chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the vial expired on 17-Apr-2022, initially stored in the refrigerator on 04-May-2022 and administered on the same day; 25 doses of expired Moderna Covid-19 vaccine were administered to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna Covid-19 vaccine were administered to patients) and PRODUCT STORAGE ERROR (the vial expired on 17-Apr-2022, initially stored in the refrigerator on 04-May-2022 and administered on the same day) in an 85-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna Covid-19 vaccine were administered to patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial expired on 17-Apr-2022, initially stored in the refrigerator on 04-May-2022 and administered on the same day). At the time of the report, EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna Covid-19 vaccine were administered to patients) and PRODUCT STORAGE ERROR (the vial expired on 17-Apr-2022, initially stored in the refrigerator on 04-May-2022 and administered on the same day) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment information was not reported.  The vial did not undergo any temperature excursions.  On 04-May-2022, the patient received full dose of Moderna COVID-19 vaccine.
Patient reports that arm became warm red and swollen approximately 1-1 1/2 hours after shot was given, redness continued to spread the following day with blotchiness on arms, patient also complained of a headache. Today 10/29 patient was seen in clinic,  and redness has decreased, no C/O headache.
Patient came in to see employee for a WV on 10/17/23 at 8:30am. After I put in the vitals(HC,Length,Lbs) nurse came in for the appointment. He spent the normal time with the PT and mom, and came out to tell me what shots she would need. I drew up all the shots he put in, including the new Covid for 6 months to 4 yr. ??????Contents of Pfizer Covid vaccines 6 months/ 4-year, yellow cap drawn into syringe. Administered to patient in right deltoid. Shortly after administration, realized that the vial is a 3-dose vial, to be reconstituted with saline. I informed my manager and the provider.
Patient is a 38 year old female with hypertension, diabetes,12 week IUP, received second dose of Pfizer today. Patient had mild nausea and vomiting after receiving the vaccination. Patient then c/o lower abdominal cramps.  Patient was last treated for UTI on 2/10/2021. Patient denies dysuria and frequency today. Denies fever, chills Denies vaginal spotting or bleeding. Denies diarrhea or constipation.  Patient stopped taking atenolol after she got pregnant. Home blood pressure has been ranging from 110's to 130's systolic and 70's to 90's diastolic at home.     Denies: Chest pain, DOE, SOB, headaches.       OBJECTIVE: BP (!) 137/101 (BP Location: RA-RIGHT ARM, BP Patient Position: SITTING, Cuff Size: Standard Adult)  | Pulse 91  | LMP 11/21/2020 (Exact Date)    GENERAL APPEARANCE: alert and oriented x 4, in no acute distress.    HEENT: pupils equally rounded and reactive to light, extra ocular motor intact, tympanic membrane intact   CHEST: Clear to auscultation, no wheezes, rales or rhonchi    CVS: Regular rate and rhythm, normal S1, S2, no murmur. Symmetric, brisk pulses   ABDOMEN: soft, mild suprapubic and left lower quadrant tenderness, non-distended, no rebound, no guarding, bowel sound x 4   EXTREMITY: no clubbing, cyanosis, and edema    UA: negative nitrite, negative leukocyte, small blood   ASSESSMENT Encounter Diagnoses Code Name Primary? ? Z23 VACCINATION FOR SARS-COV-2   ? R10.9 ABDOMINAL PAIN   ? I10 HTN (HYPERTENSION)   patient's lower abdominal cramps were most likely due to anxiety and vomiting.  Patient's abdominal pain subsided in clinic.      PLAN:    Orders Placed This Encounter ? Dose #2- VACC COVID-19, MRNA, LNP-S, PF (PFIZER-BIONTECH) ? Labetalol (NORMODYNE/TRANDATE) 100 mg Oral Tab ? URINALYSIS, DIPSTICK, POCT   Advised the patient to monitor for symptoms of abdominal cramps and vaginal bleeding. Contact obstetrics clinic for acute symptoms. Advised the patient to take labetalol 100mg two times a day as needed for BP > 135/90. Keep herself well hydrated.   Advised the patient to call for worsening symptoms. Patient verbalized understanding.
