chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had a seizure around 6:55 p.m. 9/9/11. We rushed him to the ER, they did a CT scan of his brain and found blood.  He had massively increased cranial pressure, the fontanel was completely full, there was no detection it was even there. They transferred him to another ER where another CT was done with contrast. They said he had an AVM and possibly an aneurism.  They did an angiogram, on 9/11/11 around 10 a.m., to find out if he had an aneurism or not.  When the procedure was concluded, Dr., said he found no aneurism or AVM. He ruled it non-accidental trauma.  They then proceeded to do a full abuse work up which included a full skeletal survey and retina exam.  The skeletal survey, performed on 9/11/11 around 12 p.m., was normal. Although, the retinal exam, executed on 9/12/11 around 1 p.m., showed retinal hemorrhages. They then diagnosed the "non-accidental trauma" Shaken Baby Syndrome.
Patient tested positive for Covid-19 on 04/16/2021.  Presented to the ED at the urgency of her cardiologist for a right foot Infection. She notes a  chronic non-healing wound on her right foot and today on a routine follow up.   He recommended going to the local  ER for evaluation of cellulitis. She denied any fevers, chills, chest pain, headache, visual disturbances or near syncope. When she arrived to the ED vital signs were stable and plain films obtained of the Imaging was negative tor osteomyelitis. She Is being admitted under the hospitalist service for further management.  Patient discharged to rehab facility and died on 05/20/2021.
Itchy vesicular rash emptic 3/4/07 on abdomen - spread increase there one dm. 5-10 wet. 5 more red, raised one Left eyebrow 3-4 Scalp 2-3 Left leg.
This spontaneous report as received from a pharmacist refers to multiple unspecified patients of unknown age and gender. Patients pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On unknown dates these unspecified patients were vaccinated with improperly stored PROQUAD (strength, dosing details, anatomical location, lot# and expiration date were unknown). No patients reported adverse effects. No product quality complaint was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Reports both arms "achy, throbbing" "unable to lift anything".  Denies any redness, swelling.
not feeling well; cannot eat, and has no appetite; Fatigue; Sick to her stomach; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FATIGUE (Fatigue), ABDOMINAL DISCOMFORT (Sick to her stomach), MALAISE (not feeling well) and DECREASED APPETITE (cannot eat, and has no appetite) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced FATIGUE (Fatigue) and ABDOMINAL DISCOMFORT (Sick to her stomach). On an unknown date, the patient experienced MALAISE (not feeling well) and DECREASED APPETITE (cannot eat, and has no appetite). At the time of the report, FATIGUE (Fatigue), ABDOMINAL DISCOMFORT (Sick to her stomach), MALAISE (not feeling well) and DECREASED APPETITE (cannot eat, and has no appetite) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
at first declined having any side effects then said a headache that resolved on its own; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (at first declined having any side effects then said a headache that resolved on its own) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (at first declined having any side effects then said a headache that resolved on its own). At the time of the report, HEADACHE (at first declined having any side effects then said a headache that resolved on its own) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-328744 (Patient Link).
Severe skin rash; thought to be something similar to erythema multiforme major; lasted 2 months, extreme tighing; started on arms and moved to legs; red circles looked like rings; red and raised.
She has been diagnosed with "frozen shoulder" which can last up to 18 months per her Physician
Flublok vaccine administered to 16 year old male on 9/18/20.  No reactions noted.
Redness around inside of left arm starting just below vaccine administration site and moving inside worsening over previous 24 h.
7/30/2016 - Spoke to patient on the phone - patient stated there was a small bruise at injection site - right deltoid and upper arm (above shoulder) was tender, red, and swollen slightly - warm to the touch with noticeable pain. 7/31/2016 - Per patient on the phone, right deltoid pain has gone down however upper arm (above elbow) remains swollen, red, warm to touch, and tender to touch with pain. There is a bruise about 1/2" at injection site. Advised the patient to use ice packs throughout the day to reduce swelling and acetaminophen 500mg QID prn if necessary for pain - per patient, able to tolerate pain for now. Pharmacy will contact her throughout the next 2-3 days to inquire about status if warrant a visit to MD if symptoms worsen and do not improve.
