chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Ringing in ears; Stuffed up feeling in ears; This spontaneous case was reported by a nurse and describes the occurrence of TINNITUS (Ringing in ears) and EAR DISCOMFORT (Stuffed up feeling in ears) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 012M20A) for COVID-19 vaccination.     Concomitant products included BOTULINUM TOXIN TYPE A (BOTOX) for Migraine, BISOPROLOL FUMARATE (ZEBETA), HCTZ, KCL, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), AMLODIPINE BESILATE (NORVASC), LISINOPRIL DIHYDRATE (PRINIVIL), TRAVOPROST (TRAVATAN), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), VITAMIN D [VITAMIN D NOS], VITAMIN C [ASCORBIC ACID], PROBIOTICS NOS, CALCIUM and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced TINNITUS (Ringing in ears) and EAR DISCOMFORT (Stuffed up feeling in ears). At the time of the report, TINNITUS (Ringing in ears) and EAR DISCOMFORT (Stuffed up feeling in ears) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No medical history was reported by the reporter. No treatment information was provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was Not applicable.
Months later after receiving the vaccine, my left arm and leg were numb with little to no motion or movement permitted. I called 911 and was taken to a local medical center on 11/03/2021. They ran numerous tests, but the one that confirmed my stroke diagnosis was the MRI. They prescribed me with Plavix (blood thinner) and increased my dosage of atorvastatin to help treat my stroke for everyday living. Currently, the numbness is gone in my arm, but I still have some numbness in my leg that causes me to limp a little when walking.
Pt was given inproper vaccination at site insted of one injection three were given in the form of a triangel.  Pt has had major lymphadnopathy with inflammation and streaking from sight to lymphnode in left axillary.  Pt given IV Ancef with Toradol and 2000 ml.
The wrong vaccine was grabbed from the refrigerator. The error was discovered while charting lot numbers on computer.
Approximately 1 min. after receiving the Yellow Fever vaccine, which was the last of 6 vaccines given (Hep A, Flu, MENVEO, Rabies, Tdap.  )Pt started to become pale and stated he felt lightheaded.  Lowered pt. to supine, applied cool pack to the back of his neck.  He never lost consciousness.  He was able to speak coherently.  Remained supine for 10 min. then sat in a chair for 10 min.  His color returned to normal after about 3 min. in the supine position.  He drank 8 oz. of water during the 10 min. he sat in a chair.  He stated he felt fine and left the office.
3/24/21 - malaise, fatigue, headache 3/26/21 - pt complained of being "freezing cold" 4/2/21 - Arms and legs cyanotic for 15 minutes 4/3/21 - sustained pulse of 160+ for 7 minutes while laying in bed  Second immunization 4/12/21 3 days of malaise, fatigue, dyspnea moderate pain in sternum/chest for approx 10 minutes 4/15/21 - dyspnea; pt described felt like "climbing stairs 100 times"
pt recv vax 27SEP96 & 28JAn97 pt devel shingles consisting of 10 groups of lesions from the fingers to the shoulder on the pt rt arm;
Arm ache, chills, severe headache, fever, muscle aches for 2 days; then headaches and muscles aches 2 days after.
feeling like he´d been knocked over a bus; pain / as when he got the Shingrix / feeling like he´d been knocked over a bus; This case was reported by a consumer and described the occurrence of pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain and feeling abnormal. On an unknown date, the outcome of the pain was recovered/resolved and the outcome of the feeling abnormal was unknown.   It was unknown if the reporter considered the pain and feeling abnormal to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of shingrix and experienced feeling like he´d been knocked over a bus and pain. The information regarding consent to follow up was not reported. No further information was available
Red, hard slightly swollen,  itchy 1.5 inches around site.  Has been quite achy since day 1.
onset of sz activity approx 8hr p/vax;no prior sx or significant medical history;pt cont to have sz & work up as well as treatment is ongoing;
Patient passed out about 10 minutes after receiving 5 vaccinations at her 4 year old well check up.  While under observation, she passed out in her mother's arms.  These episodes could have been mini seizures.  She lost color in her skin and lips, became clammy to the touch and irritable.  Patient was able to leave the drs after 30 minutes.
