chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE reported; a dose of GARDASIL 9 was administered following a temperature excursion; This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age or gender. No information was provided regarding the patient's pertinent medical history, concurrent conditions, concomitant medication, and drug reactions or allergies.  On an unknown date, a temperature excursion involving HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (lot number T030746, verified as valid for syringe formulation, with an expiration date reported and validated as 16-MAR-2023) occurred. The HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was improperly stored at a temperature of 49.69 degrees Fahrenheit for 1 hour and 24 minutes. There was no previous temperature excursion, and this was called because of a data logger. On 19-JUL-2021, following the temperature excursion, a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was administered to the patient for prophylaxis (administered dose, dose number, vaccination scheme frequency, route of administration, and anatomical location of vaccination were not reported) (product storage error). No additional adverse events (AE) were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T030746; expirationdate: 16-MAR-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Patient states that in addition to feeling nauseous and weak, he developed 2 pustules on his abdomen that were small and fluid filled. They completely resolved within 48 hours (by his best estimate).
burning mouth Syndrome, got worst after the booster; 3 ulcers on his tongue after the booster; Speech has been affected after the booster/"I speaks like a person whom had a stroke." after booster; The Back of the tongue is black/ dark; This spontaneous case was reported by a patient and describes the occurrence of BURNING MOUTH SYNDROME (burning mouth Syndrome, got worst after the booster), TONGUE ULCERATION (3 ulcers on his tongue after the booster), SPEECH DISORDER (Speech has been affected after the booster/"I speaks like a person whom had a stroke." after booster) and TONGUE DISCOLOURATION (The Back of the tongue is black/ dark) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2022, the patient experienced BURNING MOUTH SYNDROME (burning mouth Syndrome, got worst after the booster), TONGUE ULCERATION (3 ulcers on his tongue after the booster), SPEECH DISORDER (Speech has been affected after the booster/"I speaks like a person whom had a stroke." after booster) and TONGUE DISCOLOURATION (The Back of the tongue is black/ dark). At the time of the report, BURNING MOUTH SYNDROME (burning mouth Syndrome, got worst after the booster) had not resolved, TONGUE ULCERATION (3 ulcers on his tongue after the booster) and TONGUE DISCOLOURATION (The Back of the tongue is black/ dark) was resolving and SPEECH DISORDER (Speech has been affected after the booster/"I speaks like a person whom had a stroke." after booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy tongue: did not find anything.         No concomitant medications were reported. In Mar-2022, patient had received the booster dose. The patient had 3 blisters on tongue and the doctor did biopsy of tongue blisters but they did not find anything. The tongue still burned all the time, he had dry mouth.  Treatment included Magic mouthwash (twice with different formulas).   This case was linked to MOD-2022-614412 (Patient Link).
Flu like systems; Headache; Body aches; Fatigue; Nausea; Painful arm; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Eng6203) via an unspecified route of administration in the right arm on 03Mar2021 at 07:45 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The medical history included diabetes, fibromyalgia, allergy to opioids and the patient was a breast cancer survivor. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The concomitant medications included metformin (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), losartan potassium (LOSARTIN) and atenolol (MANUFACTURER UNKNOWN), all from unknown dates for unknown indications and unknown if ongoing. The patient previously received tetracycline (MANUFACTURER UNKNOWN), morphine (MANUFACTURER UNKNOWN) and amoxicillin/clavulanic acid (AUGMENTIN) and experienced allergy. On 03Mar2021 at 13:00, the patient experienced flu like symptoms, headache, body aches, fatigue, nausea and painful arm. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events flu like symptoms, headache, body aches, fatigue, nausea and painful arm was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
C/O feeling like her BP was high, had patient first drink water and lay down, then sent her to ED, they transferred her to hospital for admission.
Acquired shingles within a week after and am on chemotherapy for multiple sclerosis.; This is a spontaneous report from a contactable consumer (patient). A 41-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Lot Number: ER8730) via an unspecified route of administration on 22Mar2021 at 09:45 (at the age of 41-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included multiple sclerosis and trigeminal neuralgia, both from unspecified dates and unspecified if ongoing. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 the patient experienced acquired shingles within a week after and am on chemotherapy for multiple sclerosis. The event required treatment with doxycycline and Valtrex. The clinical outcome of the event acquired shingles within a week after and am on chemotherapy for multiple sclerosis was recovering/resolving. Since the vaccination, the patient has not been tested for COVID-19.
