chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist and described the occurrence of high blood sugar reading in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date in October 2010 the subject received a dose of FLULAVAL (details unknown). Less than one week after vaccination with FLULAVAL, the subject experienced high blood sugar readings. At the time of reporting the outcome of the event was unspecified. No further information was provided.
Arm was red, swollen, hurt to move. Low grade temp. Advised anti-inflammatories, antihistamines, cold compress and office visit the next day to follow-up.
Mother presented child to clinic. Complained that left lateral thigh swollen. Noted to be swollen, moderately red with heat.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history was not reported. In 2015, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscular for prophylaxis. On 24-OCT-2018, the patient received another dose of PNEUMOVAX 23 lot # R012976, expiration date 25-JAN-2020 intramuscular for prophylaxis. No adverse effects were reported.
Redness on L upper arm that started after getting Pneumonia vaccines on 07/16/15. Pt says it felt "like it didn't go in as deep as other vaccines". Now having redness and mild itching below the injection site. No f/c. Minimal pain. Local reaction to pneumococcal vaccine - appears to have extravasated fluid subcutaneous instead of the fluid going IM and now having localized reaction. Outlined area in permanent marker. Instructed pt to use triamcinolone cream that she already has to help calm down reaction. Rtc if red area is increasing in size or any f/c or worsening of symptoms.
Pain and stiffness at injection site and whole arm Headache  Chills Took Tylenol.  Tried to keep as much movement arm as possible.    This morning only symptom is soreness at injection site
Redness, swelling, hot, and painful to touch at the injection site. Symptoms started within 12 hours od second vaccine dose. Narrative:
After vaccines were given, Pt. turned pale & stiffened arms & legs & eyes rolled up after last vaccine was given. Lasted few seconds. Had lower heart rate, but responded to stimulation. Pt. send out for blood test and chest X-ray.
Left thigh 2.5x1.5 cm red, indurated, warm, observe x 24 hours if redness and warmth persists, to start Keflex 250 mg po bid x 7 days. 24x48 hours after ABXs start or sooner if worse.
Following administration of Influenza vax, pt devel pain & swelling w/redness @ inject site; sx lasted for 2 days;
About 3 days after vaccine I started having severe headaches. After 9 days of the headaches I went to see my doctor. I no longer have the severe headaches now I'm having a lingering low level headaches and fatigue.
Lips started burning, tongue started, lost taste buds, throat drying/Basically an anaphylaxis but my throat did not close up; This is a spontaneous report received from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 01May2021 11:15 (Batch/Lot Number: EW0172) (at the age of 67-year-old) as 2nd dose, single for covid-19 immunisation. Medical history included heart, hashimoto, high cholesterol, fibromyalgia and allergies. Concomitant medication(s) included levothyroxine sodium (SYNTHROID); amitriptyline (MANUFACTURER UNKNOWN); carvedilol (MANUFACTURER UNKNOWN); clopidogrel (MANUFACTURER UNKNOWN); all taken (received within 2 weeks of vaccination) for an unspecified indication, start and stop date were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 administered in Arm Left on 10Apr2021 11:15 (Batch/Lot Number: EW0162) for covid-19 immunisation and had no adverse event. 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 01May2021 20:00, the patient lips started burning, tongue started, lost taste buds, throat drying. Basically, an anaphylaxis but my throat did not close up. The seriousness criteria were considered as non-serious. No treatment was given for the events. The outcome of the event was recovering.
Patient was given vaccination earlier than indicated date. Patient's first vaccine was done 11/24/2021 and she was given her second injection on 12/8/2021.
ITCHING IN BOTH EXT. AND LIPS.  1655 PT TAKEN TO EMERGENCY DEPARTMENT, IV NORMAL SALINE BOLUS, BENADRYL 25 MG IV, ALLEGRA 180 MG BY MOUTH GIVEN. PT WAS DISCHARGED HOME WITH FAMILY WITH  INSTRUCTIONS TO INCREASE FLUID INTAKE. TAKE OTC ALLEGRA 180 MG EVERY DAY AND BENADRYL 25 MG EVERY 4-6 HOURS AS NEEDED FOR ITCHING OR RASH. NO DRIVING FOR 12 HOURS AND RETURN TO ED IF CONDITIONS WORSEN.
