chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the ringing in my left ear has gotten worse and louder; the ringing in my left ear has gotten worse and louder; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Dec2021 at 12:30 as dose 3 (booster), single (Lot number: FL3197) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyrodism" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; LEVOTHYROXINE; CALCIUM; BIOTIN. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EW0170, Location of injection: Arm Right, Vaccine Administration Time: 10:30), administration date: 24Apr2021, when the patient was 63-year-old, for covid-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: ER8737, Location of injection: Arm Right, Vaccine Administration Time: 14:15), administration date: 02Apr2021, when the patient was 63-year-old, for covid-19 immunization, reaction(s): "lost some hearing in the left ear", "ringing in my left ear/tinnitus". The following information was reported: TINNITUS (disability), CONDITION AGGRAVATED (disability) all with onset 2021, outcome "not recovered" and all described as "the ringing in my left ear has gotten worse and louder". The events "the ringing in my left ear has gotten worse and louder" required physician office visit. The patient underwent the following laboratory tests and procedures: Acoustic stimulation tests: (unspecified date) lost some hearing in the left ear, notes: He also performed an extensive hearing test and I have lost some hearing in the left ear; Ear, nose and throat examination: (05Oct2021) tinnitus, notes: I had an ENT confirm in an appt on 05Oct2021 that I have tinnitus. Therapeutic measures were not taken as a result of tinnitus, condition aggravated. Clinical course: The patient had not take any other vaccine in four weeks. The patient had not Covid prior vaccination and had not test Covid post vaccination. The patient had no known allergies.
Headache moderate joint and muscle pain all lasting approximately 16-18 hours which I treated with 800 mg  ibuprofen every 6 hours
Left arm from injection site to hands swelled. The arm felt warm and paint on touch to arm. This occurred the next morning at 10:00 am upon waking up. Patient put cold compress on arm.
ocedures:  PT was given Moderna (RED TOP) 0.5ML from 02/02/2023 instead of Moderna Bivalent 0.5ML Provider was informed along with PT. Per provider PT needs to F/U within a week to get booster vaccine, PT not at risk for any adverse reaction relating to dosage given. Pt was advised of possible usual side effects such as muscle soreness from Covid19 vaccines. PT informed of same and stated that she would return within a week to get Bivalent vaccine.  Patient Administered - Moderna Red Top COVID - 19 Vaccine LOT 074B22A. PT left without signs or symptoms of adverse reacton. PT stable upon departure.
Headache, Myalgia, Arthralgia, Fever, Inj site discomfort, chills, fatigue Narrative:
STROKE; 17 YEAR OLD MALE PATIENT GOT THE VACCINE; OFF LABEL USE; This spontaneous report received from a consumer via agency via a company representative concerned a 17 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, dose, start therapy date were not reported, administered for prophylactic vaccination which was an off label use as 17 year old male patient got the vaccine. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced stroke. The reporter reported that, "Strokes are way up among my extended acquaintance including a 17 year old boy. All vaccinated for covid". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stroke, 17 year old male patient got the vaccine and off label use was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220207981.; Sender's Comments: V0:20220207120-COVID-19 VACCINE AD26.COV2.S-Stroke. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
menstrual cycle started about 2-3 days early; This is a spontaneous report from a non-contactable consumer (patient). A 39-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: unknown) via an unspecified route of administration in the left arm on 09Apr2021 at 14:45 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. Patient had no relevant medical history (none). The patient had not reported any other health issues. The patient had no known allergies to medications, food or other products. The patient did not take any concomitant medications. The patient previously received first dose of BNT162B2 (Lot Number: unknown) via an unspecified route of administration on unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 09Apr2021 at 20:00, the patient had her menstrual cycle started about 2 to 3 days early. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported event. The clinical outcome of event (menstrual cycle started about 2-3 days early) was recovered on unknown date in Apr2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
her arm got swollen and had rash in her arm, report that the swelling was travelling along her arm. she went to ER on 07/04 was prescribed steroid pack
