chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HEART INFLAMED; ENLARGED HEART; This spontaneous report received from a consumer concerned a 53 year old female with unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on SEP-2021 for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported.  No adverse event reported after primary vaccination (dose number in series 1). The patient received additional non-company suspect vaccine Pfizer biontech covid 19 vaccine (tozinameran) (dose number in series 2)  ( form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered on 22-MAR-2022 for prophylactic vaccination.  On an unspecified date following vaccination with Pfizer biontech covid 19 vaccine, the patient experienced enlarged heart, and heart inflamed. The patient was put on a heart monitor. The patient underwent tons of tests, CT scans, bloodwork, EKGs (electrocardiogram), 14 tests that have came back (results unspecified). The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The outcome of the enlarged heart and heart inflamed was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220409107-covid-19 vaccine ad26.cov2.s-Heart inflamed. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 81-year-old female patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, immediately after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling, muscle pain, arthralgia, pain in arm, skin bleeding, general body pain, tiredness, bruising of arm, activities of daily living impaired and loss of energy. On an unknown date, the outcome of the injection site erythema, injection site swelling, muscle pain, arthralgia, pain in arm, general body pain, tiredness, bruising of arm, activities of daily living impaired and loss of energy were recovering/resolving and the outcome of the skin bleeding was unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling, muscle pain, arthralgia, pain in arm, skin bleeding, general body pain, tiredness, bruising of arm, activities of daily living impaired and loss of energy to be related to SHINGRIX. Additional information was reported as follows: The patient stated that, right after the vaccination, she experienced sore muscles and joints, injection site redness and swelling and this continued following the first week after the vaccination. The patient stated that, the soreness and muscle pain in the injected arm was so bad that she could not turn the keys to even start her car, lift up a cup of coffee or even vacuum her floors. The patient was unable to do the tasks which she usually could do. The soreness and pain traveled down to her right hip to the left hip and further followed up her left arm. She said it was like the soreness and pain was traveling across her body. The patient's daughter noticed that she saw bruising on patient's arm. The bruises looked more like blood running under the skin. It looked like streaks running down her arms and legs. The patient also stated that, the weird thing was that the bruising was down her right arm and left calf on her leg. Less than a month after the vaccination the patient experienced streaks running down her arms and legs, soreness across the body, tiredness, bruising on arm, unable to do tasks the patient usually could do and no energy to do anything. She could not make sense of what was happening to her. She was still experiencing the adverse effects till the time of reporting; however, they had started resolving at the time of reporting. At the time of reporting, the soreness and bruising were almost gone in her right arm and the left arm was getting better and the side effects in her right hip were not as bad as the left hip. The patient also stated that, all this went for a period of about 3 weeks. At the time of reporting, she still felt tired and had no energy to do anything. She had not contacted her physician. The patient could not remember the exact dates of vaccination and the event onset dates. The patient stated that she would not be getting the second dose of SHINGRIX.
Tdap, MENACTRA, FLUMIST administered approx 930am. Developed HA, neck pain, and extreme fatigue within 1-2 hours. Returned to our office 1 pm, taken to ER by ambulance. Treated with IV fluids. Recovered by 6 pm.
I hear loud ?Crickets ? all the time. My hearing seems deminished. Toes hurt. I have wheezing. I have dizziness.
april 7, extreme skin tingling all over, only lasted that one night april 12, noticed increased tinnitis, I already had it and it is now louder
Fever; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PYREXIA (Fever ) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included Paraneoplastic syndrome and Cancer. Concurrent medical conditions included Blood pressure and Cholesterol. Concomitant products included SIMVASTATIN for Cholesterol, LISINOPRIL for Hypertension, Durvalumab.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PYREXIA (Fever ). On 16-Jan-2021, PYREXIA (Fever ) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Body temperature: 101.7. On 15-Jan-2021, Body temperature: 101.1. On 16-Jan-2021, Body temperature: 99.9.     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.
