chrisvoncsefalvay/vaers-outcomes huggingface dataset:
46 y/o male who developed left shoulder pain approximately 2-3 days following receipt of FLUZONE (Sanofi-Pasteur) on 11/2/2010, which has persisted. Vaccine was administered in his left deltoid area in afternoon. He did not notice anything unusual about vaccine administration technique or site. Within 8 hours patient felt "bad". He reports a fever of 101-104, fever and sweats alternating with chills, red, watery and puffy eyes, body aches, and malaise which lasted about 24 hours. He denies rashes/urticaria, flushing, wheezing or dyspnea, angioedema, dysphagia or GI-related symptoms. He called the clinic where he received the vaccine the day after vaccine receipt to report his viral-type symptoms and he was told these symptoms are not uncommon. His vaccination site was red (< 2" diameter), but not warm to the touch. There was no significant swelling or bruising, but the site was tender to touch. His left shoulder pain began within a 2-3 days post-vaccine administration. Pain intensity initially ranged from 4-10/10 on pain scale of 0 (=no pain) to 10 (=worst pain ever experienced). Pain has persisted and significantly restricted ROM and interfered with sleep; it is difficult for patient to reach over his head or reach down or rotate his arm; when he does, he experiences a sharp, shooting pain from his shoulder to his wrist. He denies any L) UE tingling, numbness, or weakness. Currently pain is only associated with movement and intensity is rated as 8-10/10. About 6-weeks after onset, patient sought evaluation and was told that pain would resolve on its own. It has persisted so he sought evaluation with his PCM last week. He was prescribed Naproxen 500 mg twice daily and multiple tests were run, as well as imaging studies. (Results pending). Patient reported feeling well day of and prior to vaccinations. He denies a history of recent trauma or injury to his L)UE. He denies allergic reactions to drugs, foods, latex, or insect stings. No prior vaccine reactions. His PMH is negative except for high cholesterol for which he takes Simvastatin.
Fever and aches for immediate 2 days after injection. Singles developed on forehead within 1-2 days after injection.
Pt with onset of baseball size redness, warm to touch, tender. Benadryl, Tylenol/Motrin, cool compresses ordered.
facial paralysis/facial drooping/facial palsy/eyes started drooping and then mouth started drooping; strange feelings in face; This is a spontaneous report received from a Pfizer sponsored program.This contactable consumer patient himself and a contactable physician psychologist, (parent of patient reported) that a 33-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration, administered in left arm on 21Mar2021 16:15 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination.  On 21Mar2021 at 07:30 PM, after receiving his first dose, he began noticing facial drooping, which began to intensify, on the right side. He was advised by a medical professional to immediately call an ambulance and he was then taken to an emergency room where received a CT scan and full bloodwork on Mar2021. Luckily, the facial palsy began to subside and he was able to return home after the test results came back and a stroke was ruled out - it was stated that this was some kind of immuno-reaction to the vaccine. He still felt as though his face was still not 100% back to normal and still felt a bit droopy (noticeable in the mirror) yet it does feel better than on 21Mar2021 evening. Patient had a nasal swab on 22Mar2021 with negative result. One of the reporters is a psychologist and reported that her son received Pfizer-BioNTech COVID-19 Vaccine. Psychologist asking about risk of Bell's palsy, incidence, and outcomes and if these patients received their second dose of the Pfizer-BioNTech COVID-19 Vaccine. She read about 7 cases of Bell's palsy in a Dec2020 article in the [Redacted], 4 of them on the Pfizer vaccine. The reporter further clarified and described that at 6pm (2 hours after dose), patient reported he felt fine and was happy he got the vaccine; but then sometime after that, he reported "strange feelings in face" and then eyes started drooping and then mouth started drooping, all on right side of face. They called the university clinic and was instructed to go to ER. Brain scans and blood work were done; they ruled out stroke and said it was a possible reaction to the vaccine. He was discharged at midnight and by then, paralysis was 80-85% resolved. He is an otherwise very healthy young man. The psychologist wanted to know the efficacy after just one dose and stated that a friend suggested to perhaps not get second dose and consider getting a dose of the non mRNA vaccine like Johnson and Johnson.  The outcome of the event was recovering.   Information on Lot/Batch number has been requested.
