chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AEs; RECOMBIVAX HB 0.5ml was administered to a 22 year old patient instead of 1ml.; Information has been received from a medical assistant reporting on a 22-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On 16-NOV-2020, the patient was vaccinated for the first time with hepatitis B vaccine (recombinant) (RECOMBIVAX HB) lot# reported as 4G2TT, expiration date 20-FEB-2021 for prophylaxis, with a dose of 0.5 mL instead of 1 mL. No additional adverse events reported.  Lot number 4G2TT is an invalid lot number for hepatitis B vaccine (recombinant) (RECOMBIVAX HB). Lot number 4G2TT does not match any Company product as confirmed by Lot Verification team.
Not an ADR, but rather an error.  Patient had previously received first dose of COVID vaccination series with Moderna vaccine. Showed up for dose 2 and during check-in process was confirmed to receive Moderna and clinic staff wrote "M" on paperwork to designate Moderna vaccine was indicated. Staff member administering dose was working in a cubicle marked "Pfizer" but patient was triaged to her anyway. Overlooked the "M" on paperwork  and administered Pfizer vaccine before error was noted.  Patient noted error after 15 minute wait period (which was uneventful).  Error being reviewed by vaccine clinic staff to determine if workflow changes are needed. Case will be reviewed by vaccine clinic leadership to determine best course for completing vaccination series.
On 04/21/2021 in the morning, I started to develop a small cold sore. It began to get larger, hurt to talk or eat, I have several of them. I went to my primary care doctor on April 26, 2021. She said they are cold sores, do warm saltwater rinse.  They kept getting worse. I went to my dentist on April 29, 2021, he called a friend who is a specialist. They prescribed Magic Mouthwash. The mouthwash fixed it all.
A vial of Moderna was opened 30 days prior to administration of the vaccine on the date of 8 August 2021.    The vaccination was given outside the 12-hour use limit on punctured vials per the manufactures recommendations.   Moderna was contacted and the clinic has been informed that the members that received the vaccination is considered vaccinated since the members had the usual reactions to the vaccination.    There was no additional testing or treatment provided.  This is being reported since there was an error in the administration process.  There were no adverse reactions.
Right eye started to bother me like there was something in it.  Eyes were watering and beginning to swell.  Eye lid and surrounding tissues began to swell.  It looked its' worst early in the next morning with the eyes crusted shut from discharge.  The swelling slowly began to recede and after a visit to Dr with 24 hours on Benadryl, the symptoms were gone.  Also, I had chills and fever that first night.   This was the first flu vaccination I have had in approximately 20 years.  Previous reactions  were sore arm and mild cold/flu like symptoms.
I developed hives on my left side, my right lower eye lid and on my right wrist.
This spontaneous report was received from a nurse regarding to 7 patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored doses of M-M-R II (data digital logger) (lot # K016154, expiry: 24-SEP-2016). The vaccine was exposed to temperature: 54.4F for a time frame of 24 hours. No adverse effects were reported. There was no previous temperature excursion reported. This is one of 4 reports received from the same reporter. Additional information has been requested.
COVID Vaccine Breakthrough Case  Pfizer Dose 1 2/20/21 (lot NA) Pfizer Dose 2 3/17/21 (lot NA) COVID Positive  10/6/21 COVID Negative 11/3/21  11/3/21: The patient is a 78 year old male with past history of CVA, diabetes, hypertension, and hyperlipidemia was admitted with respiratory failure possibly secondary to COVID-19 pneumonia.  History is obtained from chart review as well as discussion with the patient and the ED provider. Patient states that he was vaccinated for COVID-19.  He states he started feeling poorly about 4-5 weeks ago and was tested for COVID-19 which returned positive.  He does not remember the exact date but thinks it was a least over 3 weeks ago.  He has felt poorly since then with generalized fatigue and weakness.  He normally receives his care at the Hospital.  It appears he may have had some oxygen at home although that seems to be unclear.  He had worsening shortness of breath and cough and present to the ER where he was found to have oxygen saturations in the 60s.  Initially required upwards of 15 L but has been weaned down to 10 L. he does state that his son is currently intubated for COVID-19 pneumonia for the last 2 weeks.  He is an insulin dependent diabetic but is unsure of his other home medications.  He denies any fevers, chills, nausea, vomiting, abdominal pain, diarrhea.  Significant chest discomfort secondary to shortness of breath yesterday.  12/9/21: Patient was then admitted with acute hypoxemic respiratory follow-up with COVID pneumonia as well as superimposed bacterial pneumonia; leukocytosis on top of chronic comorbidities.  Patient had a prolonged stay in the hospital was put on high-flow oxygen which was transition to 5 L LPM; and using CPAP.  Patient was given Decadron remdesivir Actemra and on anticoagulation.  Patient also had AKI was diuresed.  Was also treated for aspiration pneumonia.  Pulmonary team was involved in the care of the patient and patient general condition improved and was discharged with steroid Tapper and titration of oxygen currently on 5 LPM
Redness on cheek, swelling of both ears of vaccines were given. Immediately administered 0.15 mL of epinephrine. Watched pt for 10 mins. until redness and swelling went down.