Mom Passed away last Tuesday; This is a spontaneous report from a Pfizer from a contactable consumer reported (patient's child). A female patient of an unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported.  Patient passed away on an unspecified date in Apr2021 (reported as last tuesday). It was reported that patient's child and entire family were scheduled to get second dose of Covid Vaccine on 29Apr2021. Clarified that they tested postive after first (1 st) dose. Patient (Mom) passed away last Tuesday. She was wondering about getting the second dose. The patient died on an unspecified date in Apr2021.  It was not reported if an autopsy was performed.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Mom Passed away last Tuesday
Soreness at injection site 12/7/16.  At 3:30 AM on 12/8/16, she woke up with pain at the injection site that radiated up her shoulder to the base of her skull.
nurse given a patient one component from the Pentacel and not the other, no AE; Upon second medical examination of the case during internal review, a significant correction was performed on 04-Oct-2019 to update correct validity of case from non-valid to valid.  Initial information received on 19-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a patient who was vaccinated with one component of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Batch number, expiration date, dose, route and site of administration was not reported) and not the other and not certain if that was the HIB portion or the DTAP IPV portion, on an unspecified date.  It was an actual medication error due to inappropriate reconstitution technique.  At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Follow-up information received on 09-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  No new information was received.  Addendum: 19-Aug-2019: The validity was corrected.  List of documents held by sender: none.
Had 16 Lymph nodes removed from the groin area about a year ago due to cancer surgery.  There was some swelling around the upper right thigh area before the shot, but was under control.  After the shot swelling increased and could see a noticeable difference by the 16th.
DVT leg leg: leg pain started around 3/24, then he developed swelling on 4/2 and a DVT was diagnosed on 4/3. He had been on Xarelto 10 mg daily for history of recurrent DVT (had never had one while on anticoagulation) at the time this was diagnosed.
First dose / on November 19th 2019 / second dose has not been received yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 19th November 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The pharmacist reported about the late 2nd dose. The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up. The vaccine administration facility was the same as primary reporter. Lot number and expiration date of the vaccines were not provided.
pt states the she woke up at 3:30 with cold sweat and chills , then went into a full body flush, lasted for 1 hour, she then fell in and out of sleep, when she got up a few hours later she was clammy. her first 3 vaccine where Pfizer, this is her first Moderna. she did have covid 06/30/2022. Nurse states it could be a response to the vaccine and resent covid infection where the body was reacting to the vaccine. patient was told to rest and stay hydrated.
2-10-09 MMR & VARICELLA given. 2-11-09 PC from mom. States child "broke out" in rash at babysitters. RN advised parent to take child to Dr. advised mom to phone HD with results - PC to home 2-11, 2/15/09 x 4 - No answer - Letter sent 2-17- no response. Outcome unknown. Follow-up Information 17-MAR-2009: Our office has not heard any more information or contact from parent.
Patient received her second Pfizer dose 15 days from the first Pfizer dose, she was supposed to have 21 days in between.
Patient's wife called and stated patient had redness of arm, fever of up to 103 degrees, chills and aches from evening of 11/28/2016 until the time she called on 12/02/2016.  She stated they were going to urgent care for further evaluation.
94-year-old female from a nursing home normally A&O x4 and active, who has had altered mental status x2 days, poor p.o. intake and fever.   History is limited due to mental status.  History is gathered from chart review.  Patient has been in rehab following a femur fracture in late December.     In the ED she was noted to have a temperature of 101.7 and a heart rate in the 120s.  Has not been hypotensive or hypoxic.  She received a liter of fluids. Chest x-ray did not have any infiltrate.  CT of the head showed atrophy but no acute findings.  She has a chronic stable anemia.  Renal functions are normal.  No increased work of breathing and normal pulse oximetry.   Clinical Summary Patient did not require supplemental oxygen with her covid infection.  Patient improved with scheduled acetaminophen and patient is essentially back at baseline although weak.  Patient did not start on paxlovid as she is unable to swallow, but it was decided that with her improvement without it, she will not start therapy.  Family noted that patient was not taking her nightly percocet for pain and does not seem to be in pain and due to bad dreams at night, percocet will be discontinued on discharge and it was recommended that patient takes acetaminophen q6hr PRN for pain, and scheduled short term if needed.  Patient's potassium was replaced for hypokalemia and c diff was negative for her diarrhea.  Patient will be discharged back to the nursing home to continue quarantine.   Discharge diagnosis COVID-19 Encephalopathy Diarrhea Hypokalemia Anxiety A-fib Hypertension HLD Hypothyroidism Chronic hyponatremia Metabolic Encephalopathy Sepsis due to Covid 19, POA Severe malnutrition with cachexia POA
pt recvd vax & 15 mins later exp flushing & lightheadedness; also exp chills, mild fever, weakness all over, nausea & trembling; treatment APAP & DPH;
Patient was given a BIvalent dose of Pfizer COVID vaccine in lieu of Monovalent for second dose in series.  Provider, parent, manager and immunization registry were all contacted.  No adverse reactions noted.