Patient presented to the ER on 11/5/21 via ambulance, his wife called b/c she thought he was acting confused and short of breath this morning.  On examination patient was A&O x4 but a poor historian about why he is in the hospital and the events leading up to today.  Patient does agree that he has been short of breath, denies any chest pain, palpitations, coughing, or nausea or vomiting. Pt was having dry cough during exam. In the ED patient was found to be COVID POSITIVE, SpO2 89%, requiring 2-3 L of oxygen via nasal cannula, afebrile, HR 74, RR 20, 114/59. ABG was wnl except pO2 58. WBC 16.59, CRP 207, procal 0.16, lactic acid negative, UA +3 esterase, BNP 78, CMP wnl. CXR Mild cardiomegaly as well as hyperinflated lungs as seen with COPD similar to prior, CT head Small-vessel ischemic and lacunar change. no hemorrhage.    Admitted for acute hypoxic respiratory failure likely secondary to covid.  Patient given Rocephin 1 g IV, Decadron 6 mg IV.  Ordered albuterol q6hr p.r.n., doxy 100 mg b.i.d., Remdesivir 200 mg IV once and 4 days of Remdesivir 100 mg IV. asymptomatic E. Coli UTI treated w/ rocephin. BNP 78, CMP wnl. Blood cultures 1/2 negative x2 days; 2/2 likely contaminant. CXR Mild cardiomegaly as well as hyperinflated lungs as seen with COPD similar to prior, CT head Small-vessel ischemic and lacunar change. no hemorrhage. CT of chest did not demonstrate covid pneumonia, but has several other findings that will require further workup outpatient (noted below). Patient remained afrebrile, and improved over course of admission; pt returned to baseline mentation. He received rocephin 1g IV q24hr x2, decadron 6mg IV qd x3, and Doxycycline 100mg bid x4 doses, Remdesivir 200mg IV once, and x2 days Remdesivir 100mg IV. Noted per pt's wife that pt had missed a couple of days of benzodiazepine; likely contributory to AMS. LFT's found to be elevated, w/ left hapatic lobe atrophy with intra hepatic biliary ductal dilatation - f/u LFTs and further workup outpatient. RT determined pt required room air at rest and during exertion. Pt to restart HHC, and d/c home w/ wife and sister in law; wife advised to ensure contact precautions with PPE use, and enabling patient to stay in isolation for an additional 7 days. Pt to f/u with PCP in 1 week; but will require telemedicine appointment due to COVID+ on 11/5/21.   Pt to continue following medications:   Decadron 6mg, daily x7 days; 10 days total (end 11/14/21).  doxycycline 100mg BID x3 days; 5 days total Abx (end 11/10/21) albuterol inhaler; 2 puffs q4hr prn.   Discharged on 11/7/21
Sucralfate 1gram   1tablet  4 times a  day,  Omeprazole  DR 40 mg  1 a day.  Muscle  cramps in several areas at the same time. Dizzy, burning  in my stomach and large intestines. nauseous, stool turned yellow for 7 days and burned my rectum, was very painful!!   Then  there  was blood in my stool. I  was  also weak. I'm  afraid to take second shot because  of the issues I had with the first shot!! I have never experienced anything  like that before. My stomach was so swollen I was afraid it would burst.I  was having  trouble breathing,  short of breath when I walked. Heart rate would would go to 111 beats  on Friday but  that  got better.
She walked out to the waiting room with her mother - was standing and started not to feel good. Told her mom she didn't feel good and collapsed hitting the back of her head on the floor. No LOC. Was immediately awake and interactive, noted to be slightly pale and sweaty. Taken to the treatment room - VS 113/83, hr 76, rr 16, o2 96% on room air. This set of vital signs were taken after drinking some gatoraide, lying back. Felt better and departed from the clinic on her own volition.
Discharge Provider: MD Primary Care Provider: MD Admission Date: 8/10/2022 Discharge Date: Aug 13, 2022  PRESENTING PROBLEM: Acute respiratory failure with hypoxia [J96.01] COVID-19 virus infection [U07.1]   HOSPITAL COURSE:   89-year-old male with past medical history significant for chronic diastolic heart failure, persistent atrial fibrillation, hypertension, type 2 diabetes, CKD who presented to the emergency department with progressive shortness of breath.  On arrival to emergency department patient is hypoxic requiring placement of 2 L nasal cannula for oxygen support.  His COVID test returned positive.  Chest x-ray showed left-sided basilar atelectasis.  Patient was started on Decadron and admitted to the medicine service for further assessment and management.   As far as acute hypoxic respiratory failure in setting of COVID pneumonia, patient improved with steroid treatment.  He was able to wean from 2 L to room air and remained comfortable.  He did receive 3 doses of his vaccine prior to admission.  Patient's symptoms related to COVID were resolved with the time of discharge, he will complete an additional 5 days of Decadron discharge.   As far as recently diagnosed renal hemorrhage/hemorrhagic cystitis from a CT urogram performed on 08/05, patient's hemoglobin was monitored in the hospital.  Eliquis was held.  Urology was consulted and recommended outpatient follow-up with them for eventual ureteroscopy to confirm mass followed by radical nephrectomy in the same setting.   Eliquis to remain on hold until this is performed.   Patient did have a mild AKI.  His home torsemide and losartan were stopped in the hospital.  Treated with IV fluids with improvement in his creatinine.  Recommended outpatient follow-up with primary care physician in 1-2 weeks to monitor BMP and creatinine.  Consider referral to Nephrology if not improving.   Patient discharged home in stable and improved condition.    We discussed he should call his urologist to determine when it would be safe to resume Eliquis again.  From medicine standpoint this could be done over the weekend.