This case was reported by a other health professional and described the occurrence of incorrect storage of drug in a patient who received KINRIX. Co-suspect products included HAVRIX and ENGERIX B. On an unknown date, the patient received KINRIX at an unknown dose, HAVRIX at an unknown dose and ENGERIX B at an unknown dose. On an unknown date, an unknown time after receiving KINRIX, HAVRIX and ENGERIX B, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information received: Unstable KINRIX, HAVRIX and ENGERIX were administered. HCP does not have additional patient info for AE.
Information has been received from a 29 year old female health professional, with no medical history and no allergies, who on 03/15/2005 was filling a syringe with varicella virus vaccine live and got some in her eye.  There was no concomitant medication.  She reported that there was some burning, but the burning went away after a few seconds.  The patient reported her status as recovered.  There were no laboratory or diagnostic tests performed.  Unspecified medical attention was sought.  No product quality complaint was involved.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/16/2005. Information has been received from a 29 year old female, health professional, with no medical history and no allergies, who on 15-MAR-2005 was fillling a syringe with VARIVAX (Merck) and got some in her eye. There was no concomitant medication. She reported that there was some burning, but the burning went away after a few seconds. The patient reported her status as recovered. There were no laboratory or diagnostic test performed. Unspecified medical attention was sought. No product quality complaint was involved. Follow-up information received from a health professional indicated that a co-worker shot a little vaccine in her eye and she experienced some stinging in the eye right after. There were no other symptoms afterwards. Additional information is not expected.
administered an expired /BEXSERO (exp date: 05/31/2021) on the 24th June, 2021; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a female patient who received Men B NVS (Bexsero) (batch number unknown, expiry date 31st May 2021) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 24th June 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 24th June 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient was administered an expired dose of Bexsero, which led to expired vaccine used. No further details were provided at the time of call. The reporter did not have the lot number of the vaccine, date of birth or age of the patient.  The reporter consented to follow up.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 16-OCT-2012 10:36, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Swelling at site, redness and inability to move arm higher than chest level about 4 hrs after vaccination. Patient had ice pack with no barrier on arm wrapped in ace bandage. I advised her not to ice especially with ace bandage. Advised her to take ibuprofen and BENADRYL and use topical hydrocortisone and apply cold compress no more than 15 minutes at a time.
COVID-19 symptoms started 07/31/2022; tested positive on 08/01/2022. Sunday evening is when it started and I felt like I was getting a cold with a stuffy nose. I tested in the morning and I was positive and in 1-2 days it was a sore throat and I am still raspy but it doesn't hurt and only lasted 2-3 days. I called my doctor and was prescribed PAXLOVID and I took that for 5 days.
pt recvd vax;started crying uncontrollably; fever; to er; rectal T of 102; recvd apap; mom reports that pt cried from about 7pm-11pm;
1-27-15 started with a small red area under injection site and gradually increased to 9 cm x 11 cm on the day she presented at clinic. Area red and warm to touch. It is not raised or painful. She came to clinic on 2-2-15. Advised to try OTC BENADRYL and observe for changes. Area completely gone by 2-5-15.
This spontaneous report as received from a healthcare worker refers to a 70 years old female patient (age at the time of reporting). On an unknown date, the patient was vaccinated with ZOSTAVAX. The dose, route and lot number were not provided. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient developed a huge water blister the size of a lemon, at the injection site. No treatment information was reported. The outcome of huge water blister the size of a lemon, at the injection site was unknown. The relatedness for huge water blister the size of a lemon, at the injection site was unknown for ZOSTAVAX. This is one of several reports from the same source. Additional information has been requested.
Initial misuse report received from a health care professional on 03 October 2013. An 81 year old male patient had received FLUZONE HD subcutaneous route. No adverse event was reported. List of documents held by sender: none
2-14-06 Patient's mom reports child cried from 4am-8am unconsoleable. Slept well after that.  Alert and playful. Red rash on face 2-13-06 prior to vaccine given on 2-14-06 rash spread to trunk with feet and hands bright red and swollen. Mother declined appt so no treatment given.