Pt was admitted on 6/7/22 for skilled nursing care and therapies s/p hospital stay for lewy body dementia, falls and decline in function. He is followed by mental health and Seroquel was increased recently due to increased combative behaviors during care. Continues to be restless at times. Has had a decline in eating/intake since admission. Has been seen by palliative care. Discussed care needs and decline with daughter during meeting-daughter expresses goal of comfort for her father. Hospice referral was completed and patient admitted to Hospice servives 6/24. Ongoing continued decline, refusing meds, meals and fluids related to progressive LB dementia. Passed away on 6/28/22 at 12:43pm
After receipt of dose 1 noticed a couple of episodes of intense tinnitus. After a few days the symptoms disappeared. Did not report. Upon second dose, several episodes of intense tinnitus reoccurred. The first event was within an hour of receiving second  dose. Tinnitus continues to varying degrees, but not entirely absent. No treatment to date. Audiology referral pending.
This spontaneous report was received from female patient with egg allergy and hay fever and no pertinent medical history who on an unknown date was vaccinated with a dose of PNEUMOVAX23 (dose, lot # and, route were not provided). No concomitant medications were provided. The consumer reported that while in her physician's office she received a dose of PNEUMOVAX23 and had an allergic reaction. She stated she believed her doctor gave her a shot of adrenaline for the reaction. The attending physician held her at the office for about 8 hours for observation. The consumer could not recall when she received PNEUMOVAX23. No laboratory tests were performed. At the time of the report, the patient had recovered from the event of allergic reaction to PNEUMOVAX23. The relationship between PNEUMOVAX23 and the event was not reported. The consumer also reported receiving a similar reaction to an unspecified flu vaccine (manufacturer unknown) (MARRS number 1210USA012188). Upon internal review, allergic reaction treated with adrenaline was considered to be another important medical event. Additional information has been requested.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive for Covid after completing paxlovid and testing negative; Negative, notes: Tested positive for Covid after completing paxlovid and testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.T he patient received other medication in 2 weeks was reported as No. COVID 19 Treatment with Paxlovid from 26May2022 to 31May2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
12 hours post injection of Td, developed a fever (103) with chills et generalized body aches.
arm only hurt a little; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm only hurt a little) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No medical history was reported.    On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm only hurt a little). At the time of the report, PAIN IN EXTREMITY (arm only hurt a little) outcome was unknown.            No concomitant medications were provided. No treatment drugs were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-067505 (E2B Linked Report). This case was linked to MOD-2021-067505 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067505:
Night of vaccination child developed swelling and redness at site of DTaP.  Noted to have generalized urticaria worsening over 2 days until taken to ER and given oral steroids.
Got the vaccine in the evening.  The following morning I had a fever of 102, hurt all over, had to leave work due to extreme nausea (did not vomit).  Continued having pain across my shoulders for weeks afterwards.
No adverse events after immunization.  Gave DTaP, dose #4 3 1/2 weeks too soon.  4/17/08 No reactions after talking with mother.
I had continual chest pain and HBP for about 4 months I had to get on BP meds for first time in life. Lisinopril with HCTZ and take daily aspirin . My son got myocarditis and was seen in ER after his 3rd shot, my mother's BP also skyrocketed after her 3rd. Will have them fill out a report as well.