This spontaneous report as received from a physician refers to a female patient of unknown age. On 17-JAN-2013 the patient was vaccinated with VARIVAX (merck) (lot number not provided) dose 1. On 31-JAN-2013, two weeks after receiving the vaccine, the patient developed chickenpox. She had multiple lesions on her face and body. The patient was treated with acyclovir. On an unknown date in 2013 the patient recovered. The relatedness for chickenpox was not provided. Additional information is not expected.
Seriousness Criteria: Other - Medically Significant (OMIC). Initial report received from a literature citation on 27/Feb/2006. A 55 year old male patient with no reported medical history had received tetanus/diphtheria toxoid, hepatitis A and typhoid vaccinations on an unspecified date in preparation for a trip. The trade names, manufacturers and lot numbers were not reported for any of the products. Seven days post-vaccination the patient noted episodes of shooting pain in the right occipital region, superior and posterior to the right ear and rarely in the right anterior neck. Each attack of pain lasted one to two seconds. Initially the pain was mild, but over the next three day, it increased in severity and frequency. The maximum frequency was ten to 20 attacks per hours. The pain was eventually rated eight of ten in severity. There were no cranial autonomic features. Touching or turning the head did not trigger the pain, and there was no Lhermitte sign. After seven days, the shooting pain resolved. Following this, the patient had mild tenderness in the right occipital region for a few days. He had been pain-free for eight days at the time of neurologic consultation. His neurologic examination was normal aside from decreased pain and temperature sensation in a small area posterior to the right ear. Occipital nerve tenderness was absent, and there were no occipital skin lesions. MRI of the brain with gadolinium was normal. MRI of the cervical spine nine days after the shooting pain ended revealed a small area of increased T2 signal in the central spinal cord at the C2 level. The lesion showed contrast enhancement. The following tests were normal; sedimentation rate, B12, vitamin E, Folate angiotensin converting enzyme, myeloperoxidase, proteinase, antinuclear antibody, anti-DS-DNA, antibody to extractable nuclear antigen, comprehensive paraneoplastic panel, Lyme screen, and syphilis serology. Spinal fluid examination was normal aside from a mildly elevated protein of 54 mg/dL. The CSF IgG index was normal, and the synthesis rate was zero. There was one oligoclonal band (within normal limits), and CSF cytology was normal. A chest radiography revealed a calcified granuloma at the left apex. The patient remained pain-free in the following months. Follow-up MRI ten weeks later showed resolution of the abnormal signal and enhancement within the cervical spinal cord. The patient had spontaneous remission of pain. The impression was that the patient demonstrated a clinically isolated syndrome of C2 myelitis.
testing positive on a rapid test; testing positive on a rapid test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Feb2021 as dose 1, single (Lot number: El9269), on 27Feb2021 as dose 2, single (Lot number: EN6202) and on 16Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 years for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "Penicillin Allergy" (unspecified if ongoing), notes: Penicillin Allergy. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Apr2022, outcome "not recovered" and all described as "testing positive on a rapid test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Apr2022) Positive; (07May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information -It was reported that on Day 10 since testing positive for Covid and still testing positive on a rapid test. Patient tested positive on 28Apr (Day 0) and started Paxlovid the same day. She completed her Paxlovid prescription on 02May (Day 4). Her symptoms improved and were completely resolved after a few days. Yesterday her symptoms returned. They are more mild this time. But the rapid test is bright line pink positive immediately after applying the solution   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Vaccine #1: Supraclavicular lymph node swollen couple of hours after injection. 8 Hours after vaccine, chills, body ache, stiffness of left arm, and fatigue. Itchy rash around injection site 8 days later.  Vaccine #2: 8- 10 hours after injection, chills, body ache, stiffness of left arm, headache, fatigue, and fever (100-101.5 degrees). 24 hours later, Swollen lymph node, fever, chills headache, and fatigue. Rash around the injection site3 days later. 6 days later, swollen lymph node (slightly reduced)
Patient received 1st dose of Pfizer covid vaccine and was told to stay 15 minutes after vaccine was administered to monitor for symptoms. We were then informed she fainted at the front of the store. It was reported she was unconscious for roughly 30 seconds. When I came up to her, she was conscious on sitting on the floor.  She was given cold water and an ice pack while EMTs were on their way.
