chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered from a vial that was punctured 24 hours ago; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered from a vial that was punctured 24 hours ago) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) 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 12-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered from a vial that was punctured 24 hours ago). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered from a vial that was punctured 24 hours ago) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
11SEP91 pt exp h/a, nausea, lump behind rt ear, aching knees & hips; Advised to inform MD; 14SEP called MD instructed to come in on 18SEP if not improved; 30SEP pt stated had bump looked at when took daughter for an appt;
No adverse reaction. Patient received monovalent, instead of bivalent dose due to labeling error on the part of the staff member who opened the vial for the day.
Pain in shoulder, limiting arm movement laterally. Two months after flu shot, went to Dr, had xray (negative), received cortisone shot in shoulder. Pain worse for 2 days, then reverted to prior condition (painful lateral movement). Still the same pain 10 weeks after flu shot.
Info regarding Prevnar vaccine was received from a healthcare professional regarding a 15 month old female pt who experienced injection site cellulitis. The pt received the fourth dose in 5/2005. The pt's concurrent illnesses include dermatitis atopic and urinary tract infection. Indication for Prevnar was immunization. Product was administered in 5/2005. Dose regimen was 1 dose, IM. Concomitant medications were not provided. Event Details: The pt experienced injection site cellulitis on 5/11/05. Site of administration was the left thigh. The pt recovered (May-2005). No additional info was available at the time of this report.
The patient complained of burning and the administration was stopped. The patient received only 0.2 mL of the dose.; She got MMR-II yesterday, about 0.25 ml / The patient received only 0.2 mL of the dose.; This spontaneous report was received from a pharmacist referring to a 38-year-old female patient (conflicting information, also reported as "male"). Information regarding the patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies was unknown.  On 19-FEB-2021, the patient had to received once a dose of 0.5 milliliter (ml) injected of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (strength, vaccination scheme frequency, exact route of administration, and anatomical location were not reported; lot number reported as T007232, had been verified to be a valid lot number, expiration date reported and upon internal validation established as 27-FEB-2022) as immunization, however, the pharmacist stated that approximately 0.25 ml of the vaccine dose remained in the syringe (conflicting information, also reported that "the patient received only 0.2 ml of the dose") (incorrect dose administered), because the patient informed the healthcare provider who administered the vaccine that it was burning (vaccination site pain), and so the needle was pulled out. Additionally, it was unknown if the patient will receive the remainder of the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) and it was reported that the patient needed varicella virus vaccine live (Oka/Merck) (VARIVAX) but she could not wait 28 days for varicella virus vaccine live (Oka/Merck) (VARIVAX) because she would be out of the country. It was unknown if the patient received treatment for the adverse event, if laboratory diagnostics or studies were performed, or if the patient sought medical attention.  The outcome of the event vaccination site pain was unknown. The reporter considered the event vaccination site pain to be related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II).
Pt. was given MenCYQ-135 Liquid Conjugate Component only and it was to be mixed with the lyophilized component.  No reaction or symptoms noted after injection.   Pt. reported he was not expecting to travel outside of country and according to instructions and indications on vaccine site, the liquid conjugate is sufficient and needs not be repeated.  I contacted the clinic and they are advising as to whether the vaccine needs repeated d/t patient being of high school age.  I advised patient does not attend a school facility but is on home bound school.  If advised to repeat, will call patient to return to clinic for repeat vaccine.
