chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chills; headache; very tired and worn out; This case was reported by a consumer via interactive digital media and described the occurrence of chills in a 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 chills, headache and tiredness. On an unknown date, the outcome of the chills, headache and tiredness were unknown.   It was unknown if the reporter considered the chills, headache and tiredness to be related to Shingrix.     Additional Information: GSK receipt date: 03-Apr-2022 Reporter's comment: The case was received from consumer via interactive digital media. The patient asked that how long after getting a dose of Shingrix could felt chills, headaches and very tired and worn out. Additional Supportive Information: The follow-up could not be possible as no contact details were available.
Swollen (R) deltoid with local erythema within 24 hours without progression, and fever.
Had booster on Monday afternoon.   Tuesday felt extreme fatigue and head ache.  Tuesday night went to bed and woke up during night with extreme nausea.  Made my way to the bathroom.   Fainted.  Hit head on wall which caused concussion and head laceration.   Husband found me unresponsive on the bathroom floor.   Due to extreme nausea, went back to bed.  I was not aware that I had a head injury until the morning when I found the bed pillow covered in blood.  Went to ER in the morning.  Had CT scan and ultrasound.  Required stitches/staples to scalp.
Client presented in clinic today to receive DTaP.  Mother states child received vaccines on 9/3/08.  Reports right leg red, sore and swollen.  Upon observation, child has reddened area right upper thigh approximately 4 1/4 in x 3 1/2 in.  Firm to touch upon palpation.  Spon cap refill to extremity.  Bears weight.  Unknown fever as mother had given 4 doses Tylenol yesterday and 1 dose this morning.  Instructed to contact MD if not improving or gets worse.
PT GOT SWELLING OF DELTOID AREA WHERE VACCINE WAS GIVEN. THE AREA IS RED, TENDER, HOT.  TREATED WITH BENADRYL.
Initial report received on 11 May 2007 from a health care professional. A 12-year-male patient had received a first dose, left deltoid, intramuscular injection of Menactra, lot number U1908AA, on 09 May 2007. On the evening of the same day, the patient developed lethargy and vomiting. He was examined "in the office" the following day and was complaining of vomiting, temperature of 99.7 degrees Fahrenheit, and a pink papular rash on his face. At the time of this report, recovery status was unknown.
This spontaneous report was received from a 61 year old female consumer reporting on herself with high blood pressure. The patient's medical history included bad reaction with DIAZIDE 30 years ago. On 28-DEC-2015, the patient was vaccinated with PNEUMOVAX 23, one shot subcutaneous in shoulder (lot #, expiration date and dose were not reported). Concomitant therapies included ALDACTAZIDE. On 03-JAN-2016, 7 days after onset of therapy the patient experienced pain on her left shoulder near the injection site, the pain then spread down to her rib cage. It was a throbbing pain that caused difficulty to walk and breathe. Additionally, she experienced shortness of breath. There were no laboratory diagnostics studies performed. No product quality complaint (PQC) was involved. The patient did not seek medical attention and no treatment had been received. At the time of report, the outcome of the events was not recovered. The relatedness between the adverse events and vaccination with PNEUMOVAX 23 was not reported. Additional information has been requested.
Swelling underneath the eye on the same side the shot was administered (right side); Aching on the right side leg; Redness by the injection area; General tiredness and fatigue; Swelling by the injection area; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Swelling underneath the eye on the same side the shot was administered (right side)), PAIN IN EXTREMITY (Aching on the right side leg), INJECTION SITE ERYTHEMA (Redness by the injection area), FATIGUE (General tiredness and fatigue) and VACCINATION SITE SWELLING (Swelling by the injection area) in a 38-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 29-Sep-2023, the patient experienced EYE SWELLING (Swelling underneath the eye on the same side the shot was administered (right side)), PAIN IN EXTREMITY (Aching on the right side leg), INJECTION SITE ERYTHEMA (Redness by the injection area), FATIGUE (General tiredness and fatigue) and VACCINATION SITE SWELLING (Swelling by the injection area). At the time of the report, EYE SWELLING (Swelling underneath the eye on the same side the shot was administered (right side)), PAIN IN EXTREMITY (Aching on the right side leg), INJECTION SITE ERYTHEMA (Redness by the injection area), FATIGUE (General tiredness and fatigue) and VACCINATION SITE SWELLING (Swelling by the injection area) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not reported.
Thyroid and adam's apple sore to the touch. Thyroid inflamed. There was also a short period of heart palpitations. After reading current case studies and consult with a medical professional, diagnosis was thyroiditis. Started 5 days after vaccine and peaked in 3 days. It resolved on the 4th day.
