chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have never had ringing in my ears and when I had this, Its like a bad case of tinnitus; I can't hear; I hear like music very strange; now it's getting worse. In the afternoon I hear a motor, a constant noise in my ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Feb2021 (Lot number: EN5318) as dose 1, single and administered in arm left, administration date 25Feb2021 (Lot number: EN6203) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: Patient history: Blood pressure; "Stenosis" (unspecified if ongoing); "back condition" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "Pain" (unspecified if ongoing); "antidepressant" (unspecified if ongoing). Concomitant medication(s) included: OXYCODONE taken for back disorder; ENALAPRIL taken for blood pressure abnormal; VENLAFAXINE taken for blood cholesterol; HYDROCODONE taken for pain; BUPROPION taken for antidepressant therapy. The following information was reported: TINNITUS (non-serious), outcome "not recovered", described as "I have never had ringing in my ears and when I had this, Its like a bad case of tinnitus"; HYPOACUSIS (non-serious), outcome "unknown", described as "I cant hear"; HYPERACUSIS (non-serious), outcome "unknown", described as "I hear like music very strange"; CONDITION AGGRAVATED (non-serious), outcome "not recovered", described as "now its getting worse. In the afternoon I hear a motor, a constant noise in my ear". Therapeutic measures were not taken as a result of tinnitus, hypoacusis, hyperacusis, condition aggravated.  Additional information:  Consumers have a back condition. So, patient took medicine for my back and patient had a blood pressure medicine but other than that healthy, active, walk every day, no problems, no heart condition, no cancer in family. patient very healthy.For my back a pain, one medication was called Oxycodone, patient took Oxycodone 10mg. daily for back, patient had stenosis unfortunately but any case, blood pressure medicine was, well this, its Enalapril 10mg and then lets see, this was another one guess this was for my, Venlafaxine, patient think thats for Cholesterol (Further clarification unknown) so, this was the other one, this one says 150mg. and patient also, this was another pain medication this one patient think was called Hydrocodone for her back, this one was 10-325mg. Yes, patient have a condition called Stenosis. There was another one for an antidepressant and this one called Bupropion and this one was 300mg, once a day." Prior Vaccination (4 Weeks): no vaccinations. Vaccination facility type: Consumer stated, "It was like a big gymnasium. Time of vaccination: afternoon like from 12 to 2 something like that."   No follow-up attempts are possible. No further information is expected.
no additional adverse event reported; one dose of improperly stored VARIVAX was administered to the patient; This spontaneous report as received from an office manager refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.  On 11-MAR-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot# S025608, expiration date: 18-AUG-2021 (strength and route of administration were not provided) for prophylaxis. The sterile diluent used to reconstitute the vaccine was stored properly.  The varicella virus vaccine live (oka/merck)(VARIVAX) was stored in a temperature -8.3 Celsius degrees for 24 minutes as recorded by digital data logger. No previous excursion was noted. No additional adverse event reported.
sore throat; cough; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 28-year-old male patient received BNT162b2 (BNT162B2), on 15Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 28 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number: 2, single, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization; Covid-19 vaccine (Dose Number: 1, single, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization. The following information was reported: COUGH (non-serious) with onset 18May2022, outcome "unknown"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of cough.  Additional information: It was unknown if patient had covid prior vaccination. Patient had covid test post vaccination.   No follow-up attempts are possible. No further information is expected.
No adverse event; patient was vaccinated after the expiration date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was vaccinated after the expiration date) and NO ADVERSE EVENT (No adverse event) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066K21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 26-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was vaccinated after the expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient was vaccinated after the expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (patient was vaccinated after the expiration date).    At the time of an unannounced visit by a Moderna representative on 28-Sep-2022, 50 doses of Moderna vaccines were left in the health department which were looked well after but they were uncompliant since that lot of Moderna vaccines had expired on 07-Jul-2022.  Additionally it was mentioned that the expiration code on the packaging slip was not the expiration code, instead they had to scan the QR code to determine the actual expiration code, which they failed, by not reading carefully the packing slip.  The patient had received the expired vaccine on 26-Aug-2022.  Concomitant medications details were not reported by the reporter. Treatment details were not reported by the reporter.