(11/23/2021) Early morning was awaken with alternating chills and hot flashes(sweats) that lasted about 2hrs before I could return to sleep. The following 14 hrs had chills and fatigue. The following day around 7:30am had a event where my mucos plug and a small amount of amniotic fluid came out, called OBGYN nurse was advised to keep watch if any changes happen. Cramps on the evening of the 24th that still continues to this day. Later on 11/25 small amounts of dark blood spotting and as the day progressed around 3:00PM CT it changed to red blood and went to the ER. There they did blood work and Ultrasound. Blood work came back fine but UltraSound showed the baby was only 5wk 6days but was already at week 8. (week 5 was before the booster) NOTE: In first trimester morning sickness was light compared to my previous pregnancy. EST DUE DATE: July 6, 2022
Patient is a 51 y.o. female patient of MD with history of lupus, rheumatoid arthritis, asthma, migraine, depression, anxiety transferring to to Medical Center with acute hypoxemic respiratory failure due to COVID pneumonia.   Acute hypoxemic respiratory failure Secondary to recent COVID PNA, underlying OSA/OHS Requiring 3L NC on admission, no baseline requirement CTPA 10/20 w/patchy bilateral infiltrates Aggressive pulmonary hygiene Wean O2 as able to maintain SpO2 88-92% Qualified for home O2 10/22, F2F completed Pulm/CC consulted   Covid-19 Virus Infection Date of onset of symptoms: 9/29 Symptoms present on admission: SOB, cough, weakness Date of covid positive test: 9/29 Vaccination status: Vaccinated, booster x1 Imaging: CTA w/patchy bilateral interstitial infiltrates Oxygen requirements on admission: 6L Current oxygen requirements: 3L Medical therapy: Decadron Consultants following: Pulmonary, ID CRP elevated 308 No indication for ongoing isolation    Bacteria PNA Pt reports subjective fevers and diaphoresis No SIRS/Sepsis criteria on admission MRSA probe, PCR antigens pending  Cefepime, Flagyl ordered on admission Flagyl stopped 10/21 Changed to Levaquin on DC, to complete 7D total   AKI, resolved Likely pre-renal secondary to poor intake Cr 1.28 on admission, baseline WNL Cr normalized 10/21 UOP remains adequate Limit nephrotoxins as able Daily RFP    Asthma, w/o acute exacerbation Stable, at baseline Continue Symbicort, Singulair Needs PFT as OP   History of lupus History of rheumatoid arthritis Continue home medications; Plaquenil and Arava  Methotrexate recently discontinued, has not started Baricitinib Multimodal pain management   History of depression Continue home medications   History of migraine headaches Sumatriptan as needed   GERD  Cont pantoprazole    OSA/OHS Suspected based on snoring, non-restful sleep Home PSG per Pulm   Morbid Obesity BMI 53.27 Weight loss, lifestyle modifications encouraged
Patient presents with C/O cough, runny nose, a raspy voice and fatigue. She states that she developed her symptoms after she received the pneumonia vaccine. The first symptoms were fatigue and cough that started about 24 hours after her vaccination. Symptoms coincide with patient receiving the PNEUMOVAX; Reassured patient that symptoms will improve. Advised her to take NSAID for her Sx.
Very high fever ranging from 102-106 for about 48 hours, followed by fever ranging from 99.5-102.5 for another 48 hours. Alternated Tylenol and Advil at appropriate max doses, placed iced towels on head and under armpits.  Sever headache that could not be relieved for about 60 hours. Had to keep eyes closed a lot of the time.  Chills and shivering during times of high fever Severe muscle and joint aches and sensitivity to touch Extreme fatigue  These are the same exact side effects I had when I had covid the end of October 2020, but then I had these symptoms for 12 days versus 4 days.  I had an appointment to receive the second dose on April 6 2021, but after consulting g with my healthcare provider, she recommended that I wait until June and test my antibody levels first, due to the severe side effects  from when I had covid and the the first dose of the Vaccine.
Headache, fever (100.8), chills, joint aches, muscle soreness.
MOC REPORTS THAT SHE NOTICED PATIENT HAVING TIC LIKE SYMPTOMS, WHICH WERE EYES BLINKING OF BOTH EYES AND MOUTH (GRIMACING) MOVEMENT.   THE ONLY CHANGE THAT SHE REPORTS WAS THA PATINET RECENTLY  HAD VACCINES GIVEN.  NO OTHER CHANGE  NOTED.  HOWEVER, PATIENT  HAD A HIGH FEVER OF 101 AND DIAGNOSED WITH PHARYNTONSILITIS ON 9/16/2022.  SEEN IN ER 0N 9/17/2022 AND DX WITH NAUSEA/VOMITING AND WATERY DIARRHEA.
itching, red spots all over - started evening of 1/27 - called pharmacy morning of 1/28 - i advised that she take benadryl or claritin.