Itching, redness, rash on torso, legs and arms, but not at vaccination site. Also stated was slight coughing.
Continued pain in upper left arm where given the shot.  Never had pain there before until given the shot.  Pain sometimes wakes me up at night.  No pain in right arm.  Is difficult to get dressed in the morning and loss of strength in the upper arm.  Pain started day after the shot in upper arm and has not gone away.   Is tender to the touch at the location the shot was given in the arm.
Drooping of face on right side to include jaw line and right eye, running watery right eye - Diagnosis: Bell's Palsy
Fri 2/5/21 , 6 am teeth chattering, weak, nausea, tiredness, slight headache, light headed, extreme diarrhea (may be due to antibiotic) very slight soreness as injection cite.   This lasted for 48+ hours.  Did not feel myself for  72 hours.
first pain and knot hardness at injection sight on left arm within 3 hours.... swelling and large whelp the size that my right hand couldn't cover.... there was  a little dizziness and weird vision''' fever for 3 days and I felt just like I did when I had COVID in Dec-Jan ...on the third day the armpit at breast was swollen   tylenol and motrin were taken for fever and  and ice packs  applied for soreness and swelling also lots of fluids  I DO NOT want to feel like  i have COVID again!!!!! this was as rough as when I had it but only lasted 3 1/2 days instead of the 3 weeks when I had it before
student pharmacist gave undiluted Pfizer Bivalent Kids 5-11 orange cap vaccine 0.3mL to adult patient. Contacted Pfizer medical information where attendant said that undiluted kids bivalent 5-11 orange cap vial is at a concentration of 130mcg/1.3mL and 0.3mL would essentially be the adult dose so patient is ok but has caused us to install extra safety measures for our student pharmacists moving forward to ensure this does not happen again
Near syncope after immunization, slumped to floor. BP 84/58. Episode lasted about 3 minutes.
Breakthrough case admission after 3 vaccines  Moderna 2/4/21 Lot# 013M20A;  Moderna 3/4/21 Lot# 030A21A;  Moderna 11/9/21 Lot# 027C21A
My son have two knot very  swollen and red around the shot site in his two arms and fever 100.7 for two days. It wont go away wit tylenol or motrin .we had to used both
11:56 AM Patient stated "I am afraid of needles." Nurse used distraction and slow breathing technique to help patient overcome apprehension of needles. Observed patient for 15 minutes with no signs and symptoms of adverse reaction. Patient stated "I feel fine." Patient went back to work. Approximately 12:30 PM patient returned with complaint of dizziness and nausea. Nurse assessed patient vital signs: BP 118/75, pulse 70 ans 2+, PERRLA, respirations 17 normal and non-labored. Patient denies and SOB, pain, dyspnea. Lung sounds clear all fields, no wheeze or stridor noted.
Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were unknown. On unspecified dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 (dose and route unknown, lot# L018503, expiration date: 16-MAR-2017). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
03/27/15 red bump at injection site with a headache, 03/30/15 mild nausea and headache, eyes "puffy underneath".
Fever onset 5 pm Wednesday, Thursday, Friday went to ER and was admitted IV fluids were given.
Erythematous swelling approximately 5cm on left thigh; non-tender. 12/18 Visit to urgent care for reaction.
Pt. woke up on 6/26/11 w/redness & small blisters around injection site. Then 06/29/11 she developed a couple large blisters under arm where injection was given. Contacted Merck (guidelines) told pt to contact primary care physician. Pt. described as itchy. It did not hurt.
The patient is 29 yo healthy female who received anthrax #6 on 25 Sep 2015 (BIOPORT #FAV402A) to her (R) arm, typhoid #4 (GSK lot # K11831) and polio IPV 25 (sanofi Pasteur lot # E02041) to her left arm. She reports she developed pain, pruritus, edema and erythema to her right upper arm, and wants to know if this is normal. The symptoms started approximately 24 hours after vaccine receipt and have continued to worsen. She treated it with ice and topical hydrocortisone. Per p/e (R) upper arm with mild edema compared to left and 8x10 cm patch erythema, with increased warmth to medical aspect, nontender. Distal fingers with normal strength, ROM and brisk capillary refill. P: continue ice, cetirizine po q12 prn and topical triamcinolone.