Pt was nervous about vaccine and reported that she sometimes feels faint when getting any shots. Pt laid down for vaccine. After nurse gave vaccine, pt c/o burning at injection site and started to panic. Pt was assisted by 2 staff to chair and stated she felt bad. Pt's eyes rolled back, lost all color in face and appeared to stop breathing. Pt eased to floor by 2 staff and NP checked for pulse. No pulse found and code called. NP gave chest compressions x 5 and coworker gave sternal rub. Pt responded, started breathing, became alert to her name, DOB and location. Vitals: BP 118/78, HR 90, RR 18 and NSR. Given 02 and EKG. EMS arrived and transported pt to ED for evaluation. Ed assessed pt and monitored with no new findings.  Pt discharged to home.
I woke up in the middle of the night and felt like I was having trouble breathing. My chest hurts and every breath is painful. Can?t sleep due to the pain. Only happened today so going to get covid test then if problem persists past tomorrow I?ll go the doctors
11/20/21 - Woke up normally but had episode witnessed by grandma of decreased LOC, found blue in the face. Maybe lasted 3-4 minutes. Did not seem to respond to pounding on back, though she did start breathing again. Woke up in ambulance with interventions, sternal rub. No convulsions or stiffening. Mom described roving eye movements when she was being stimulated. Now more irritable, sleepy but still not totally back to normal.   Some irritability in the past few days but otherwise in her usual state of health. Complaining of pain but no focal symptoms.
Fever, chills, vomiting, aches.  Primary recurring event is pain and heaviness in hips and back which started the day after the second dose of the vaccine. I have mentioned it to my doctor but have not yet sought treatment.
pt recv vax 6OCT95 & the same day pt exp swelling @ inj site extending down arm below elbow, skin was almost translucent;pt denied getting bitten by anything & arm was extremely sore;
Besides arm pain that went to my pinky, I was fine. Later that night, I started to get chills and was really cold. The next day, I developed a fever of 100.2 and was really cold. For about a week, I would be fine during the day and would get really tired by the evening and extremely cold. I also started feeling tightness in my chest about 2 days after I got the vaccine. I contacted my doctor and she told me to take Tylenol and Albuterol.
no adverse effect reported; a 12 year old patient received PEDVAXHIB; This spontaneous report as received from a Nurse refers to a 12-year-old patient of unknown gender. No information was provided regarding the patient's medical history, concomitant therapies, concurrent conditions and previous drug reactions.     On 15-AUG-2019, the 12-year-old patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) (dose, frequency, lot#, expiry date and indication was not reported) for prophylaxis (product administered to patient of inappropriate age). No adverse effects were reported. No product quality complaint was reported.    The outcome of product administered to patient of inappropriate age and no adverse event was unknown.
Dizziness, Seizures, Syncope, Bradycardia, cold, clammy Narrative: 10 mins after administration, Employee began expressing lightheadedness, Employee assessed, employee was cold and clammy. Employee then began to have a seizure which last approx 30 sec. Vital signs assessed BP 110/80 HR 87 then dropped to 50 which is unusual for employee. o2 sat 94% on room. Employee regained consciousness and was able to state name, time and place. Reported no previous history of seizures. Employee handed off to ER staff for further eval.
Pt developed immediate skin redness, warmth and scattered red welts that erupted after IPV given. Pt became irritable. There was no respiratory distress noted. Vital signs remained stable. Pt referred to MD for evaluation.
Pancreatitis; Flank Pain; Allergic reaction; Abdominal Pain; Pain; Rash; This spontaneous case was reported by an other health care professional and describes the occurrence of PANCREATITIS (Pancreatitis) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products IBRUTINIB (IMBRUVICA) capsule for Chronic lymphocytic leukemia and SEMAGLUTIDE (OZEMPIC) for an unknown indication.    Concurrent medical conditions included Chronic lymphocytic leukemia. Concomitant products included DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA), EMPAGLIFLOZIN (JARDIANCE) and METOPROLOL for an unknown indication.   On 20-Dec-2017, the patient IBRUTINIB (IMBRUVICA) (Oral) dosage was changed to 140 milligram once a day. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form, IBRUTINIB (IMBRUVICA) (Oral) 280 milligram once a day and SEMAGLUTIDE (OZEMPIC) (unknown route) 1 dosage form. On an unknown date, the patient experienced PANCREATITIS (Pancreatitis) (seriousness criterion medically significant), FLANK PAIN (Flank Pain), HYPERSENSITIVITY (Allergic reaction), ABDOMINAL PAIN (Abdominal Pain), PAIN (Pain) and RASH (Rash). At the time of the report, PANCREATITIS (Pancreatitis), HYPERSENSITIVITY (Allergic reaction), ABDOMINAL PAIN (Abdominal Pain), PAIN (Pain) and RASH (Rash) outcome was unknown and FLANK PAIN (Flank Pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: negative (Negative) Negative.     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.   Treatment information was not provided.  Company comment: Very limited information regarding this events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Patient notified RN after his 15 minute observation time and said he was feeling woozy. Blood pressure and heart rate obtained. 181/108; 80. Patient then notified RN lead of clinic who spoke with patient. Patient stated he felt "fuzzy all over".  Encouraged patient to go to ER. Nurse lead got wheelchair and notified wife. Patient was escorted via wheelchair to ED by RN.