GAVE WRONG AMOUNT FOR 2ND BOOSTER; PATIENT RECEIVED 0.5ML
osteoarthritis in her back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 12Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "osteoarthritis" (ongoing), notes: she has osteoarthritis in her back and they want her to start a new medication called Prolia. The patient's concomitant medications were not reported. The following information was reported: SPINAL OSTEOARTHRITIS (non-serious), outcome "unknown", described as "osteoarthritis in her back". Therapeutic measures were taken as a result of spinal osteoarthritis.  Additional information: patient got her 1st dose on 12Mar2021 and she's supposed to get her 2nd on 04Apr2021, however she has osteoarthritis in her back and they want her to start a new medication called Prolia. She stated she was on a different medication, but it didn't work for her. She's supposed to get a Prolia injection on 23Mar2021 and wants to know if it would be alright or not. Clarified if she had osteoarthritis prior to the 1st dose, and she said she did. Clarified when the doctor discussed putting her on Prolia, she said she talked to them after the 1st dose and they decided to put her on it.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient is a 73 y.o. female patient of MD with history of diabetes mellitus, stroke, hyperlipidemia, hypertension, closed rib fracture presented to Hospital with weakness, was found to be COVID-positive with AKI and possible UTI.   Covid-19 Virus Infection Date of onset of symptoms: 11/30/22 Symptoms present on admission: Cough, shortness of breath, sore throat, runny nose, weakness, anorexia   Date of covid positive test: 12/2/22 Vaccination status: vaccinated Imaging: Chest x-ray negative  Oxygen requirements on admission: None Current oxygen requirements status post paxlovid Consultants following: ID Anticipated special isolation end date: 12/12/22   AKI Likely secondary to dehydration Baseline Creatinine normal Presented with Creatinine 1.79 Creatinine much improved back to 1.1 with IV fluid UTI UA positive for leukocytes and bacteria  Status post IV fluid hydration IV cefazolin discontinued per ID Culture negative    HTN Continue home Amlodipine, hydrochlorothiazide, hold Lisinopril due to AKI   Diabetes Takes Metformin at home, on hold due to AKI SSI as needed    Chronic Fatigue History of stroke, left side effected  PT/OT eval and treat  Care management consult    Hyperlipidemia  Continue home Atorvastatin    Hx Stroke Continue home ASA 325 daily    Generalized weakness PT OT
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 40-year-old female patient who received Influenza vaccine. On an unknown date, the patient received Influenza vaccine. On an unknown date, an unknown time after receiving Influenza vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to Influenza vaccine. Additional details were provided as follows: This case was not previously reported to anyone. The patient was a pharmacy technician. The patient experienced injection site pain after receiving the flu shot. For tolerance to next vaccination, refer case US2015148969.
08mar90 pt vax 3rd hepta B.  11mar90 pt devel. temp of 102 F.,h/a, cough, sweating, arthralgia, and myalgia.  pt treated w/ tylenol and erythromycin.  lab eval. on 12mar90 revealed WBC 13,000 and on 13mar90 WBC was 10,000. exp. due to virus
flu 3 times in a row; Initial information received on 27-Nov-2020 regarding an unsolicited valid non-serious case from a patient.  This case involves a patient of an unknown demographics who had flu 3 times in a row (influenza), while being treated with vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose and frequency via unknown route and unknown site for prophylactic vaccination.  On an unknown date (unknown latency), after starting the suspect vaccine therapy, the patient had flu 3 times in a row (influenza).  No laboratory data was not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.
Initially, there was soreness, swelling, and redness (all around upper arm - a bit below deltoid) around injection site over the course of a few days. The area was warm to the touch compared to the rest of the arm. All symptoms went away after 5 days. Exactly 7 days later, a little bit of the soreness came back and there was a redness marking the size of a 50 cent coin. The next day, the soreness grew and the redness spread and the area became warm to the touch again. I talked to a doctor over video chat to talk about what I should do - I was advised to use an ice compress, which I did a few times on and off. The next day (today), redness spread, but soreness and feeling warm to the touch stayed the same. I went to urgent care and was given 7-day antibiotics and told to use Claritin/Zyrtec to lower my histamines. If anything progresses, I should let the provider know.
