spontaneous case was reported by a physician and describes the occurrence of ERYTHEMA MULTIFORME (The rash looks like erthema multiforme, with no oral lesions, or skin peeling) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced ERYTHEMA MULTIFORME (The rash looks like erthema multiforme, with no oral lesions, or skin peeling) (seriousness criterion medically significant), RASH (Patient developed a delayed rash from her neck down throughout her body) and HYPERSENSITIVITY (Allergic reaction). At the time of the report, ERYTHEMA MULTIFORME (The rash looks like erthema multiforme, with no oral lesions, or skin peeling), RASH (Patient developed a delayed rash from her neck down throughout her body) and HYPERSENSITIVITY (Allergic reaction) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was provided.  Company Comment: This case concerns a 76-year-old, female patient with no relevant medical history, who experienced the unexpected, serious AESI of erythema multiforme and other associated expected, non-serious events. The events occurred 4 days after administration of the booster dose of the Moderna mRNA-1273. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Follow up document contains new serious event, dose details, reporter details and patient details were updated.; Sender's Comments: This case concerns a 76-year-old, female patient with no relevant medical history, who experienced the unexpected, serious AESI of erythema multiforme and other associated expected, non-serious events. The events occurred 4 days after administration of the booster dose of the Moderna mRNA-1273. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna mRNA-1273 is not affected by this report.
1. Diarrhea started at 7pm the following day 2. Itchy skin rash on neck, chest, back noticed 48 hours after injection
When it started, I felt like it was just a cold with sinus congestion. It then went into my lungs, and I began bringing up phlegm. I had a telehealth visit with my doctor in December 2022, who prescribed me prednisone and an antibiotic whose name I don't recall. My symptoms did not improve after I took those. I saw my doctor again later in January 2023. She gave me prednisone to take three times a day, but she didn't give me an antibiotic. However, she did change my inhaler from QVAR to TRELEGY. Then the phlegm production eventually stopped, but I then had coughing and wheezing. While I was having these symptoms, all through December 2022, January 2023, and February 2023, I had to frequently use my albuterol rescue inhaler, because I would gasp for air and had wheezing and tightness in the chest. In January 2023, she also gave me benzonatate capsules for the cough. She then ordered the lung X-ray, which indicated that my lungs were clear. When I saw my doctor in February 2023, she prescribed me TRELEGY, a third batch of prednisone, and SINGULAIR. She has also referred me to a pulmonologist, whom I'm due to see in the near future. At the time of this writing, I feel that my breathing has improved and that I have to use my rescue inhaler less often during the day. However, I do use the rescue inhaler more at night than during the daytime. Although my breathing is now better, I still have hoarseness.
L arm with swelling & redness 12.5 cm x 14.5 cm around site of Varivax injection.
had developed chickenpox; This case was reported by a pharmacist via call center representative and described the occurrence of chickenpox in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th July 2020, the patient received the 1st dose of Shingrix. On 17th August 2020, 19 days after receiving Shingrix, the patient experienced chickenpox. On 19th August 2020, the outcome of the chickenpox was recovered/resolved.   It was unknown if the reporter considered the chickenpox to be related to Shingrix.  Additional details were provided as follows: It was reported that the patient had developed chickenpox in the last few days (17th August 2020-19th August 2020) after getting the Shingrix vaccine. The patient did not consent to follow-up.
Suspected vaccination failure; flare ups of shingles; This case was reported by a other health professional via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, 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 Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient asked for the reason for getting flare ups of shingles even though the patient received Shingrix. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for herpes zoster were not provided.
Syncopal event he has had this occur in the past with every vaccine- he was administered the vaccines while lying on the exam table- he did initially pass out- feel nauseous- seemed ok after 5 minutes and tried to sit up only to become dizzy again and need to lie down- he was given ice pack- ammonia inhalant used x 1- he had several attempts at sitting up but became dizzy and nauseous- needed to lie down- he tried to drink orange juice and then some gatorade- vomited a small amt after sleeping for 20 minutes he finally felt well enough to stand, walk and go home total time at least 60 minutes from vaccine administration until he was able to walk out the door
Myocarditis after 3rd dose of vaccine on May 20, 2022. Previous doses completed on May 27, 2021 and June 17 2021.  Woke up on May 23, 2022 morning with chest pain, nausea, generally feeling weak. Brough to ER at local hospital and noted to have six beat run of ventircular tachycardia. Also had elevated troponin I to 7.1 ng/mL. Admitted to alternate Hospital, on 5/23 for monitoring. Troponin monitoring. Did not develop any further complications. Did receive IVIG due to diagnosis of myocarditis by cardiology. Seen by Pediatric infectious diseases. Discharged to home on 5/26/22.
from knee up on lt leg was swollen, had a screaming episode that lasted 3 hrs, fever low grade 101;
Joint inflammation began on day 2 after the shot (COVID dose #1). I supported with daily acupuncture treatments as per rheumatologist advice, with gradual worsening of symptoms. By day 5 it was clear the inflammation was progressing and I curtailed the recommended medication hold on my biologic. By day 8 it was clear I was flaring with systemic inflammation, accompanied by fatigue. I did not do the medication hold for dose 2, per the rheumatologist; but did do the dose at the optimal 3 week interval.  The flare is continuing, now 2 months after it began. It is gradually decreasing in intensity. To be clear, this is after a 5 year very solid remission.  It is impossible to tease out whether the vaccine or the medication hold is the causative factor; but the hold was a requirement for the vaccine per my rheumatologist.
PATIENT SAYS SHE EXPERIENCED NAUSEA/VOMITING, MUSCLE ACHES, SYMPTOMS OF A CHEST COLD ,CHILLS  AND ARM PAIN AT INJECTION SITE APPROXIMATELY 2 HOURS AFTER RECEIVING THE VACCINE. IT IS UNKNOWN IF SHE HAD A FEVER, SHE FELT TOO TERRIBLE TO GET OUT OF BED TO CHECK.
Fever blisters all over his lips; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (Fever blisters all over his lips) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ORAL HERPES (Fever blisters all over his lips). At the time of the report, ORAL HERPES (Fever blisters all over his lips) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  The patient had some kind of imbalance occurs in body.  No treatment information was provided.
Edema from mid thigh to knee, decreased weight bearing, pain with walking, fever up to 101.