At sight of injection: Extremely swollen, red, and hot to touch.  Swelling occurred all throughout the left arm and shoulder.  Fingers felt tingly and whole arm / shoulder itched.  Arm was painful to move and is still swollen at more than 5 days after injection.
Patient reported onset of chills, aches, fatigue, nausea, dizziness within 24 hours of receiving 1st dose of Moderna COVID-19 vaccine. Post COVID-19 infection onset 12/24/2020. Had been released back to work and sx free 01-04-2021.
fever; weakness; fatigue; dizziness; arm was sore for several days after the injection; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0167) via an unspecified route of administration in the left arm on 11May2021 at 13:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to animal muscle like a steak but the patient could eat eggs and broths. Concomitant medications included escitalopram (MANUFACTURER UNKNOWN) and one a day woman's multivitamin; both from an unknown date and unknown if its ongoing. The patient previously received TYLENOL for unknown indication and experienced drug allergy. The patient previously received other vaccine in four weeks which included the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0167) via an unspecified route of administration in the left arm on 20Apr2021 at 13:15 (at the age of 38-years-old) 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. On 11May2021 at 19:30, the patient got fever, weakness, fatigue, and dizziness about 5 hours after the vaccine until the following evening. The patient said that it probably lasted 18 to 26 hours. The patient's arm was sore for several days after the injection. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events fever, weakness, fatigue, dizziness and arm was sore for several days after the injection were recovered on an unknown date in May2021.   No follow-up attempts are needed. No further information is expected.
Delayed reaction began on day 5 (2/21/21) after Moderna booster. Experienced extreme fatigue, muscle and bone aches, nausea, weakness, slept most the day. 2/22 still weak, fatigued but up and about. 2/23 nausea and vomiting single episode. No fever.
Initial information received on 14-Jan-2019 regarding an unsolicited valid non-serious case received from other healthcare professional. This case involves child male patient was received vaccine QUADRACEL lot C5500CA and Exp. Date 16-Aug-2020 via unknown route in the right thigh that was not properly stored during shipment on 11-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PROQUAD for Immunisation. It was an actual medication error case due to incorrect product storage. It was reported that the vaccine was shipped on the 7th 2 days fed ex ground, should have arrived on the 9th but not delivered until the 10th. No reported reaction or side effects. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Shoulder joint pain appeared about two hours after flu vaccine and continues as of today, 9/25/17.
R/arm upper deltoid area swollen red and extremely sore to touch.  Area 2 3/4 in. x 4 1/2 in with red streaks extending from area.  14-18 red spots on both arms left and right. Was evaluated by MD and given Claritin.
Arm was painful after shot. Next day had significant redness and swelling present. Was looked at by another healthcare provider who agreed this was not a normal reaction to the shot.
This spontaneous report was received from a licensed practical nurse concerning an unspecified number of patients of unknown age and unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On unspecified dates, starting on or after 01-SEP-2015, the unspecified patients were vaccinated with improperly stored doses of GARDASIL, lot # K010215, expiration date 05-MAY-2017 (dose, dose number, route and anatomical location were unspecified). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
PATIENT DEVELOPED RASH ON LEFT ARM THE NEXT DAY AFTER VACCINATION. IT PROGRESSED TO THE OTHER ARM, STOMACH, LOWER BACK AND BOTH LEGS. CONSULTED AN RPH AFTER 2 DAYS WHO RECOMMENDED HYDROCORTISONE CREAM. PT STATES RASH CLEARED AFTER ABOUT 9 DAYS
Injection site reaction cellulitis/allergic reaction; patient has half-dollar red area with swelling about orange-sized area on back of (R) arm.