As I was entering the data for the covid tracker on 4/11/21, I realized that the number of vaccines administered  on 4/10 did not match to the number on the CIR administered report. Since we are closed on Sundays, I checked the immunization screening forms to the ones we did on 4/10. I realized that this particular patient already received both doses of Moderna in March and the JJ we administered did not get registered in the registry. I tried calling the patient twice with no success. And even left messages. I reached out to CIR and they consulted with a physician who said we did nothing wrong and to make a VAERS report.
one of two pts who exp a local reaction (reporter felt reaction was cellulitis or allergic reaction); w/in 24 hrs p/DTP/OPV; pt also had swollen lymph nodes & a fever; no tx initiated;
chills; body ache; headache; fatigue; upper chest discomfort with deep breath; This is a spontaneous report from a contactable other health professional (patient herself). A 42-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3246), via an unspecified route of administration on 02Jan2021 11:00 in left arm at single dose for covid-19 immunization. The patient medical history was not reported. Allergies to medications, food, or other products was no. Concomitant medication included escitalopram oxalate (LEXAPRO, 10 mg) and vitamins nos (MULTIVITAMIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The most recent COVID-19 vaccine was administered in pharmacy or drug store. The patient experienced symptoms chills, body ache, mild headache, fatigue, and upper chest discomfort with deep breath on 06Jan2021. Patient never had a fever. Symptoms were resolved by the next day (07Jan2021).  No treatment was received for the events. All events were reported as non-serious.    No follow-up attempts are possible. No further information is expected.
Information has been received from a lawyer regarding a case in litigation concerning an approximately 72 year old female. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In January 2016, the patient was administered the ZOSTAVAX by a health care provider (lot number, dosage and route of administration not provided). In December 2016, the patient was treated by a by a health care provider for the following injury resulting from her use of ZOSTAVAX: shingles. The patient claims damages as a result of: injury to herself, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Nervousness; High Anxiety; Headache; Muscle pain; High Blood Pressure; Tremors; This is a spontaneous report from a contactable consumer (patient). A 56-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 05Aug2021 at 19:45 (at the age of 56-years) as dose 2, single in the left arm for covid-19 immunisation. The patient medical history included HIV, blood pressure, anxiety, depression from an unknown date and unknown if ongoing. The patient had no known allergies. The patient concomitant medications included piroxicam (PAXIL), cobicistat, darunavir ethanolate (PREZCOBIX), raltegravir potassium (ISSENTRESS), bupropione, amlodipine from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on Jul2021 at 19:30 (at the age of 56-years) as dose 1, single in the left arm for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 15Aug2021 at 12:00, the patient experienced nervousness, high anxiety, headache, high blood pressure, muscle pain, tremors. Patient received treatment for events with Amlopidine 10mcg, Xanax Half a pill of 1mcg as needed. Patient visited to Doctor or other healthcare professional office/clinic. The events was assessed as non-serious. The outcome of events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (08Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Heart palpitations- began about 4 weeks after first dose of vaccine, have been intermittent since then, increasingly uncomfortable.  Headache Fatigue
body rash that is a bright red area on her feet, ankles, up her legs, arms, belly, and back; UTI; chills; nausea; dizziness; weakness; no appetite; fast heartbeat; fatigue; headache off and on; A spontaneous report was received from a consumer concerning a 81-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fatigue, headache off and on, uti, chills, nausea, dizziness, weakness, no appetite, fast heartbeat, body rash that is a bright red area on her feet, ankles, up her legs, arms, belly, and back.  The patient's medical history was not provided. Concomitant medications reported were Prilosec, Vitamin D for drug use for unknown indication.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 14 Feb 2021, the patient experienced the event(s) fatigue, headache off and on. On 18 Feb 2021, the patient experienced the event(s) uti, chills, nausea, dizziness, weakness, no appetite, fast heartbeat. On 21 Feb 2021, the patient experienced the event(s) body rash that is a bright red area on her feet, ankles, up her legs, arms, belly, and back.  Treatment details included Kenalog for fast heartbeat, Macrobid for the UTI she developed, and Tylenol off and on, which, seemed to help.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), fatigue, headache off and on, uti, chills, nausea, dizziness, weakness, no appetite, fast heartbeat, body rash that is a bright red area on her feet, ankles, up her legs, arms, belly, and back was unknown.