Patient is a 12 yr/o child with a history of mobility, pots, factor VII deficiency, scoliosis who presents with chest pain and headache after receiving the second Covid vaccine.     Mom reports patient got the second Pfizer Covid vaccine yesterday.  After the vaccine the patient had some nausea and dizziness which he occasionally has at baseline.  This morning when the patient woke up he was having chest pain with deep breathing and complaining of burning in the chest.  Mom reports the patient had a temperature to 100.7 at home.  Mom endorses decreased activity level and mom noted the patient to have a heart rate to the 130s at home.  Patient endorses chills and nausea without vomiting, no diarrhea.  Patient also endorses a poor appetite today. the patient has difficulty describing the exact location of the chest pain, mom reports that the patient has always had difficulty with pinpointing the exact location of pain.
digestion problem; Sore pain at injection site (Right); nausea; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (digestion problem), VACCINATION SITE PAIN (Sore pain at injection site (Right)) and NAUSEA (nausea) in a 57-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     The patient's past medical history included Digestion impaired. Concomitant products included PANTOPRAZOLE for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced DYSPEPSIA (digestion problem), VACCINATION SITE PAIN (Sore pain at injection site (Right)) and NAUSEA (nausea). On 02-Mar-2021, VACCINATION SITE PAIN (Sore pain at injection site (Right)) outcome was unknown. At the time of the report, DYSPEPSIA (digestion problem) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
1.stiffness in joints, 2. achy 3. coughing 4.runny nose 5. feeling tired 6. nauseous 7. blurred vision
Right arm became weak, tingly and cold. Pt became sweaty, flushed and felt a warm sensation come over  body.  Became dizzy and lightheaded. Pt assisted to floor and then to stretcher by staff. Arrived to med obs with all symptoms resolved except right arm weakness and tingling. Right arm warm to touch. Bilateral hand grips equal. No arm drift noted. No reaction noted at vaccine site. Vitals remained stable during evaluation. Initial vitals as follows; BP 127/78 HR 57 RR 14 spo2 99%. Final vitals as follows; BP 126/80 HR 48 RR 14 spo2 99%. Pt instructed to follow up with physician if symptoms don't resolve within an hour or symptoms get worse. Pt left facility by self @ 1526.
child received an extra dose of pentacle with no reported adverse event; Initial information received on 27-Apr-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 1-year-old male patient who received an extra dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] with no reported adverse event.  The patient's past vaccination(s) included IPV on 21-Apr-2021, HIB VACCINE on 22-Nov-2021, DTAP VACCINE on 22-Nov-2021. The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE) for Prophylactic vaccination.  On 26-Apr-2022, the patient received 0.5ml total dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (strength, formulation: unknown) (lot: UJ622AA and Expiration Date: 07-Dec-2022) via intramuscular route in the left thigh for Immunization.  On 26-Apr-2022 the patient developed a non-serious event; child received an extra dose of pentacle with no reported adverse event (extra dose administered) same day following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Reportedly, Additional Description of event Adverse events: HCP states a patient was given a 5th dose of Pentacel.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the event (child received an extra dose of pentacle with no reported adverse event).  At time of reporting, the outcome was Unknown for the event child received an extra dose of pentacle with no reported 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 the 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.
1/7/2021  Woke up at about 6am with sore arm, muscle/joint pain, low grade fever 100.4. treated with ibuprofren and tylenol 1/8/2021  Took more ibuprofren at 4am, 'feel just fine'. *I think that severity of the symptoms, which i was expecting, the 2nd dose was more 'hard hitting' then the first; More side affects with muscle and joint pain.
Presents to ED due to altered mental status,positive COVID test in the ED, Admitted with severe spesis, COVID-19 pneumonia with possible superimposed bacterial pneumonia. Dexamethasone, remdesivir, antibiotics,D/C to skilled nursing facility.
One minute after the vaccine, became nauseated.  About 15 minutes afterwards, left arm started to itch.  Nausea became worse too.  EMS called to evaluate patient.  Patient taken to ambulance and staff established an IV and gave Diphenhydramine 50 mg IV and ondansetron 4 mg IVP.  Patient then transported to hospital.
When mom woke up she noticed a rash all around the injection site. They were little red bumps (not oozing or bleeding).
Information has been received from a pharmacist concerning a female who in approximately 2009, about 1 year ago, was vaccinated with a dose of ZOSTAVAX (Merck). The patient complained of getting shingles a few days after the ZOSTAVAX (Merck). Additional information has been requested.
THIS PATIENT DEVELOPED BELL'S PALSY 7 DAYS AFTER THE INJECTION
PAIN IN RIGHT UPPER ARM, NUMBNESS AND TINGLING IN 4TH AND 5TH FINGERS OF RIGHT ARM. CONTINOUS PAIN AND LIMITED RANGE OF MOTION IN RIGHT ARM. TAKING IBUPROFEN FOR PAIN.