Allergic reaction: severe itching all over body, scalp, and tongue, difficulty breathing, skin inflammation, couldn't sleep due to itching. Symptoms began around 8pm on 04/11/2017 and lasted until around 04/20/2017. The following morning (04/12/2017) at around 9am patient went back to the student health clinic listed in this report to complain about their symptoms. Student was advised to purchase the strongest over the counter antihistamine they could find, a beta blocker, 1% hydrocortisone anti-itch creme, scalpicin, albuterol inhaler, and TYLENOL, and to use these products concurrently to reduce effects of symptoms. Only by using all of these products together for over a week was patient able to ride out the symptoms, but the symptoms still affected their sleep, comfort, and ability to concentrate during the day. The reduced ability to breathe was especially frightening.
30min post vax experienced urticaria on side of her face; Subsequently developed a h/a, low grade fever & myalgias; sx resolved x/myalgias which persisted for one month;
1. Convulsions, chills. So out of control that patient passed in and out of consciousness. Upon waking up, gasped for air as if unable to breathe while unconscious. Unknown amount of time between unconscious and conscious states. Shivering seemed to be an issue of temperature regulation as she reported feeling cold while her temperature remained above 98.5 degrees. (Continued for 7 hours). She could feel the heat of her body within her blankets but in her bones, she was freezing and unable to stop convulsing. Shaking so badly that she could not hold water to her face in order to drink. Could not effectively chew and swallow crackers without the danger of cooking.  2. Shortness of breath. Felt like a great weight on chest. Unable to complete sentences without multiple in/out breaths.  3. Patient would forget, mid sentence,  what they were talking about or where they were going with current conversation.  4. Resting HR at 92bpm 5. Headache. Felt as though brain matter was trying to push through the skull.  6. Lymph node under the arm pit extremely sore as if stabbed. Injection site felt similar. 7. Joints, muscles Felt stiffened and unable to move freely. 8. Light sensitivity to the eyes. 9. Throat tensed tightly, leaving the patient barely able to breathe properly.  10. Temperature regulation continued to be abnormal after convulsions stopped. Too hot or too cold, no comfortable in between. 11. Patient would take very deep breaths, but it did not seem to help calm convulsions and it didn't feel like enough air was taken in. 12. Movement caused light coughing. 13. Emotions were/are difficult to regulate. Crying while convulsing. After convulsions stopped, patient would attempt to talk and would become emotional at inappropriate times.  14. Thoughts of suicide should symptoms persist. 15. By day 4, patient remains short of breath when above resting HR.
Pain in the chest; Water in lungs; Pain in the neck and left side of sternum; Soreness in arm; Fatigue; A spontaneous report was received from a consumer, concerning a 67 year old male patient, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273), and experienced pain in the chest (chest pain), water in lungs (pleural effusion), pain in the neck that went down the left side of sternum (neck pain radiation), soreness in arm (pan in extremity) and fatigue.  The patient's medical history was not provided. Concomitant medications reported included warfarin sodium, ezetimibe, fiber, and vitamin D NOS.  On 06 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Lot number: 011L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 03 Feb 2021, prior to the onset of events, the patient received the second of two planned doses of mRNA-1273 (Lot number: 028L20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.   On 03 Feb 2021, an unspecified duration after receiving the vaccine, the patient experienced soreness in the arm and fatigue.   On 08 Feb 2021, the patient experienced pain in the neck on the left side which radiated to the left side of sternum.   On 12 Feb 2021, in the morning, the patient experienced a huge pain in the chest and called 911 for an ambulance. The cardiologist and pulmonologist stated that everything was fine except that there was some water in the lungs. The patient still has pleural effusion. On the same day, the patient underwent electrocardiogram (EKG) and heart CT without significant findings and no abnormalities. The patient was recommended for a computerised tomography (CT) arteriogram.   Treatment medications included acetaminophen, codeine, fentanyl, and concomitant medications.  Action taken with second dose of mRNA-1273 in response to the events was not applicable.  The outcome of the events, pain in the chest, water in lungs, pain in the neck that went to the left side of sternum, soreness in arm, and fatigue were not reported.; Reporter'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.