Patient arrives at the center to be vaccinated without the vaccination card since she had left it, she agrees to bring it the same day and she assures that 5 months have passed since her second dose. Relative of the patient brings the card in the afternoon to sign it and we realized that the 5 months of his second administration had not yet passed. we proceeded to call the health department, we contacted provider and she indicated to make a report in VAERS and that the president be notified of what happened. The patient is informed and indicates that she is in good health.
Swollen feet; Feet burning on the bottom; Lesions; Welts; Red marks on right leg, right knee cap; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen feet), BURNING SENSATION (Feet burning on the bottom), SKIN LESION (Lesions), URTICARIA (Welts) and ERYTHEMA (Red marks on right leg, right knee cap) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swollen feet), BURNING SENSATION (Feet burning on the bottom), SKIN LESION (Lesions), URTICARIA (Welts) and ERYTHEMA (Red marks on right leg, right knee cap). At the time of the report, PERIPHERAL SWELLING (Swollen feet), BURNING SENSATION (Feet burning on the bottom), SKIN LESION (Lesions), URTICARIA (Welts) and ERYTHEMA (Red marks on right leg, right knee cap) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
13cm x 12cm 5/10/06 received DTap injection itches warm to touch reaction started 5/11/06 Elidel RX to help with itching and ice.
This case was reported by a consumer via sales rep and described the occurrence of itching both hands in a male patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In September 2018, 1 day after receiving SHINGRIX, the patient experienced itching both hands and allergic reaction. On an unknown date, the outcome of the itching both hands was recovering/resolving and the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the itching both hands and allergic reaction to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient receive SHINGRIX vaccine in right arm. The reporter who himself a patient reported that, approximately three weeks ago next day after receiving SHINGRIX vaccination, he began to experience itching on the top and bottom of both hands. The itching was resolving slowly. Till the time of reporting, the patient was getting it less frequently. This case was previously reported to the physician. The patient called to report an allergic reaction to a medication. The patient was not looking for a resolution to the issue, so the patient did not hold it against my representative for not solving my problem that could not be solved, but it was just my reporting an issue that I was having after receiving a SHINGRIX shot. The reporter gave permission for his physician to be contacted. This case was link with case US2018GSK184601, reported by the same reporter.
Pt called on 10/15/12 to inform she is still having arm pain when she lifts her arm. I informed her to call her Dr. She saw him the next day and was given a steroid pack and has had an ultrasound with no sign of a clot. Orthopedic Dr. says Frozen Shoulder Syndrome.
keratitis in the left eye - sudden onset.   Did online medical consult for prescription treatment.
an excruciating headache; This is a spontaneous from a contactable consumer (patient). This 49-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EK9231), via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunisation. The patient's medical history included severe chronic migraine. The patient's concomitant medications were not reported. Patient stated she got her second COVID vaccine on 18Jan2021 and she has gotten an excruciating headache in Jan2021. She has taken paracetamol (TYLENOL) and 800 mg ibuprofen on 18Jan2021 and it was actually getting worse. When probed for any treatment for the problem, patient stated yes, her headache, all she had taken for 18Jan2021 so far was paracetamol, diphenhydramine hydrochloride (BENADRYL) (if might have taken for headache) and ibuprofen. Outcome of the event was unknown. No investigation assessment.
shortness of breath, elevated heart rate, elevated blood pressure, tightness in chest and heart flutter - these symptoms lasted for over 2 months after injection.  Other common side effects lasted for approximately 2 days after injection (headache, feeling very tired, muscle aches, nausea, and fever)
Rash on stomach, chest and back - 12/8/2013. Fever - 12/3/2013 through 12/6/2013.
Administered expired vaccine after the manufacture date of expiration/Dose administered after 30-day use by date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine after the manufacture date of expiration/Dose administered after 30-day use by date or after manufacturer date of expiry) in a 54-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine after the manufacture date of expiration/Dose administered after 30-day use by date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine after the manufacture date of expiration/Dose administered after 30-day use by date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. It was reported that vials had not undergone any temperature excursion. Total of 173 doses/vials were given from LOT 070H21A. Date the vial was initially stored in the refrigerator was reported as unknown. No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up contains non- significant information.