This is a spontaneous report from a contactable consumer, the patient. A 49-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08Apr2021 at 14:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 in the second week of Nov2020. The patient had no known allergies. Concomitant medication included birth control (unspecified) from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine.  The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Mar2021 at 14:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. On 15Apr2021 at 16:30, a few weeks later, the patient noticed that almost all of her food tasted different. The first time she really noticed was on Thursday (also reported as 15Apr2021), when she was drinking red wine and it tasted so different and it was not good. Since then, the patient had tried more red, as well as white wine and they did not taste good and tasted totally different. Most things that the patient ate and drank, did not taste the same. It tasted like nothing she could describe. The lemons smelled weird, cucumbers and red peppers tasted different. Tacos tasted weird and grilled burgers smelled weird. The patient wished that she could explain the taste and smell but it was nothing that can be described that was similar. It just smelled like bad food and the actual flavor that the patient used to taste, was very different. Almost like the food was going bad and was not sure if that was accurate. It just smelled and tasted worse than the flavor the food should be. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events noticed that almost all of food tastes different and lemons smell weird / grilled burgers smell weird was not resolved at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Weakness to lower extremities, seen and treated, diagnosed with Guillain-Barre.
This spontaneous report was received from a Nurse refers to a 24 year old female patient. On 12-MAR-2014, the patient while pregnant was vaccinated with GARDASIL lot # J006850 (Expiry: 31-MAR-2016), 0.5 ml, intramuscular. Concomitant medications included sertraline hydrochloride and fluconazole. The patient was sought medical attention and was at physician office when she received the vaccine. The patient underwent unspecified pregnancy test, unspecified blood work and pap smear. It was reported that the patient last menstrual period was on an unknown date last month. No adverse effects reported. No further information provided. Additional information has been requested.
Patient received 2nd dose of Moderna vaccine today (6/12/21) and experienced shortness of breath, raspy voice, visible redness/swelling to face, difficulty speaking approximately 1-1.5 hours post vaccination. She received the 1st Moderna dose on 5/14/21  and did not experience any significant adverse events (only experienced arm pain, redness/swelling at site of injection).   Administered epi 0.3mg IM x1, diphenhydramine 50mg IV x1, Solu-Medrol 125mg IV x1, famotidine 20mg IV x1, albuterol 5mg neb x1, and NS 1L bolus for anaphylaxis treatment in the ED.  Also O2 4L/min per oxymask.
symptoms began late at night the day of the vaccination - aches, very sore arm, flulike, brief interlude of dizziness and nausea, extreme fatigue until the next evening; symptoms began late at night the day of the vaccination - aches, very sore arm, flulike, brief interlude of dizziness and nausea, extreme fatigue until the next evening; symptoms began late at night the day of the vaccination - aches, very sore arm, flulike, brief interlude of dizziness and nausea, extreme fatigue until the next evening; symptoms began late at night the day of the vaccination - aches, very sore arm, flulike, brief interlude of dizziness and nausea, extreme fatigue until the next evening; symptoms began late at night the day of the vaccination - aches, very sore arm, flulike, brief interlude of dizziness and nausea, extreme fatigue until the next evening; symptoms began late at night the day of the vaccination - aches, very sore arm, flulike, brief interlude of dizziness and nausea, extreme fatigue until the next evening; This is a spontaneous report from a non-contactable consumer (patient, self-reported). A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Right, on 27Jan2021 at 11:00 AM, as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history slightly underachieve thyroid otherwise good health and known allergies: Penicillin derived antibiotics - gastric symptoms not full allergic reaction. Concomitant medications were not reported. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient reported that on 28Jan2021 at 01:00 AM, her symptoms began late at night the day of the vaccination - aches, very sore arm, flulike, brief interlude of dizziness and nausea, and extreme fatigue until the next evening. The patient did not receive any treatment for the events. Outcome of the events was recovering.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
THERE WERE NO ADVERSE EVENTS THAT WE ARE AWARE OF  THE PATIENT DIED 06/11/09 WITH MEDICAL RESULTS PENDING  I WAS TOLD I NEEDED TO FILL OUT REPORT REGARDLESS OF LACK OF PROOF THAT VACCINATION CONTRIBUTED WITH HIS DEATH.  8/31/09 Autopsy Report received. DOD 6/11/09 Cause of Death: Sudden Infant Death Syndrome (SIDS). Manner of Death: Natural.