dizziness; Headache; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Headache) and DIZZINESS (dizziness) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced DIZZINESS (dizziness). At the time of the report, HEADACHE (Headache) had not resolved and DIZZINESS (dizziness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
This spontaneous report was received from a company representative and registered nurse and refers to a 20-year-old female patient. The patient's medical history and concomitant therapies were not reported. The patient did not have any pre-existing physician-diagnosed allergies, birth defects and medical conditions. The patient's vaccine history included vaccination with a first dose of MENACTRA intramuscular in the right deltoid, lot# reported as U59116AA on 14-JUN-2018 and a first dose of TDAP intramuscular in the right deltoid, lot# reported as 9GM3R on the same day. The patient's measles, mumps, and rubella (wistar ra 27-3) virus titer status was not known. On 12-JUL-2018, the patient received three vaccines at a private doctor's office in the following order: firstly she was vaccinated with a first dose of GARDASIL 9 injection, intramuscular in the left deltoid, lot# N035955, expiration date: 09-OCT-2020 (exact dose was not reported) for human papillomavirus infection (HPV) vaccination, then with a first dose of M-M-R II subcutaneous in the right arm, lot# N027781, expiration date: 08-AUG-2019 (albumin status and exact dose were not specified) (it was reported she needed to receive it for a job) and with a first dose of ENGERIX-B intramuscular in the left deltoid, lot# reported as GR55T (exact dose and expiration date were not reported). On the same day, after receiving GARDASIL 9, the patient experienced a reaction which was described as vasovagal syncope. The patient became nauseated and had mild myoclonic jerks. Her blood pressure (BP) was reported as 110/70 (units not provided). The patient was also reported to be disoriented and was observed in the office for 20 minutes then went home. Shortly after, she experienced dizziness, shortness of breath (SOB) and anxiety and came back to the clinic later that day at an unspecified time. She was reported to be still disoriented. Her BP was 90/58 (units not provided) and her heart rate (HR) was 77 (units not provided). She was again observed for an unspecified period of time and left that same day and was believed to be recovered on an unknown date in July 2018. It was believed that the patient had the reaction after receiving the GARDASIL 9 and then went on to receive M-M-R II and ENGERIX-B after the reaction but that could not be confirmed. There was no illness at the time of vaccination. There was no treatment given for vasovagal syncope and disorientation. The patient received prescription for ZOFRAN 4 mg as a treatment for nausea. There was no hospitalization. There was no digital data logger involved and no product quality complaint involved. The outcome of the events was reported as recovered on an unspecified date in July 2018. The relatedness between GARDASIL 9, M-M-R II, ENGERIX-B and the events was not provided.
Patient presented to the ER complaining of difficulty breathing. Patient was ill approximately 1 week ago and received Abx and steroids. She improved but then few days ago she started to have SOB again. Was given steroids but they did not help. She has not been on inhaled steroid but is on spiriva. At home patient utilize multiple albuterol treatments without any effect.  Patient was started on IV steroids and subsequently started on p.o. DEXA.  also received doxy.  Patient received remdesivir for total 2 days. She did not qualify for home oxygen. Patient remained hemodynamically stable throughout hospital stay and was discharged in stable condition.
This spontaneous report as received from an immunization program refers an patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of improperly stored GARDASIL (route, site, dose, strength not reported, lot # H021861, exp. date: 09-OCT-2015). This is one of severeal reports received from the same source (linked MARRS#: 1310USA014881, 1310USA014883, 1310USA014888, 1310USA014891, 1311USA000056, 1311USA000071, 1310USA015417, 1310USA014897, 1311USA000012, 1310USA014858, 1310USA014850, 1310USA014870, 1311USA000289, 1311USA000282, 1310USA014874, 1310USA014866, 1310USA014861, 1310USA015422, 1310USA015165, 1311USA000069, 1310USA015424, 1311USA000058, 1311USA000042, 1311USA000013, 1310USA015170, 1311USA000014, 1310USA015153, 1310USA015090, 1311USA000067, 1311USA000064,  1311USA000020, 1311USA000021, 1311USA000040, 1310USA015096, 1311USA000022, 1310USA015101, 1311USA000053, 1310USA014853, 1311USA000075, 1310USA014895, 1311USA000059, 1310USA015119, 1310USA015113, 1311USA004931, 1311USA000065, 1310USA014853, 1311USA000739). Additional information is not expected.
Myalgia, UrticariaPruritus, Warm and erythema at the injection site;  approximately 2 inches in diameter Narrative:
Ulcerative colitis; bowel symptoms; This serious case was reported by a consumer and described the occurrence of ulcerative colitis in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11-JUL-2023, the patient received the 2nd dose of Shingrix. On 12-JUL-2023, 1 days after receiving Shingrix, the patient experienced ulcerative colitis (Verbatim: Ulcerative colitis) (serious criteria GSK medically significant). In JUL-2023, the patient experienced bowel dysfunction (Verbatim: bowel symptoms). The patient was treated with tofacitinib citrate (Xeljanz). The outcome of the ulcerative colitis and bowel dysfunction were not resolved.   It was unknown if the reporter considered the ulcerative colitis and bowel dysfunction to be related to Shingrix.     It was unknown if the company considered the ulcerative colitis and bowel dysfunction to be related to Shingrix.   Additional Information: GSK receipt date: 26-Jul-2023 Ulcerative colitis was in remission.  The patient took Xeljanz to treat, 2 days after dose 2 the patient started to have bowel symptoms that were still ongoing. The reporter was requested for consent to follow up.