8 PM; severe shaking and shivering, low fever 100F; mild aching; continued through the night. Shivering controlled by a heating pad. Next 24 hours general fatigue.
circumstance or information capable of leading to medication error; had a bad tooth; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021335707 (Pfizer).  A female patient received bnt162b2 (BNT162B2), administration date 24Mar2021 (Batch/Lot number: unknown) as 2nd dose, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for Covid-19 immunisation.  The following information was reported: CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), outcome "unknown", described as "she received her second dose of the Pfizer BioNTech COVID-19 vaccine today and may possibly be started on antibiotics soon for a dental procedure. She would like to know if this will affect the vaccine."; DENTAL DISCOMFORT (non-serious), outcome "unknown", described as "had a bad tooth".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Presents with AKI (Cr 8), lactatic acidosis 18, hypotension to hospital. No clear source found. TTE and troponins pending.
Vaginal bleeding after both first and second shot. I have never had off cycle bleeding in my entire life and I am 43. The bleeding is not a small amount of blood and alarming.
This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266) via an unspecified route of administration in the left arm on 24Feb2021 at 07:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroid and obesity. It was reported "none known" allergies to medications, food, or other products. 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. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9262) via an unspecified route of administration in the left arm on 27Jan2021 at 07:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. On 25Feb2021 at 19:30 (also reported as 18:30), 36 hours later the vaccination, the patient had pain in her armpit, maybe lymph nodes "?" 64 hours later it moved down arm pretty severe pain "in ? fat ?" of arm under the armpit and pain to touch and pain to lifting the arm and maybe called stinging pain. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain in her armpit, maybe lymph nodes 64 hours later it moved down arm pretty severe pain in arm under the armpit and pain to touch and pain to lifting the arm and maybe called stinging pain was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
PATIENT HAD FIRST COVID SHOT OF MODERNA VACCINE, GOT SECOND COVID SHOT OF PFIZER
pt recv vax 20MAY98 @ PM mom noticed whelps on cheeks, 22MAY98 red area moving around neck toward back of ears, no pain, no fever, no itching;
shingles on buttocks with multiple cold sores around her mouth; shingles on buttocks with multiple cold sores around her mouth; This spontaneous case was reported by a nurse and describes the occurrence of HERPES ZOSTER (shingles on buttocks with multiple cold sores around her mouth) and ORAL HERPES (shingles on buttocks with multiple cold sores around her mouth) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 010M20A) for COVID-19 vaccination.     The patient's past medical history included Shingles (Stress causes shingles reported.). Previously administered products included for Product used for unknown indication: Tetanus toxoid. Concurrent medical conditions included Drug allergy (ASA), Drug allergy (Vioxx) and Allergy to antibiotic (Augmentin).   On 29-Jan-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021 at 3:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HERPES ZOSTER (shingles on buttocks with multiple cold sores around her mouth). On 08-Mar-2021, the patient experienced ORAL HERPES (shingles on buttocks with multiple cold sores around her mouth). The patient was treated with ACYCLOVIR [ACICLOVIR] for Antiviral treatment, at an unspecified dose and frequency. On 08-Mar-2021, HERPES ZOSTER (shingles on buttocks with multiple cold sores around her mouth) had resolved. At the time of the report, ORAL HERPES (shingles on buttocks with multiple cold sores around her mouth) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to MOD-2021-208855 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Patient demographics, Relevant medical history, Dose 2 details, Event Onset date were updated.
I began having extreme shooting pain in my joints and chest to the point where I was concerned I was having a cardiac event.  I could not climb my stairs without my blood pressure dropping requiring me to sit before I could even reach the top.  I am in very good shape.  This is my second shot and while I had similar symptoms last month, it was more profound with the second vaccine. I have been coughing ever since I got the first shot, which I was not doing prior to the shot.  The coughing is so exacerbated now that I cannot even finish a simple sentence without coughing.