Shaking, anxiety, hives by 1 hr after vaccine given. BENADRYL 50 mg was given IM per MD orders.
COVID vaccine breakthrough case.  Moderna 2/20/21 007M20A, 3/20/21 047A21A, and boosted 11/8/21 077C21B
Headache, Myalgia, Arthralgia, Fever, CoughWheeze, NauseaVomiting, HYPERtension, Tachycardia, , extreme weakness; O2 Sats los; fatigue; Chills Narrative:
"I seem to have broken out in hives after my vaccination yesterday.   Also it  hit hard and fast. Body felt miserable last night.  With dizzy spell."  ".....NURSING NOTE...... Patient noticed a rash on saturday after getting a covid vaccination. There are  red bumps to bilateral arms and legs. They appear to be in line formation.  Patient reports these bumps are itchy."  Patient also noted to have current incomplete root canal
sore throat began 3:30 worsened by 4:30, chest started tightening by 5PM-chest wouldn't expand to draw in enough air to breath by 5:15-much vomiting;called for help by 5:30 left for hosp about 5:30-2noc stay;
Information has been received from a female who on approximately 01-SEP-2007, was vaccinated with the first dose of Gardasil vaccine. On approximately 01-SEP-2007, the patient experienced a white square side effect at the injection site. As of 25-OCT-2007, the  patient had not recovered. No further information is available.
Headache, Fever, sore arm, headache, joint pain, muscle pain, fever chills, night sweats, sleeplessness, nasal congestion starting on day two, that persisted through 4-5 days. Still has headache on day 5 (today). Taking OTC tylenol as needed. Narrative:
Received the Pfizer COVID-19 Vaccine, first dose; Tested positive for Covid before getting the second dose; Received the Pfizer COVID-19 Vaccine, first dose; Tested positive for Covid before getting the second dose; This is a spontaneous report from a contactable consumer or other non hcp via pfizer sponsored program regulatory authority. A 12-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported), dose 1 via an unspecified route of administration on 30Jul2021 as DOSE 1, SINGLE for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received pfizer covid-19 vaccine, first dose; tested positive for covid before getting the second dose on an unspecified date in 2021. Patient was asking how long would it take for him to get the second dose. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date in 2021. The outcome of events was unknown.
Patient complained of cellulitis at site of injection was on antibiotic for 10 days & got better. Went to ER x 2 and doctor visit. She is fine now.
Status: Sign when Signing Visit Cosign Required: Yes    Patient had reaction to COVID-19 vaccine. Patient was monitored after COVID-19 vaccine as recommended per guidelines.    The following reaction signs/symptoms were observed: difficulty swallowing and other tounge itching  She had previus similar reaction to initial 1st dose did not for 2nd dose. Provider had advised to get booster. VS stable, no visual distress,no  SOB, lungs sound clear, denies n/v,dizziness.   Emergency response notified:  vitals taken and Dr  came and assessed. Symptoms improved.   EpiPen administered by RN as per standing order?:  No   Report given to Dr
mom states approx 5-10 mins p/inject pt started crying (high-pitched) & head dropped forward-lasted about 2-3 mins; This occurred again on 24FEB94 @ 7AM & again 25FEB94 @ 7AM; became limp w/difficulty breathing;
second dose of Rotateq was given to the patient on 05-APR-2022 and the third one on 24-JUN-2022 (timeframe: 10 weeks + 10 days); This spontaneous report was received from a nurse and refers to a 6-month-old female patient.  The patient's medical history and concurrent conditions were not reported. Concomitant medications included diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL) and pneumococcal vaccine conj 13v (crm197) (PREVNAR 13). Historical vaccines include: diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL) and pneumococcal vaccine conj 13v (crm197) (PREVNAR 13); and Hepatitis B Vaccine (Recombinant) (manufacturer unknown).   On 08-FEB-2022, the patient was vaccinated with dose 1 of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, then, on 05-APR-2022 and 24-JUN-2022 (Inappropriate schedule of vaccine administered) second and third doses were administered to the patient respectively administered orally for prophylaxis (strengths, lot #s, and expiry dates were not provided).  Other vaccines included: diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP); hepatitis a vaccine inact (manufacturer unknown); measles vaccine, mumps vaccine, rubella vaccine (manufacturer unknown); and varicella vaccine (manufacturer unknown).  This is one of 2 cases of the same patient.; Sender's Comments:  US-009507513-2306USA013096: US-009507513-2307USA009456:
Information has been received from a pharmacy student concerning an over 60 year old female consumer who "3 weeks ago" on approximately 15-AUG-2007, was vaccinated with a dose of Zostavax (Oka/Merck).  Subsequently, the patient developed unspecified hip pain.  Unspecified medical attention was sought.  At the time of this report the patient had not recovered.  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested.