9 year old male patient was given an expired Quadracel vaccination, no AE; Initial information received on 09-Sep-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 9 year old male patient who was vaccinated with an expired dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (expired product administered).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   No other medications or vaccinations were given at this visit.  On an unknown date, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot C5325BA and expiry date: 14-Nov-2019) via an unknown route in the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used.  At the time of report, no adverse event was reported.  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.
Intense hives occurred 5h post injection on scalp, arms, legs, neck, and most severely on the lower abdomen.; This is a spontaneous report from a contactable healthcare professional, the patient. A 41-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the right arm on 18Apr2021 at 12:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included allergic to deodorant, laundry detergents and had been exposed to PEG in lab environment. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 18Apr2021 at 17:00, 5 hours post injection, the patient experienced intense hives on scalp, arms, legs, neck and most severely on the lower abdomen and there was no injection site reaction nor any other side effects. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event intense hives on scalp, arms, legs, neck, and most severely on the lower abdomen were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Stated - she had "welts"/rash on abdomen/chest/back - occurred x2 days after vaccine administered.
The HCP noticed that there was still approximately half volume of the vaccine inside the vial, so instead of the vial containing 0.25 ml as indicated in the label, vial contained approximately 0.5 ml; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (The HCP noticed that there was still approximately half volume of the vaccine inside the vial, so instead of the vial containing 0.25 ml as indicated in the label, vial contained approximately 0.5 ml) and NO ADVERSE EVENT (No adverse event) in a 1-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. AU5509B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Oct-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) .25 milliliter. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (The HCP noticed that there was still approximately half volume of the vaccine inside the vial, so instead of the vial containing 0.25 ml as indicated in the label, vial contained approximately 0.5 ml) and NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (The HCP noticed that there was still approximately half volume of the vaccine inside the vial, so instead of the vial containing 0.25 ml as indicated in the label, vial contained approximately 0.5 ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (The HCP noticed that there was still approximately half volume of the vaccine inside the vial, so instead of the vial containing 0.25 ml as indicated in the label, vial contained approximately 0.5 ml).    Concomitant medication was not provided. HCP stated that they received a shipment of single dose vials of Moderna COVID-19 Vaccine for 6 months to 11 years and on 02-OCT they used 1 vial to administer 1 dose to a patient. After 1st dose was withdrawn from the vial and administered to the patient (without AEs reported), the HCP noticed that there was still approximately half volume of the vaccine inside the vial, so instead of the vial containing 0.25 ml as indicated in the label, vial contained approximately 0.5 ml. HCP mentioned this was the only vial they have been thawed so far, and they still have 9 vials from the same shipment in the freezer, and the caller stated that the rest of the vials seemed to have the same volume than the first one, but she was not sure since the rest of the vials are not thawed yet. Treatment information was not reported.   Reporter did not allow further contact
Colon inflammation; This spontaneous case was reported by a physician and describes the occurrence of COLITIS (Colon inflammation) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 004M20A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    The patient's past medical history included Tobacco user from 1965 to 30-Apr-2006, Bowel resection in 1980, Gallbladder removal, Colonoscopy on 15-Apr-2021 and Renal surgery. Concurrent medical conditions included Ulcerative colitis, Kidney infection, Pollen allergy (manifested by eyes watery, nose runs, sinus headache,dizzy), Respiratory disorder NOS, Bladder disorder NOS, Restless leg syndrome, Vitamin D low, Crohn's, Blood pressure high, Emphysema, Blood cholesterol abnormal, Allergy, Depression and Somnolence. Concomitant products included SALBUTAMOL SULFATE (PROAIR [SALBUTAMOL SULFATE]) for Abnormal breathing, MONTELUKAST SODIUM (SINGULAIR) and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergy, AZITHROMYCIN (AZO) for Bladder disorder NOS, FENOFIBRATE for Blood cholesterol abnormal, ATENOLOL and AMLODIPINE for Blood pressure high, CHOLESTYRAMINE and PREDNISONE for Crohn's, ESCITALOPRAM for Depression, TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) for Emphysema, CARMELLOSE SODIUM (THERATEARS) for Eye disorder NOS, FLUTICASONE for Nasal disorder NOS, FOLIC ACID for Nutritional supplement, IPRATROPIUM BROMIDE, CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and AZELASTINE for Respiratory disorder NOS, GABAPENTIN and ROPINIROLE for Restless leg syndrome, MODAFINIL for Sleepiness, POTASSIUM CHLORIDE, TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) and CENTRUM SILVER WOMEN 50+ for Supplementation therapy, VITAMIN D NOS for Vitamin D low and Supplementation therapy, ESTROGENS CONJUGATED (PREMARIN), MELOXICAM and ACETYLSALICYLIC ACID (ASPIRIN LOW) for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 15-Apr-2021, the patient experienced COLITIS (Colon inflammation). At the time of the report, COLITIS (Colon inflammation) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Patient devloped tingling sensation of her face and subsequently developed herpes zoster of the left eye
I had some extreme symptoms after my vaccine. Right after I got the vaccine, I had some soreness which didn't worry me. But then as the day went on, I got a fever of 103F and extreme body aches. I could barely sleep or get out of bed. I was very dizzy and very weak. I had chills and sweats. I was either really cold or really hot, no in between. I was fatigued for a week after the vaccine. I had shortness of breath and I got my vaccine on a Friday and was sick throughout the entire weekend until Tuesday.