Starting approximately a week after the vaccine was administered,  cranial pressure / burning sensation started particularly in the forehead area.  This has been accompanied by headaches / pain experienced in the forehead areas and sometimes spreading to other areas of the head.  This has been constant now for over 11 weeks with varying degrees of intensity.  Nothing else changed (diet / lifestyle  / etc.) that seems to be able to account for these symptoms, never experienced before that appeared all of a sudden, other than the administration of the vaccine.
Pfizer BioNTech Covid 19 vaccine EUA-  Symptoms started at 2100 on 1/5/21 and ended 0800 01/07/2021-- fever 101.3, body aches, chills, extreme fatigue, sore throat, dizziness, sinus congestion , abdominal pain, tender lymph nodes in neck HA and pain at injection site.
Patient was given Moderna vaccine on 4/1/21 at the age of 16. At this time, Moderna is not approved for use in patients under the age of 18.
Pt reports 24 hrs post vaccine developed severe headache and aching all over, next day pain all over her body temp 100F, next day feeling weak, loss of appetite.
Pain, swelling at site of injection from upper right arm to almost bend of arm. Red raised are approx. 1" over same area, lasted 3 days.
Cough  Fatigue  Headache  New loss of taste or smell  Congestion or running nose
Had the shot on October 1, 2019.  I woke up on Monday, October 7, 2019 with a rash and swelling in my face.  I went to the doctor that night and saw Dr.  Dr. observed the swelling and rash on my face.  He did not know what it was but he told me to take Benadryl.  On October 22, 2019 I saw Dr., my PCP, about the dark spots that had started to form on my face.  She did not know what it was and she told me to make an appointment with a dermatologist.  I made and appointment with Dr. of Dermatology.  My appointment was on October 28, 2019.  Dr. did not know what the issue was but he made a potential diagnosis of Lichen Planus vs sarcoidosis vs lupus vs connected tissue disorder. Dr did a biopsy on my face to find out definitely what the diagnosis should be.
Chief Complaint This patient is a pleasant 59-year-old man with no significant past medical history and has been adequately immunized with a Johnson & Johnson Covid vaccine March 2021 has been admitted for multifocal pneumonia and acute hypoxic respiratory failure due to COVID-19.  Duration of symptom is almost 2 weeks and has 2 other family members sick with Covid 19  History of Present Illness This patient is a pleasant 59-year-old man who works as a painter.  He stated that he has been having unhygienic workplace and may have caught infection somewhere at workplace.  He became acutely aware and symptomatic with cough fever body aches nausea loss of appetite and diarrhea about 2 weeks ago.  He has been living and household consist of his daughter wife who is been sick with similar cough and congestive symptoms but improved not needing any hospitalization. Patient himself has been awake alert oriented x4 sitting upright using supplemental oxygen by nasal cannula and does not show any signs of distress or toxicity/resting comfortably.  Earlier had some back pain and intractable cough low appetite into loose stool. He has been brought in and does not qualify for remdesivir, steroid therapy has been initiated supplemental oxygen as well as antitussive therapy advised and infectious disease service requested to see the patient.
This is a spontaneous report received from a contactable consumer (patient). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via unspecified route of administration in left arm on 30Mar2021 03:00 PM (at the age of 52-year-old) as 1st dose, single dose for COVID-19 immunisation. The patient's medical history included hepatitis, hemochromatosis, high blood pressure, known allergy to nickel. No COVID prior vaccination was reported. The patient's concomitant medications included losartan, from unspecified date at 50 mg, daily. No other vaccine was received four weeks. The patient previously took ciprofloxacin (CIPRO) and she experienced allergy. Patient reported that he received the Pfizer vaccine and he was involved in a vaccine clinic where they made some mistakes. He might or might not have received the first vaccine. They were not sure. They did not think he did. They scheduled me for 3 weeks in case he did get the vaccine. They think he might have gotten just saline solution instead of the vaccine. He knew Pfizer was doing testing on receiving a third dose instead of just two doses. Patient asked information on receiving a third dose. It was also reported that on 31Mar2021 12:00 PM the patient was suffering from weird smells that were not actually there, kind of bitter and sulfur like. It was very strong. Please note, he never actually had COVID. No treatment was received due to the event "smell alteration". The patient was not tested for COVID post vaccination. The outcome of the events was not resolved for "smell alteration" and unknown for the other event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 07-MAY-2016, the patient was vaccinated with an expired dose of GARDASIL (lot # J006850 and expiration date 31-MAR-2016, dose and route of administration was not reported). Concomitant therapy was not reported. No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
tested positive with COVID 19; tested positive with COVID 19; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21-year-old male patient received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive with COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Consumer tested positive with COVID 19. Therapeutic measures were taken as a result of drug ineffective, covid-19.Consumer prescribed Paxlovid and is responding well to therapy. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Two days after vaccine received 45x60mm red, tender area noted to (R) upper posterior arm. Area itchy at thighs. No systemic symptoms noted.