Same day post vax, the pt developed an injection site reaction characterized by an area of redness, edema, and hardness the size of a grapefruit. The pt reportedly could not move the affected arm.
Primary Care Physician at Discharge:  MD   Hematologist/Oncologist: Dr.   Admission Date: 6/6/2023 Discharge Date: 06/10/2023  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Neutropenic fever [D70.9, R50.81] Pneumonia due to COVID-19 virus [U07.1, J12.82]   DISCHARGE PROBLEM: COVID 19 Pneumonia  CLL AFIB Warm autoimmune hemolytic anemia Left atrial appendage device closure   PRESENTING COURSE: Patient is a 70 y.o. patient with a past medical history significant for warm hemolytic anemia, afib, chronic BLE swelling, and CLL currently on treatment with Gazyva and Venetoclax who presented to Health ED for symptoms of fever x 1 week and cough x 2 weeks. The patient started to not feel well on 5/20. He took a home Covid test and was positive on 5/23.    HOSPITAL COURSE: Patient was admitted and started on IV Remdesivir in which he completed 5 days. He did require supplemental oxygen and was set up for home oxygen as well. He continued to improve and felt well enough to discharge home today with plans to complete 5 days of Paxlovid and 10 days of dexamethasone. He will hold his Venclexta while taking Paxlovid and will discuss restarting at follow up. He was educated on when to call with questions or concerns. He is stable and ready for discharge
Muscle spasms on left side of body (arm, shoulder, leg, face). The muscle spasms are worse in the arm. The spasms are only on the left side of the body. The spasms were worst the night of the vaccine and they have improved, however the spasms are still present.
Active shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient had active shingles after first vaccination of Shingrix.
afib; fast heartbeat; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (afib) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced ATRIAL FIBRILLATION (afib) (seriousness criterion medically significant) and HEART RATE INCREASED (fast heartbeat). At the time of the report, ATRIAL FIBRILLATION (afib) and HEART RATE INCREASED (fast heartbeat) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Apr-2021, Heart rate: abnormal (abnormal) Abnormal.     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 were provided. Treatment included furosemide, eliquist and flecinade.  Company comment: Very limited information regarding these events has been provided at this time. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: No specific follow-up information recorded.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Administered PNEUMOVAX in right delt, then FLUZONE HD in left delt. After 2nd shot, patient immediately turned bright red and throat swelled up 3x normal size. In response, I immediately administered EPI-PEN 0.3 mg IM in right thigh. Within 1-2 mins, patient returned to normal color and throat swelled down. Patient stated she felt normal again and could breathe. She left with EMT and went to ER to be safe. She was discharged from ER 2 hours later and has no problems since EPI-PEN.
The patient started having shortness of breath  (has asthma) , severe headaches, more pain than usual (has fibromyalgia), chills and a low grade fever for about 10 days after the shot. These symptoms lasted for about 3 weeks after the shot
Patient was fine receiving vaccine. Was walking out of the vaccine area with her three sisters and Mom. She passed out and collapsed within a few steps of the consultation area. She woke up immediately and was talkative and aware of person, place, and time. We brought her back to vaccine area, laid her down with feet up, put cold wet paper towel on her forehead, gave her cold water to drink and a popsicle to eat slowly. She began feeling better and her color returned to her face within 10-15 minutes.
Patient fainted after COVID-19 vaccination,.  Clinic personal assessed and EMS on site.  Patient refused transfer to medical facility.
Left deltoid became red and swollen about 12 hours after IM immunization with KINRIX. Not painful. No fever. Seen back in same office 3/8/17 and diagnosed with arthus phenomenon. Patient was already improving so no intervention done.
pt recv vax & devel rigors, fever, chills, nausea & malaise;pt was recovered as of the date of this report;this is one of three pt from this site to report these adverse rxn;
numbness in lower face, lips, tongue and redness in this area. Rapid heart beat and headache.