Narrative: 101 yo male patient who resides at senior living facility & does not receive facility care died on 5/26/2021. Pt had received covid vaccinations from the facility where he resided on 12/30/21 & 1/20/21. No information provided on the cause of death. Likely covid vaccinations not related to death given 4 months death post last vaccination.
Within 12 hours, hard lump at the injection site.  Followed by very red lesion (1.5+ inches by 2.0 inches - measured this after it was going down - took picture)  Arm swelled.  Arm became red like a rash  around the lesion.  Entire arm and shoulder in pain .   Took a week for it to go down.  Injection site still very sore.  In addition, felt like something was sitting on my chest during this time.
I had an accident in the kitchen with a knife and cut my finger on 2/8/05, I recieved stitches and a tetanus shot that same day.  Within 1-2 weeks I had severe back pain.  The back pain was severe enough that I went to an urgent care center and the ER on two seperate occasions.  I also went to the student health center and started going to the Physical therapy department on my college campus as well.  While dealing with the back pain, I began experiencing fatigue, muscle soreness, severe hot and cold flashes, headache, numbness and tingling, poor coordination and balance, I could not lift my head (it felt like there were bricks stacked on top of it), bowel problems, there is a black spot in my line of vision (still), and I also got bells palsy.  I was placed in the hospital for two days and one night for observation and testing.  I was put on vicodin, which did not help at all, and given a shot of demerol in the ER for the back pain.  During the PT the extreme pain in my back got better and then I was left with all of the other symptoms and just a pain in my back that was annoying but not excrutiating.  While in the hospital I was put on a steroid for the bells palsy.  After I was released the doctors basically said that they had no idea what was wrong with me, they hope I continue to get better and it must have been the tetanus shot based on my history.  This happened to me as a child at the age of 12 or so.  I fell and got a bad cut on my head, recieved stitches and a tetanus shot.  At that time my parents were told that I had Encephalitis.  I had to quit school, quit my job and could not care for my family.  I feel better now but that black spot is still in my line of vision and I am "absent minded" much more than normal.  Whether this is something to worry about or not, I will find out when I start school again this coming Fall semester.
Arm was very sore for several days.  6 days after injection -- upper left arm broke out in a red, itchy rash (12/28).  On 12/29 the rash is more spread out on the left upper arm and is lighter red.
pt recv vax 17OCT95 pt devel nausea,joint pain (shoulders,hips,knees),a swollen arm,h/a,& was itchy
Swelling with redness.  Size of baseball at injection site.  Warm to touch.  Ice bag, Benadryl, prednisone.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Dizziness / Lightheadness-Mild, Additional Details: PATIENT STATED SHE FELT LIKE IT WAS HARD TO SWALLOW AND THROAT WAS TIGHT. GIVEN WATER AND DIPHENHYDRAMINE 25MG AND MONITORED FOR 30 MINUTES AFTER. PATIENT WAS FEELING FINE WHEN LEAVING. CALLED 5 HOURS LATER AND PATIENT IS FEELING FINE AND NO SYMPTOMS.
Pt experienced flu like symptoms with temperature and joint and bone aches.  Then spotty rash 3 inch red spots Bells Palsy then sinusitis.  Pt was treated with Prednisone, eye ointment with antibiotics and Flonase for sinusitis.
I received. the second dose of the Pfizer vaccine on 3/28/21 (first dose on 3/7/21).  On the following Sunday, 4/4/21, I developed what I thought was a rash on my legs, but predominately on my left leg and forearm . The rash was red and purple spots, covering about 1/2 of my leg.  On Thursday, 4/7/21, I visited my PCP for a check.  He diagnosed the rash as purpura, most likely a result of my COVID vaccine.  In addition, he ordered a platelet count .  The platelet count came back as normal on 4/8/21 .   I have no underlying health conditions .
Urinary frequency, Rhinorrhea, 'heartbeat in her ears', headache, redness around ZOSTAVAX injection site.
patient  received a  2nd  booster shot   he received his 1st dose and booster was verified and received his 2nd booster today 05/09/22 at a location. Patient stayed for 15 mins observation with no obvious reaction noted.
Fully vaccinated with Moderna x 3 doses. Tested positive for Covid 19 on 02/04/2022. Admitted to Medical Center on 02/08/0222. Expired on 02/23/2022 while still hospitalized.