Patient is a 60 y.o. female with PMH sifnificant for DM-2, fibromyalgia and OSA who presented with left upper quadrant abdominal pain and increased cough.  The patient was diagnosed with COVID on home test on 05/20/2022. The patient did have cough, malaise and body aches for 3 weeks and then her symptoms improved.  Her cough started again 5 days prior to admission. CT abdomen and pelvis showed left basilar pneumonia with small abscess. Lower esophagus slightly patulous with fluid.  Greater than expected prominence of intrahepatic bile ducts with out convincing evidence of gallstones or more distal common bile duct dilation Right middle lobe 6 mm nodule.  CMP was unremarkable. CBC with WBC 12.8 hemoglobin 13.1 platelets 488. CT chest with IV contrast showed extensive multifocal consolidation bilaterally concerning for pneumonia. 16 mm left lower lobe collection concerning for abscess.  Necrotic malignancy cannot be entirely excluded.  Small left pleural effusion bilateral hilar lymphadenopathy.  Patulous esophagus.  Patient was given azithromycin, Rocephin and vancomycin and transferred to Hospital for further evaluation and management.   At the Hospital, the patient was given IV Zosyn, vancomycin and azithromycin for pneumonia.  Pulmonology was consulted and they recommend to continue IV antibiotics. MRSA screen was negative. IV vancomycin was stopped on 6/17/22. She was continued on zosyn as a single agent from 6/15 to 6/20, Pulmonary recommended another 4 weeks off Augmentin 8 incentive 5 mg orally 2 times a day.  Her sputum grew yeast which pulmonary thought was a contaminant.   She was noted to have an elevated gamma gap. A select workup for myeloma and with quanitative IgGs was perfomed to evaluate further and will need to be followed up as outpatient. The pulmonologist recommended an x-ray chest with PCP in 1 week to again evaluate for effusion, if present it will need to be tapped.  Otherwise the patient can undergo noncontrast CT of the chest through PCP in 2-3 months to ensure a 16 mm fluid collection is resolved with treatment.  The patient was recommended to stop smoking, counseling was done, nicotine patch were prescribed at the time of discharge. The patient did not require oxygen at the time of discharge did very well and was subsequently discharged home.
19 patients received an expired booster; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (19 patients received an expired booster) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (19 patients received an expired booster). On 30-Nov-2021, EXPIRED PRODUCT ADMINISTERED (19 patients received an expired booster) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided.
Diagnosed with Guillain Barre Syndrome. Extreme tingling in fingers and toes that would not go away and became more painful in the evening.
Information has been received from a physician concerning a patient who was vaccinated with the first two doses of Gardasil.  Subsequently the patient experienced abdominal pain and dizziness after each dose.  The side effects were ceased but no time frame was provided.  The patient will not be receiving the third dose.  Unknown medical attention was sought.  The patient recovered.  No product quality compliant was involved.  Additional information has been requested.
The pt experienced urticarial rash over joints and the progressing to trunk. The pt also experienced erythema multiforme.
Malaise 3 days, Fatigue 3 days, Headache 3 days, Injection soreness 4 days
temp 100.8, headache, muscle aches, joint aches, sore throat, swollen glands, red rash on arm of injection site
Patient started having injection site pain that got worse by the day, with pain radiating to her back area.  She went to see her primary doctor on 2/5/20 and on 2/7/20 and they examined her, got her EKG and x-ray.  Nothing abnormal came out from  both screening tests.  She was then referred to emergency room as the primary care was unable to give further treatment for the pain.  She received muscle relaxants and pain meds (oral & topical) but stated that no medication (oral or topical) is helping to relieve pain.
On night of the day after administration (about 30 hours after administration), area of injection became red, swollen and itchy.  States at that time area was "larger than a quarter."  Today returned to our site (48 hours after immunization).  The site, which is reddened, swollen and warm to the touch, measures 7cm x 9.5cm.  C/o itching in area.  Denies fever, nausea, pain.  Denies allergies except for hay fever.  Has not taken any medications.  States that as a child she remembers having had chicken pox; however, when varicella titer was drawn for school requirement, titer was "low" and school told her to receive Varicella Vaccine.  We instructed patient to purchase and take benadryl tablets and to SMA if area worsens or if she feels worse in any way.
Hyperventilating. Extreme dizziness.  Blacked out. Went to emergency room at hospital.  Still have constant dizziness and effects from motion. Confusion and thoughts, motor skills slower.
Today patient presented to pharmacy with large red/pink area surrounding the injection site. Patient stated that it started with pain and then a bump and then the redness spread. The redness was from the shoulder down to the elbow. The site was warm to the touch. Got in touch with our clinical director and showed a picture of the reaction informed patient to go to urgent care. Patient has been icing and said is looking better and will wait before going to urgernt care.