some of the vaccine oozed out; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (some of the vaccine oozed out) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Sep-2021, the patient experienced ACCIDENTAL UNDERDOSE (some of the vaccine oozed out). At the time of the report, ACCIDENTAL UNDERDOSE (some of the vaccine oozed out) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Rapid pulse, felt like she was going to pass out. Took Metoporol and returned to normal.
ARM SO SORE, COULD HARDLY LIFT IT BY EVENING TIME, AND LOW GRADE FEVER OF 99.5.
Pt stated he was very anxious about getting vaccination.  Immediately after the administration of the Hepatitis A vaccine he stated his vision was getting blurry and his color became pallor.  Pt was sitting and lowered his head for a few minutes on instruction.  He remained conscious and then raised his head up. His hands were shaky. Pt was given some water to drink and then some cola to drink.  He stated he felt better and remained seated for about 20 minutes.  His father was with him and was going to drive him home.
Day 1 and 2 ...sore arm. Nothing until Day 8. On Day 8 a light pink splotch ( 3inX2in) at site if injection. VERY itchy and a bit swollen.
Information has been received from a nurse practitioner concerning a 15 year old female who on 24-JUn-2008 was vaccinated with the first dose of GARDASIL 0.5 ml IM. Concomitant therapy included HAVRIX and ADACEL. On 24-JUn-2008 the patient experienced lethargic for about 24 hours after vaccination. Subsequently, the patient recovered from lethargic for about hours. The patient sought medical attention and called office. Additional information has been requested.
Pt recvd Pneumovax 23 on 08OCT90; Later that night, pt exp tender clavicular mass w/swollen tender arm; Seen in ER & mass was noted to be a swollen lymph node, devel fever, myalgia, diarrhea & hospitalized; 15OCT90 lymph nodes found again;
3 days post vax, pt experienced the first varicella lesion. Within 4 days the pt experienced full blown chickenpox that was diffuse and generalized with greater than 50 lesions. The pt also experienced urticaria.
Redness at site, size of apple swelling at site fever at site Ice applied to site, APAP administered PO
BECAME 2 BUMPS/AND NOW HAD MORPHED INTO 1 BIG SWOLLEN MESS AN INCH AND A HALF IN DIAMETER; GOT ARE AND SWOLLEN/BIG SWOLLEN MESS; This spontaneous report received from a patient concerned a 60 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced became 2 bumps/and now had morphed into 1 big swollen mess an inch and a half in diameter. On APR-2021, the subject experienced got are and swollen/big swollen mess. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the got are and swollen/big swollen mess and became 2 bumps/and now had morphed into 1 big swollen mess an inch and a half in diameter was not reported. This report was non-serious.
Slightly raised and itchy rash on neck and chest; Extreme arm pain that went into shoulders; Couldn't lift arm arm and having mobility issues at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Couldn't lift arm arm and having mobility issues at injection site), RASH (Slightly raised and itchy rash on neck and chest) and VACCINATION SITE PAIN (Extreme arm pain that went into shoulders) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history not provided.).    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Couldn't lift arm arm and having mobility issues at injection site) and VACCINATION SITE PAIN (Extreme arm pain that went into shoulders). On 14-Mar-2021, the patient experienced RASH (Slightly raised and itchy rash on neck and chest). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Couldn't lift arm arm and having mobility issues at injection site) had resolved and RASH (Slightly raised and itchy rash on neck and chest) and VACCINATION SITE PAIN (Extreme arm pain that went into shoulders) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment included ibuprofen and a hot water bottle on the affected arm.   This case was linked to MOD21-056849 (Patient Link).