After second vaccine: light-headed, chills, hot, muscle aches, headache, light feeling
Dizziness, Headache, fatigue Narrative: Received 1st covid vaccine today at 0630, started experiencing a "massive headache", tiredness, fatigue, dizziness. Employee was advised that these can be normal side effects as listed on VIS sheet. Should resolved in a couple of days.
covid arm - swollen, red, itchy, tender injection site reaction that presents itself days after the initial injection.  In this instance, the reaction occurred 7 days after vaccination.
Severe itching; Numbness of lips, tongue and mouth roof; Flushing; tachycardia; anxiety; Possible worsening of eyesight on right eye; This is a spontaneous report from a contactable nurse, the patient. A 56-Year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: En6207) via an unspecified route of administration in left arm on 11Mar2021 at 09:00 hrs (at the age of 56-Year-old) as a single dose for COVID-19 immunisation. Medical history included fillers 3 weeks before vaccine and patient had both. Past drug history included lisinopril from which patient had allergy. Patient received unspecified concomitant medications within two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11Mar2021 at 09:15 hrs, patient experienced severe itching, numbness of lips, tongue and roof of mouth, flushing, tachycardia, anxiety and possible worsening of eyesight on right eye. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events severe itching, numbness of lips, tongue and roof of mouth, flushing, tachycardia, anxiety and possible worsening of eyesight on right was resolved. No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a licensed referring to a 15 month old male patient. The patient did not have concurrent conditions, drug reactions or allergies or medical history. The patient was not taking any concomitant medications. On 26-JUN-2017, the patient was vaccinated with the first dose of M-M-R II, for prophylaxis (dose, route of administration , lot #, and expiration date were not reported) diluted in sterile diluent (MRK) (dose, route of administration, lot number and expiration date were not reported) at age of 12 months. On 03-OCT-2017, the patient received the second dose of M-M-R II, lot # reported as N004933 with expiration date of 07-FEB-2019, for prophylaxis (dose, and route of administration were not reported) diluted in sterile diluent (MRK) (dose, route of administration, lot number and expiration date were not reported), when he was 15 months old. Then, 2 hours after the injection on the same day, the patient vomited for 5 times. No treatment was given for the adverse events and no laboratory tests were performed. No product quality complaint was involved. At the time of reporting, the outcome of the event of vomiting was unknown and its causal relationship between it and therapies with M-M-R II and sterile diluent (MRK) was not reported.
Erythema with swelling to top of left thigh around to inner thigh, approx. 3 cm in diameter, warm to touch and painful.
Information has been received on 11/15/01 from a physician concerning a 33 year old Hispanic female who "since 1995" was vaccinated with a 1st, 2nd and 3rd dose of MMRII. The pt received the 1st 2 doses from her physician "around 1995". A measles titer was done in 12/98 and was found to be negative. It was reported that another immunization was given on 2/1/99. A titer was drawn in 8/99 which again revealed lack of sero-conversion. It was noted that the pt did sero-convert on mumps and rubella. The pt sought unspecified medical attention. It was reported that the reporting physician opted not to give the pt a 4th dose. No further information is expected.