Syncopal event, loss of consciousness s/p vaccination, systemic erythema, flushing, diaphoresis, fever, chills, vomiting
Pt contracted shingles disease; reported pain and scabs on Rt side of torso. Saw Primary doctor and receieved. RXs for Valacyclovir, and Gabapentin. Six weeks later she is still experiencing pain (though less than at first)and is on Acyclovir daily.
presents to the ED due to and oriented and hypoxia. *Together by EMS who states that patient had elevated heart rate, hypoxic requiring 4 L nasal cannula, not on oxygen at home
On Friday night, 3/19/21, patient spiked a fever, had shortness of breath, and had blood coming out of his nose and mouth per patient's daughter-in law.  9-1-1 was called, paramedics arrived at the home at 5AM on Saturday, 3/20/21 per patient's daughter.  Patient died.
The pt developed hives which began 48 hours after vaccination. Pt seen 72 hours after injection and improved. A follow up report received 5/17/2002 adds: No local site reaction.
Excruciating abdominal pain, vomiting, chills, night sweats, fainting that caused Concussion , nausea
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. No concurrent conditions, historical conditions or concomitant medications were provided. In approximately 1991 (reported as 20 or 25 years ago) the patient was vaccinated with unknown hepatitis B vaccine (manufacturer unknown) (dose, route of administration, lot # and expiration date were not provided). It was reported that on an unknown date (reported as recently), an unknown blood test did not show that the patient had the immunity to Hepatitis B. The outcome of the event and causality were not provided. Additional information is not expected as the reporter did not wish further contact.
Cellulitis at injection site with growing erythema 1 day post vaccination. Treated with a 10 day course of Clarithromycin 250 mg BID X10 days.
over 6 weeks beyond the recommended dosing interval; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (over 6 weeks beyond the recommended dosing interval) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (over 6 weeks beyond the recommended dosing interval). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (over 6 weeks beyond the recommended dosing interval) 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.   No concomitant medications and treatment information were reported.
woke up screaming from nap, mom picked pt up then lay pt down to change him & noted rhythmic jerking of arms & pale & limp for few minutes;no fever @ that time;about 20min later seemed fine;
Patient administered moderna covid vaccine while temperature excursion was ongoing; Patient administered moderna covid vaccine while temperature excursion was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion was ongoing) in a 23-year-old female patient 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion was ongoing). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion was ongoing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.   The treatment information was unknown.
MOC called RN at 1900 on 10/29/13 at home to report "hard, red, shiny swelling" to (R) deltoid that began 10/29/13 during day. Size reported as approx 1/2" height "baseball" diam. MOC instructed to apply ice pack 20 min, off 20 mins, alternating et admin acetaminophen or ibuprofen PRN. Improving at call 10/30/13 at 0745. Swelling now size of "small lemon" per MOC.
Case number PHEH2014US025328, is an initial spontaneous report from a medical assistant received on 16 Dec 2014. This report refers to a 70-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient had tolerated vaccines (no further details provided) well in the past. On 17 Oct 2014, the patient was vaccinated with 0.5 ml of FLUVIRIN (batch number: 145701, expiry dates: Mar 2015) intramuscularly into left deltoid muscle that was stored at minus 0.6 degrees Celsius for 2 hours and 50 minutes. No adverse reaction was reported following this medication error.
Began with low fevers and extremely upset stomach and severe nausea that lasted for 3 days.  Then turned to extreme fatigue and heart racing, and now my thyroid is crashing after being stable for past 15 years.
I am not what kind of flu vaccine it is, but it is documented in the Employee Health Record. Person is the Infection Control and Employee Health Nurse. Shot was given very high in the arm and hurt bad on when given. About 3 days later, I woke up from sleep in severe pain left arm and could not lift my arm without extreme pain. It is hard for me to even raise my arm now as the pain, numbness and dull ache is constant. I am afraid I have nerve damage. It is 24/7 pain. My shoulder is tighter and I cannot even take my shirt off without screaming.
WEEK 1: fever, chills, headache, weakness WEEK 2: fever, chills, migraines, weakness, GI symptoms WEEK 3: periodic chills, periodic headaches, weakness, periodic exhaustion, GI symptoms, elevated pancreatic enzymes  WEEK 4: weakness, GI symptoms, shortness of breath, exhaustion, heart block
Headache & Myalgia Narrative: day 1-headache/ fatigue and day 2- headache fatigue/ chills/ bodyache