Instant sterile taste and smell as I was being injected. End of nose had felt like slight burn.  Taste lasted a short time(about 3 hours).  Smell lingered for few days. I would describe the smell as to what a bandaid smells like when you open it.
A few minutes after receiving the vaccine, while I was in the 15 minute observation period, I began to feel hot and cold at the same time, began sweating heavily, my limbs started becoming very weak and I started seeing spots. I called over a doctor and explained what was happening. He got a wheelchair and brought me to a room to lie down. During this time, my vision continued to get worse (seeing more spots and less peripheral vision).  Upon laying down, the doctor put my feet up and a nurse took my blood pressure. If I remember correctly, it was 90/58. My normal blood pressure is around 112/68. A nurse also put ice under my neck. Immediately upon laying down, I started feeling better. I was observed for a while more and then a nurse took my blood pressure again (both laying down and sitting up). My limbs still felt weak when seated and my blood pressure was better but not normal yet, so I was told to lay down a bit longer. Then, a nurse checked my blood pressure again (laying down, sitting up and standing up). It was back to normal and I was feeling better. I was cleared to leave the vaccine clinic. Since leaving the clinic, I haven't had any abnormal side effects or reactions.
Severe headache, extreme cycling between high fever and shivering chills - lasting for about 14 hours. Continued lethargy.
Dose 1 administered on 23JUN2021, and dose 2 was administered on 12AUG2022, which is greater than 35 days; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 23JUN2021, and dose 2 was administered on 12AUG2022, which is greater than 35 days) and NO ADVERSE EVENT (No adverse event) in a 66-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 056M21A and 047B21A) for COVID-19 prophylaxis.     Previously administered products included for an unreported indication: Moderna COVID-19 Vaccine on 23-Jun-2021.   On 23-Jun-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Aug-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 23JUN2021, and dose 2 was administered on 12AUG2022, which is greater than 35 days) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 23JUN2021, and dose 2 was administered on 12AUG2022, which is greater than 35 days) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 23JUN2021, and dose 2 was administered on 12AUG2022, which is greater than 35 days).    No concomitant medications were reported. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-708314 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-708314:Bivalent dose case
non-interactive and withdrawn/not paying attention in class.  Head, shoulder/arm and eye "ticks" lasting 2-15 seconds per episode.
Day after vaccine, large red area bigger than 50 cent piece, painful. Next day, 24 hrs later was swollen to knee, hot to touch and cried continually. Lasted about one week.
NO ADVERSE EVENT to report. Administration error. Patient requested a "booster" of Moderna online through the app and then verified upon review on information with patient. He did not have his vaccination records with him. A booster dose of 0.25ml was given in right deltoid. After injection during the waiting period he said that he had only received 1 previous covid vaccination (moderna) which was found to be March 2021. Verified through local registry. The patient was then given a second 0.25ml dose in the opposite arm (left deltoid) to complete the 0.5ml dose needed for his second vaccination. So technically an administration error for 2nd dose, but it was corrected immediately with the patient. No adverse events to report.
Patient was administered Booster dose of Pfizer vaccine. He moved out to the waiting area and during his period of observation, suddenly became very pale, began coming in and out of consciousness, started sweating heavily, and reported tingling in his hands and feet. Patient reported no issue with either of the first 2 doses of the vaccine. Pharmacy contacted EMS and monitored patient until arrival. EMS assessed and continued monitoring patient until he was able to stand up and walk out on his own. Pharmacy contacted patient the following day. He reported EMS had suspected some kind of anxiety attack and had not administered any medication. Patient stated he had not sought out any further medical care and was no longer experiencing any symptoms except for a sore arm.