Moderna Cov-19 vaccine EUA. Two weeks after receiving first shot, woke up with red, hot, itchy patch on my left arm around the area of injection.  Raised small bumps.  Measures about 2 inches wide by 3.5 inches high.  It does not hurt or impede activity.
dizziness, loss of vision, thinking he was going to faint. cold compress and water given to patient, continued to feel off, so called 911 - blood sugar and blood pressure slightly elevated. patient declined to go to emergency room as recommended by ems, and says he feels okay to go home
unable to go to work/Bad reaction; patient had received second Shingrix dose onemonth late at 7 months past the first dose; This case was reported by a pharmacist via call center representative and described the occurrence of inability to work in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date ).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced inability to work and drug dose administration interval too long. On an unknown date, the outcome of the inability to work and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the inability to work to be related to Shingrix.  Additional details were received as follows: The patient received second Shingrix dose one month late at 7 months past the first dose, which led to lengthening of vaccination schedule.  The patient told her she was unable to go to work for one week after getting the vaccination. HCP calling regarding a female patient On an unknown date the patient received dose one of Shingrix and 7 months later received dose two. The HCP reported the patient experienced a bad reaction after receiving dose two.  The reporter did not consented to follow up.  The pharmacist was reporting a patient that had experienced this in the past.  The patient did not know all the details.
Clinical Summary Patient is a 75 y.o. male with a history of Migraines, Afib and Cerebral amyloid angiopathy with associated cognitive decline who presented to RMH 10/22/2022 with acute worsening of confusion, expressive aphasia and generalized weakness found to have nonacute CT head and CTA H/N and COVID positive   1. Acute on chronic metabolic encephalopathy: with chronic vascular/amyloid dementia - precipitated by likely COVID. At baseline Oriented x 2. MRI brain - limited study 10/22/22 showed no acute infarct.  EEG with no epileptiform activity. Improved.  2. COVID 19: diagnosed 10/22/22 with wife being recently positive. Asymptomatic except as above and on room air. Isolation through 11/2/22 per infection control. 3. Afib RVR: Known history, not on AC due to amyloid. Continued ASA. Previously on BB - but stopped as HR controlled and soft BP. Restarted BB 10/23.  HR controlled
Needle punctured arm, vacinator attempted to admintster and dose squirted outside. Less than 50% was administered if any at all
The patient received junior COVID Pfizer dose instead of adult dose.  Patient was called same day and notified of error. Patient returned to pharmacy 10/12/23 to get adult dose.  Patient reported no adverse reactions.
she had injection site reaction/same thing happened; Dizziness; Mild nausea/Nothing horrible but the nausea is annoying.; Tiredness; Muscle ache in her trunk area/Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (she had injection site reaction/same thing happened), DIZZINESS (Dizziness), NAUSEA (Mild nausea/Nothing horrible but the nausea is annoying.), FATIGUE (Tiredness) and MYALGIA (Muscle ache in her trunk area/Sore arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A, 031A21A and 002A21A) 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 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (she had injection site reaction/same thing happened), DIZZINESS (Dizziness), NAUSEA (Mild nausea/Nothing horrible but the nausea is annoying.), FATIGUE (Tiredness) and MYALGIA (Muscle ache in her trunk area/Sore arm). At the time of the report, VACCINATION SITE REACTION (she had injection site reaction/same thing happened), DIZZINESS (Dizziness), NAUSEA (Mild nausea/Nothing horrible but the nausea is annoying.), FATIGUE (Tiredness) and MYALGIA (Muscle ache in her trunk area/Sore arm) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: clean (normal) clean. On an unknown date, Urine analysis: clean (normal) clean.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided.   No treatment medication were provided   This case was linked to MOD-2021-333515, MOD-2021-333533 (Patient Link).