He was injected and within 4 minutes he started jerking and loss conscious two times at 10 seconds each and involuntary jerking and turned white as a ghost
Patient received DTaP right deltoid 5/21/07 in afternoon of 5/22/07 - Mother (legal guardian) called clinic to report swelling, redness, itching over right deltoid. Told to come in, came in AM 5/23/07 - afebrile, fullness right arm; full strength, pulse intact deltoid edematous, erythematous, no erythema or d/c from injection site erythema extend  of the way to elbow.
Pt developed fever the evening immunizations were given. Fever lasted 4 days. Highest temp was 104. Also developed hives 2 days after immunizations. Child was taking antibiotics, Suprox, 100mg daily. Mom took baby to her doctor 2 days later. Mom stopped antibiotic on her own when hives developed. Child diagnosed with left ear infection. Now has a faint, flat rash from hives on abdomen and legs.
heartbeat in his head; headaches ever since his first dose/throbbing; Only received one dose, Patient did not receive his second dose.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Only received one dose, Patient did not receive his second dose.), HEAD DISCOMFORT (heartbeat in his head) and HEADACHE (headaches ever since his first dose/throbbing) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Only received one dose, Patient did not receive his second dose.). On an unknown date, the patient experienced HEAD DISCOMFORT (heartbeat in his head) and HEADACHE (headaches ever since his first dose/throbbing). On 09-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Only received one dose, Patient did not receive his second dose.) had resolved. At the time of the report, HEAD DISCOMFORT (heartbeat in his head) and HEADACHE (headaches ever since his first dose/throbbing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported  The patient received steroid drug as a treatment medication.  It was reported that ever since the patient received his first dose of vaccine he constantly getting headaches, like throbbing headaches, which got worsed when he was outside, It was painful.
I report this adverse event due to potential safety and quality of Pfizer vaccine for beyond use date. Pharmacist at Pharmacy. I want to check with you for the quality and safety of the remaining Pfizer Vaccine we have left in stock (648 doses equals 108 vials). I received a shipment of Covid-19 Pfizer Vaccine product on April 20th, 2021 for 1176 doses. I transferred the shipment to a low freezer fridge at a temperature range from -13 celsius to -24 celsius. Per ACIP guidelines, Pfizer is good to use for 14 days after removing from ultra cold storage and additional 3 excursion days. Based on the guidelines, Pfizer doses are good to use until May 6th, 2021 (15 days from April 20th, 2021). However, 333 doses of Pfizer vaccine was continuously administered to patients until May 28th, 2021 beyond use expiration date on old recommendation (May 6th to May 28th, 2021). Can you advise me on the quality and safety of use in this scenario if there is any data to support this or not? What to do with those patients who received vaccines during this excursion period?  Of note, FDA has authorized Pfizer vaccine to be kept up to 30 days at 2C to 8C on May 20th, 2021. Is there any extension beyond use date  for this vaccine in this case?
Chest pain, vomiting, and elelvated troponin 15 days after vaccine
Left arm swollen, "feels hard" warm to touch redness noted deltoid to midway of elbow. pt does use arm complaint of pain. The follow up received on 4/7/03 states child wsa hospitalized after receiving 4 year old shots DTaP, EIPV, and MMR  d/T severe local reactions. Pt's father does not feel he should be held responsible for payment of hospital bill and is requesting compensation.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On 29-SEP-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, route, indication not reported). Concomitant therapy included valacyclovir hydrochloride. On an unknown date in 2013 ("subsequently") the patient developed a large red mark at the injection site. The patient sought medical attention via called the pharmacist. The outcome of the event was reported as not recovered. The pharmacist also noted she had seen other red marks at a ZOSTAVAX injection site, just not as large. Additional information has been requested.
Headache, 7:00 PM felt cold to the touch, 8:00 PM Nausea, 6:00 AM on 1/17/2013 more nauseous than previous day.