Dose 1 sep 12th 2016, dose 2 June 21st 2021; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 15-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA415A, expiry date 30th September 2021) for prophylaxis.   Previously administered products included Menveo (received 1st dose on 12th September 2016).   On 21st June 2021, the patient received the 2nd dose of Menveo. On 21st June 2021, unknown after receiving Menveo, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 16-AUG-2022 Reporter's Comments: This case was reported by a healthcare professional. The reporter stated that the patient received 2nd dose 8 days earlier before his 16th birthday. The reporter stated that as per school requirements, school does not accept it, as it says its 8 days before his 16th birthday. The adverse event was filed because they gave it too early based on school requirements. The reporter consented to follow up. Additional Supportive Information: The patient received 2nd dose of Menveo, which led to extra dose administered.
I developed Bells Palsy .....left side of face.  Tinnitus in right ear.  AFTER 2ND VACCINE>.  I have had  for 5 days and hoping for a full recovery.
Throwing up; hot area on arm; couldn't move left arm; very anxious; very sick feeling.
Small hard and painful bump on her left side at the base of neck, approximately the size of a dime Narrative:
Patient started complaining of becoming very hot/over heated and showed slight signs of a mild seizure. Unresponsive for around 10 second and eyes rolled back into her head. Patient came to and then she became unresponsive again and eyes rolled back into her head once again for around 10 seconds. Patient woke back up and then vomited several times. Patient was fine afterwards. EMS was called to check vitals.
Shot given 1/28/15 (R) deltoid. Pt to clinic with c/o arm being numb 1/30/15. Has ganglion cyst wrist of same arm that she states gave similar sx with injection. No redness, induration, swelling on exam today. FROM. Nl. circulation.
fever; body aches; felt sick after her first dose of the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "she had COVID" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; PAIN (non-serious), outcome "unknown", described as "body aches"; ILLNESS (non-serious), outcome "unknown", described as "felt sick after her first dose of the vaccine".  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
feeling a little nauseous; bitter taste back of mouth; felt unwell; sore arm; racing heart; tachycardia; BP 220/110; anxious; a-FIB; crazy heart rate; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration administered in the left arm on 05Mar2021 02:15 AM (lot number EN 6205 (also reported as or ENG205?) as a single dose for COVID-19 immunization. Medical history included high blood pressure 18 yrs, controlled and allergy to cats. Concomitant medication(s) included diltiazem; acetylsalicylic acid (ASPIRIN); magnesium; vitamin B complex (B COMPLEX); and ascorbic acid (C-VITAMIN) (received within 2 weeks of vaccination). 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 has not been tested for COVID-19. The shot went fine around 2:00 p.m. that afternoon. On 07Mar2021 12:15 PM, the patient experienced feeling a little nauseous, bitter taste back of mouth, felt unwell, sore arm, racing heart, tachycardia, BP 220/110, anxious, A-Fib, and crazy heart rate. The adverse events resulted in emergency room/department or urgent care (went to ER at 48 hrs after shot) and was hospitalized (admitted) for 2 more days from Mar2021 to Mar2021 (no. of days hospitalization was 2). About four or five hours later feeling a little nauseous, bitter taste back of mouth. Woke 12 hours later, very sore arm. Day 2 just felt unwell, Nausea, taste, day 3 still unwell, breathing, racing heart. BP 220/110, a-FIB, tachycardia, release day five. Day 7 felt normal. Day 9,10 crazy heart rate for a few hours. Day 18 2AM-6AM went into a-FIB. Very anxious now. Day 20 again wake up with Afib /Tachycardia for 2 hours. Scared to get the second shot. The patient heard that he could possibly get the Johnson & Johnson as his number 2. Treatment was received for the adverse events including unspecified medications and liquids. The outcome of the events was recovered with sequelae on Mar2021.
Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: injection site immediately became a hard knot and red and hot. ice give to pt and observed for 30minutes, rxn did not progess any further. advised pt of emergency protocol and told we will f/u with her tomorrow since we are closing in 30minutes after she left
Patient states that he was fully vaccinated for COVID with Moderna vaccine in March.   we do not have his vaccine information on file, but he will be emailing us a copy of his COVID vaccination card when he finds it, and you may contact his PCP  for the relevant information on the card.)  He was exposed to someone with COVID on 07/12, developed symptoms of COVID on 07/12 and tested positive for COVID on 07/16.
GIB (gastrointestinal bleeding). ED visit to hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
Painful mouth sores erupted on back of throat 2 days after vaccine. Extreme sore throat.  Sores and fatigue lasted for 10 days after shot.