Arms, legs and head started shaking so rapidly up in the air; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Arms, legs and head started shaking so rapidly up in the air) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016MZ0A and 029L20A) for COVID-19 vaccination.     The patient's past medical history included Suspected COVID-19 (She possibly had covid-19 in march 2020 and was on oxygen for 2 months.) in March 2020 and Oxygen therapy (Was on oxygen for 2 months.) in March 2020. Concurrent medical conditions included Penicillin allergy, Allergy to antibiotic and Drug allergy (Allergic to most of the medications including antibiotics and many more.).   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TREMOR (Arms, legs and head started shaking so rapidly up in the air) (seriousness criterion hospitalization). On 14-Feb-2021, TREMOR (Arms, legs and head started shaking so rapidly up in the air) had resolved.            Concomitant product use was not provider by the reporter.  Treatment included unspecified pain medication, shots and IV fluids.  Patient started to experience event by 11 PM on 13 Feb 2021 and patient was presented at emergency room and by 7 AM next morning patient experienced same event and admitted at the hospital for 7-8 hours.  Company comment: This case concerns a 74-year-old female patient with relevant medical history of covid-19 (March 2020) and Allergic to most of the medications who experienced serious, unlisted event of tremors. The event occurred same day after 2nd dose of Moderna COVID-19 Vaccine.  The events were considered related to the product by the reporter. The rechallenge was not applicable as the event occurred after the 2nd dose. The history of "Allergic to most of the medications" may remain a confounder. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.   This case was linked to MOD-2021-321057 (Patient Link).; Sender's Comments: This case concerns a 74-year-old female patient with relevant medical history of covid-19 (March 2020) and Allergic to most of the medications who experienced serious, unlisted event of tremors. The event occurred same day after 2nd dose of Moderna COVID-19 Vaccine.  The events were considered related to the product by the reporter. The rechallenge was not applicable as the event occurred after the 2nd dose. The history of "Allergic to most of the medications" may remain a confounder. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
Vomited x t 20 minutes after injections: no previous signs of illness. Did not cry or get upset regard vaccines.
This spontaneous case, initially received on 14-Feb-2018, was reported by a physician and concerns an adult male patient of unspecified age. The patient's current conditions included asthma (since an unspecified date). On an unspecified date, the patient was administered with INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date (reported as once in past 40 years), the patient had flu after flu vaccination. The outcome of the event was not reported.
Potentially received doses that have undergone temperature excursions; Vials were stored in an ultra low freezer at -70 ºC for probably 2 weeks.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Potentially received doses that have undergone temperature excursions) and PRODUCT STORAGE ERROR (Vials were stored in an ultra low freezer at -70 ºC for probably 2 weeks.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.     No Medical History information was reported.  On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Potentially received doses that have undergone temperature excursions) and PRODUCT STORAGE ERROR (Vials were stored in an ultra low freezer at -70 ºC for probably 2 weeks.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Potentially received doses that have undergone temperature excursions) and PRODUCT STORAGE ERROR (Vials were stored in an ultra low freezer at -70 ºC for probably 2 weeks.) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   No treatment information was provided.
On 3-17-20201 at 9:45pm. Severe neck and muscle pain , SEVERE body shakes that lasted til 3am then I was extremely hot with 102.9 fever did I not sleep all night.  My hands would not work they were extremely painful. My sugar went to over 200 which was high for me.  At 6am Motrin was taken and after 2 hrs temperature came down to 98.6.  At 10am shakes started again and finally stopped at 5pm.  My skin on hands and neck were burning.  Unable to move fingers well until now at 5pm.
Pt fainted as walked toward door out of office. Momentarily felt dizzy - rested in office about 1/2 hr.  Struck brow area, saw opthamologist - neg findings.
I received the vaccine on 06/27/2022. Later that night arm was sore. A week later in the evening I started having intense itching. next day around my groin area , right lower arm inside wrist I noticed I had hives on chest neck and back and hair. On July 5 I went to the doctor and my skin was very warm to touch and itching. I was prescribed Prednisone  tab decreasing over a period of  12 days. I was was offer Hydroxyzine  for 30 days. Still have contact dermatologist still visible. skin a little more sensitive. I was diagnosed with allergic urticaria.