Shots given around 11:00 am, 12:00 pm one hour later patient felt, pokes and itchiness all over body was given prescription for Benadryl, patient came at 3:30 to let us know.
Pain in middle of chest (sternum area), shortness of breath, and coughing. These are exactly same symptoms, though not as severe, when I sick with COVID-19 in December 2020 (confirmed positive via 2 tests). These symptoms manifested on 5/24, two days after severe headache, body aches (joint pain), and chills/sweats following vaccination on 5/22.  As of writing this report (5/25), I still have a tightness in my chest, a slight cough, and a headache.
balance problems.. that got worse over 2-3 months then leveled off but have now increased after having the coroavirus in July 2022
4 VACCINES GIVEN AT 12:10:  HPV, MCV IN L. DELTOID.  HEP A, TDAP R. DELTOID.  PHONE CALL FROM MOM @ 1500 STATES WENT TO PMD ENROUTE TO ER.  PT. C/O LIGHTHEADED AND WHEEZING.
2 days after receiving his 6th grade shots he developed huge hives on his left arm. at least 11.   did not have breathing problems.   plan was to give benadryl and call if worsens or no improvement - would assume this resulted in improvement as there was no return call and no visit to an urgent care clinic
arm is sore; bump on her finger that feels like it's getting worse; nightmares; This spontaneous case was reported by a consumer and describes the occurrence of NIGHTMARE (nightmares), MYALGIA (arm is sore) and PERIPHERAL SWELLING (bump on her finger that feels like it's getting worse) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included SUMATRIPTAN SUCCINATE (IMITREX DF) for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced NIGHTMARE (nightmares). On 24-Mar-2021, the patient experienced MYALGIA (arm is sore) and PERIPHERAL SWELLING (bump on her finger that feels like it's getting worse). At the time of the report, NIGHTMARE (nightmares), MYALGIA (arm is sore) and PERIPHERAL SWELLING (bump on her finger that feels like it's getting worse) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported .
if he even touches his head, it hurts; feeling very achy/feels body was crushed; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (if he even touches his head, it hurts) and MYALGIA (feeling very achy/feels body was crushed) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 021C21A) for COVID-19 vaccination.     The patient's past medical history included Back surgery.   On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jun-2021, the patient experienced HEADACHE (if he even touches his head, it hurts) and MYALGIA (feeling very achy/feels body was crushed). At the time of the report, HEADACHE (if he even touches his head, it hurts) and MYALGIA (feeling very achy/feels body was crushed) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.  Treatment information included Eurafina.
Erythema at injection site with enlarging lump and development of axillary edema and erythema, with no appearance of infection, worsening over a period of 3 weeks. Initial symptom onset with 1 hour of injection.
Less than 24 hours after injection, pt noted more that normal soreness to left upper arm. Increased pain/ aching on movement. Left arm felt warm. Arm was ore for about 3 days, then felt much improved.
Approximately 24 hours later developed localized erythema and edema at injection site measuring 7cm x 4cm.
First lethargic for 1.5 hrs then screaming from 11AM - 3PM, t101; Seen by MD about 330PM on 13NOV91;
Information has been received from an RN concerning a 35 year old Caucasian female who was vaccinated with the 2nd dose of Hep-B. Subsequently, the pt experienced redness and rash at the injection site. She was vaccinated with 3rd dose of Hep-B on 4/4/00. On approx. 4/5/00, the pt experienced erythema multiforme and a macula rash on the upper part of both thighs. She also experienced raised erythema around the injection site (about 8cm in diameter). The rash on the thighs only persisted for 24 hours. The injection site rash persisted for approx. 3 days. Medical attention was sought. She was treated with po Benadryl. The pt recovered on approx. 4/7/00. No further information is available.