Discharge Provider: MD Primary Care Provider: DO Admission Date: 3/25/2023 Discharge Date: 3/28/2023  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Altered mental status [R41.82] Encephalopathy [G93.40] Fluctuating mental status [R41.82] COVID-19 [U07.1]   HOSPITAL COURSE:   Patient is an 86 year old female patient with PMHx for dementia, depression, Afib s/p ablation, and chronic BLE Lymphedema, who presented 3/25/2023 from her ALF due to witnessed syncopal event with associated bradycardia by EMS. Patient was found to have Metabolic Encephalopathy likely 2/2 Orthostatic +/- Vasovagal Syncope. PT and OT were consulted during this admission.    In the ED patient's vitals were notable for heart rate in the 50s.  She was otherwise afebrile, normotensive. Stroke, syncope workup were initiated. CTH did not show any acute intracranial abnormality. CTA head and neck revealed stable carotid stenosis and no large vessel occlusion. CT imaging did demonstrated diffuse lymphadenopathy throughout neck and chest, appears chronic and increased compared to November 2022 images. Labs were largely unremarkable except for a very slightly high bicarbonate and BUN in the setting of recent poor oral intake.  EKG did not show any ischemic changes. UA showing 13 squamous cells, not clean catch. Urine drug screen was negative.    Further work up demonstrated positive orthostatic vitals, further chart review notable for patient taking moderate dose Lasix BID and Toprol in the setting of mild URI symptomatic COVID. Transient confusion and syncope w/ associated bradycardia aligns with vasovagal event. BP medications and therapies prone to orthostatic hypotension were held. Patient had rapid return to baseline (A&O x2). Dose adjustment for Lasix was done and Toprol was transitioned to Lopressor. Patient was recommended to stop Memantine if patient desires, due to rare ADR of hypotension.    Patient remained afebrile, hemodynamically stable on room air on discharge at 3/28/2023.
I had a bad headache lasted for twelve hours. I took TYLENOL and it went away. I have recovered from my symptoms.
Info has been received from a licensed practical nurse concerning a 77 year old female pt with no new concomitant therapies reported and drug hypersensitivities to erythromycin (E-mycin) and clarithromycin (Biaxin) who on 11/13/2002 was vaccinated with a 1st dose of pneumococcal vaccine 23 polyvalent. On 11/15/2002 the pt developed a red blotchy rash at the injection site on her arm which resolved on its own. The pt complained of pain at the injection site and it was warm to the touch. Unspecified medical attention was sought. Pt was instructed by physician to call if symptoms worsen. No further info is expected.
reassurance given  cool compresses, Benadrly  call if worsens  will report the reaction  no problems to get the vaccines in the future   ABNORMAL inspection: right upper arm with 2 cm ecchymosis over site and slight erythema, edema, tenderness and warmth to touch.   swollen and hot to touch with tenderness  had TdaP and Men on the right  no breathing problems  no reaction to tetanus in the past
Patient presented to the emergency room 10 hours after receiving first COVID-19 vaccine with progressively worsening tongue swelling and minor shortness of breath. Patient received IV solumedrol, benadryl, pepcid and fluids. Patient's symptoms improved post treatment
I received a call from this patient's daughter in the evening sometime, maybe around 6 or 7; stated that her mother had received a pneumonia vaccine from us and it was all red and swollen. I asked if it was just at the injection site and she said, not completely, because it had become swollen down below the injection site toward the elbow. The patient had no other side effects other than the pain, redness and swelling thereof. I advised the patient to use cold compresses, diphenhydramine, and ibuprofen, if tolerable, and if not then acetaminophen. The patient arrived the next morning before we opened to show me the adverse event, it was very warm, hard, and lots of edema towards the elbow, the skin had even started to blister slightly. I advised that she go be seen by a doctor. She went to the doctor and received an oral antibiotic, cephalexin. I have since been in contact with her today, Sunday 09/25/2011, and she stated that when she came to the pharmacy, it was worse then than before. Today, she said that it is no longer painful, however it is still edematous and red. In right arm is where this occurred.
Tested positive for COVID; Tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  An 11-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Nov2021 as dose 1, single (Lot number: FK5127), in left arm and on 26Nov2021 as dose 2, single (Lot number: FK5127) at the age of 10 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Apr2022, outcome "not recovered" and all described as "Tested positive for COVID". The event "tested positive for covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Apr2022) Positive, notes: COVID test type post vaccination: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical course: The patient did not have COVID prior vaccination.