On the evening on 07/08/2022 I had a little bit of a sore throat and my voice dropped a bit. On the next day, I noticed some sneezing and a runny nose. Later in the day, I developed a significant headache which is unusual for me. I took 2 aspirin that night which got rid of the headache. I continued with common cold like symptoms and my husband seemed to be coming down with the same thing. At the suggestion of a friend, we tested for COVID-19 on 07/11/2022 with a PCR test and the results were positive the next day. I called my doctor after receiving the results and he prescribed PAXLOVID. After beginning the PAXLOVID, my symptoms continued to improve although I feel that they were progressing well on their own.
went to urgent care c/o bilateral arm "muscle twitching and neck. Urgent care transferred her to ER.  ARNP reports 17 YOF who comes to ER after 4 hours of receiving her second vaccine shot  for covid-19 , presenting upper extremity fasciculation.  TOE: 1800 TOA; 2200 To PE bilateral fasciculation in arms and neck. NO SOB , no difficulty  to swallow or talk.  |BP=122/74, HR=120.0 bpm, Temp=96.62 F Oral, Resp Rate=20.0 bpm, Pulse Ox=99.0 on Room Air  Patient discharged at 0325
2.5 x 1.5 inches area of induration R upper arm SQ, redness, warm and painful to touch.
Baseball sized redness, swelling and tenderness at injection site.  Some tenderness and redness the night of injection.
Pt has Latex allergy, and was given the Moderna Booster. She had a reaction to the band aid used, which was latex free. Pt still has some itching 3 days later, nothing has been applied to the allergy site.
She is having hard time walking/can hardly walk; Swelling/swelling at the arm of injection site one and a half days; Different things; Issues with right leg; Joint pain/has pain from top of the right leg to right knee; Bruised; Nausea; Tiredness; Arm pain as well; This is a spontaneous report from a contactable consumer (patient). A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was EW0198), via intramuscular in left arm on 28JUN2021 at 10:30 (at the age of 66-years-old) as first dose, single for COVID-19 immunization. The patient also received Paracetamol (TYLENOL 8 HOUR) and Naproxen sodium (ALEVE) both on an unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included history of arthritis and Apr2020 (last year) she had surgery to remove a sarcoma from right hip/buttock and was unsure if that had anything to do with her right leg in the condition that she reported below post vaccination. The patient concomitant medication was not reported. On an unspecified date in 2021, patient experienced joint pain, swelling and "different things" and issues with right leg as she was having hard time walking. The minute she received the injection she experienced swelling and it lasted for 1.5 days, it was bruised, and she iced it per vaccine provider recommendations. Places where she is arthritic, she had experienced swelling. She also experienced nausea and tiredness post vaccination. On 28Jun2021 at 10:30, she had swelling arm/Injection site swelling one and a half days. On 29Jun2021, she could hardly walk on right leg. She reported that there was pain/aching in right leg from the top of leg to the knee. Patient also reported that her vaccine provider (Pharmacist) experienced bad arm pain as well. The girl that vaccinated patient called her to check in to see if swelling had gone down. Vaccine provider told patient that she personally took Tylenol. Vaccine provider said that studies have not been 100% sure if Aleve lessens the effects. She could probably take Tylenol if had to but that did not help her there, the only thing that really helped her was Aleve so, she was wondering if she could take an Aleve or not. The patient was not taking any treatment drug. The outcome of event (leg pain) was not recovered, swelling at vaccination site was recovered on 29Jun2021 at 22:30 and rest of all events were unknown.