Moderna COVID-19 Vaccine EUA On April 12, 2021 developed a bump on buttocks, it grew and was inflamed and painful to sit on Left Buttocks. The bump turned into a sore so I called dermatologist to schedule an appointment. Those few days was feeling fatigued and felt a swollen lymph node on left side of groin.
Severe migraines, inlammation, blurring vision/spots, reaction to gluten/wheat. Weakness /fatigue/aching muscles and joints.
developed MERSA infection; affected his kidney; infection in his foot  due to the injury; This spontaneous case was reported by a consumer and describes the occurrence of STAPHYLOCOCCAL INFECTION (developed MERSA infection) and KIDNEY INFECTION (affected his kidney) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced STAPHYLOCOCCAL INFECTION (developed MERSA infection) (seriousness criteria hospitalization and medically significant), KIDNEY INFECTION (affected his kidney) (seriousness criteria hospitalization and medically significant) and LOCALISED INFECTION (infection in his foot  due to the injury). At the time of the report, STAPHYLOCOCCAL INFECTION (developed MERSA infection), KIDNEY INFECTION (affected his kidney) and LOCALISED INFECTION (infection in his foot  due to the injury) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided.  Treatment medication provided Antibiotics.  Patient stated that During his hospital stay, they flushed his body to get rid of MERSA and antibiotics from his blood.  Company Comment: This case concerns a 59-year-old male patient with no reported medical history who experienced the unexpected events of Infection MRSA and kidney infection. The events occurred on an unspecified date after the first dose of mRNA. The rechallenge was unknown as no details about the second dose was provided. Causality assessment for the event was not provided by the reporter. The benefit-risk relationship of mRNA-1273is not affected by this report. However, the event is of infective origin and thus assessment with product used is determined as unlikely based on biological implausibility.  The benefit-risk relationship of mRNA-1273is not affected by this report.   This case was linked to MOD-2021-325388 (Patient Link).; Sender's Comments: This case concerns a 59-year-old male patient with no reported medical history who experienced the unexpected events of Infection MRSA and kidney infection. The events occurred on an unspecified date after the first dose of mRNA. The rechallenge was unknown as no details about the second dose was provided. Causality assessment for the event was not provided by the reporter. The benefit-risk relationship of mRNA-1273is not affected by this report. However, the event is of infective origin and thus assessment with product used is determined as unlikely based on biological implausibility.  The benefit-risk relationship of mRNA-1273is not affected by this report.
pfizer covid vaccines given 2/4/21, 2/25/21, and 8/31/21 she is 60 now and began menstruating monthly since  about May of 2021, pending ablation w/ gyn
Patient received Johnson & Johnson COVID vaccine on 04/02/2021. Developed COVID symptoms; tested positive for COVID on 05/17/2021
mom reports h/a, rash & pruritis beginning Tuesday PM (no fever), became worse Wednesday;went to ER was given a shot of Adrenaline & rx for seldane & elastic bandage for lt arm;pt was out of school thursday but back to school Friday 15MAR;
Patient received expired immunization and opted for reimmunization at another pharmacy (Patient in good health when he returned for refund 12/14/14).
I95.9 HYPOTENSION 5/10/2022 PROSTATE CANCER I95.9 HYPOTENSION 5/10/2022 HOSPICE CARE I95.9 HYPOTENSION 5/10/2022 HX OF SUBARACHNOID HEMORRHAGE
Sinus rhythm with supraventricular ectopy; Sinus rhythm with supraventricular ectopy; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Mar2021 at 10:00 (at the age of 62-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Apr2021 at 11:00 (at the age of 62-year-old)as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 01Apr2021 at 23:00, the patient underwent electrocardiogram (EKG) with sinus rhythm and supraventricular ectopy which were always normal. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events sinus rhythm with supraventricular ectopy were unknown at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
My glands near my left clavicle became swollen; This is a spontaneous report received from a non-contactable reporter (Consumer). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14May2021 10:00 (Batch/Lot number: unknown) at the age of 35 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 16May2021, outcome "recovered" (May2021), described as "My glands near my left clavicle became swollen". Therapeutic measures were not taken as a result of lymphadenopathy. Additional information: 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.No Known allergies. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.