This spontaneous report was received from a lawyer referring to a 68 years old male patient. Information about medical history, concurrent conditions and concomitant therapies was not provided. On 02-DEC-2016 and 17-OCT-2018, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (strength, dose, route, lot # and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration).        The case was split from a legal case referring the same patient.; Sender's Comments: US-009507513-2108USA005243:
So the first thing I noticed was pain in my upper shoulder up to the left side of my neck, then I noticed swelling in my hands and then the whole left side of my body from my neck down to my hands and arm, I had itching in my ears and other places but no hives, my whole left side of my body was numb, went to the ER around 5pm and they just checked to make sure I did not have a blood clot any where, they ordered an ultra sound and a CT scan and it was founded with no clots, and I was just sent home and was advised that it would go away on it's own.  I also had a hard time moving my left hand as well on Friday.  Only has a small amount of swelling left today.
After receiving the vaccine 2/26 around 3/1/2021 I had a reaction,  my fingers and wrist was hurting, after 2nd dose on 3/19  the pain got really bad and progressively worse with inflammation and it was unbearable pain. Some days I'm unable to move and cannot live a normal life at all, sometimes I cannot brush my hair or teeth because I'm in so much pain. I'm on leave because of the reaction, I saw my PCP, the rheumatologist and orthopedic doctor.
Hives and redness on chest and down right arm, 25 minutes after vaccine administered. 50 mg Liquid Benadryl given. Symptoms resolved in 6 minutes.
This spontaneous report as received from a healthcare student refers to a patient of unknown age. The reporter reported that the patient received the first dose of GARDASIL more than one year ago and received the second dose today. No adverse effect reported. Additional information has been requested.
chills, muscle aches, tired.  began at 2 PM Monday, the day of vaccine; continued thru the night; difficult sleeping; symptoms continued until about 3 PM the next day.  Chills and aches subsided.  slept much better Tuesday night.  Symptoms gone by Wednesday AM.
Patient's father came into pharmacy and wanted 13yo daughter vaccinated today because she was leaving for out of country on 12/16/21 and wasn't returning for 4 weeks. Pt was here to get 2nd dose covid pfizer. Today marks 18 days between doses (1st dose 11/26/21).
Patient noticed continued soreness after the SHINGRIX vaccination was administered and has continue since 11-13-18. He was seen by Dr. and was told to use OTC TYLENOL and heat to treat. It help some but he has continued to have soreness since that date.
Severe headache, aches, chills, nausea, dizziness, sudden onset.
Disorientated; Falls; Could not eat or drink; Dizziness; Hot shoulder; All the body was achy; Tender shoulder; Red shoulder; A spontaneous report was received from a 76-years-old female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events Disorientated (Disorientation), Falls (Fall), Could not eat or drink (Decreased appetite), Dizziness (Dizziness), All the body was achy (Myalgia), Tender shoulder (Vaccination site pain), Hot shoulder (Vaccination site warmth) and Red shoulder (Vaccination site erythema).  The patient's medical history included procedure for cataract surgerydone on an unknown date. No relevant concomitant medications were reported.  On 25-FEB-2021, prior to the onset of the events, the consumer received second of two planned doses of mRNA-1273 (batch number: 030L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 02-MAR-2021, the consumer experienced the events Disorientated, Falls, Could not eat or drink, Dizziness, All the body was achy, Tender shoulder, Hot shoulder and Red shoulder.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of events, Disorientated, Falls, Could not eat or drink, Dizziness, All the body was achy, Tender shoulder, Hot shoulder and Red shoulder  was unknown.; Reporter's Comments: This case concerns a 76 Y/O F with serious unexpected events of disorientation, fall, decreased appetite and nonserious unexpected dizziness, feeling hot and erythema and expected arthralgia, myalgia.  Event onset 6 days after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Initially began with muscle aches progressed in to chest pain then developed shortness of breath and cough.  diagnosed with myopericarditis treated with colchicine, CHF EF preserved has restrictive pattern on TTE due to inflammation, Mitral regurgitation (mod-severe on TTE). Discharge medications: acetaminophen 325mg 2 tablets every 4 hours as needed, colchicine 0.6mg 2 times a day, furosemide 20mg daily, amlodipine 10mg daily, spironolactone hydrochlorothiazide 25/25 daily, losartan 100mg daily, please see entire medical record for complete details