chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no antibodies developed from the COVID vaccine; rash at injection site after first dose; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (no antibodies developed from the COVID vaccine) and VACCINATION SITE RASH (rash at injection site after first dose) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis (primary progressive). Concomitant products included FAMPRIDINE (AMPYRA) and OCRELIZUMAB (OCREVUS) for Multiple sclerosis, MOMETASONE FUROATE (ASMANEX), SALMETEROL XINAFOATE (SEREVENT), MIRABEGRON (MYRBETRIQ), ATORVASTATIN and TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF) for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE RASH (rash at injection site after first dose). On an unknown date, the patient experienced DRUG INEFFECTIVE (no antibodies developed from the COVID vaccine). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, DRUG INEFFECTIVE (no antibodies developed from the COVID vaccine) and VACCINATION SITE RASH (rash at injection site after first dose) 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.   Concomitant products included MOMETASONE FUROATE (ASMANEX), SALMETEROL XINAFOATE (SEREVENT), MIRABEGRON (MYRBETRIQ), ATORVASTATIN, TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF), FAMPRIDINE (AMPYRA) and OCRELIZUMAB (OCREVUS). Treatment products include Tylenol.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-033043 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Report from other manufacturer, additional AE.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-033043:Second Dose Case
covid; covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), 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), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "covid". The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
This spontaneous report as received on 30-OCT-2015 from a 74 year old male patient refers to himself. No medical history, concurrent conditions and concomitant therapies were reported. On 27-OCT-2015, the patient was vaccinated with PNEUMOVAX 23 subcutaneously (lot number, dose and anatomical location were not reported). On 28-OCT-2015 (reported as "the next day"), the patient experienced chills, headache, body aches, redness and soreness in his biceps area and feeling hot without having fever. No lab results were reported. On an unknown date, the patient sought medical attention and visited physician's office. Subsequently, he received treatment with BENADRYL (dose, frequency, route of administration were not specified). The outcome of feeling hot, headache, injection site pain, injection site erythema, chills and pain was reported as recovering. No product quality complaint was filed. The relatedness between events and PNEUMOVAX 23 was not reported. Additional information is not expected because no contact information was provided.
Patient vaccinated with Moderna on 02/18/2021 and 03/18/2021, hospitalized on 9/29/2021 for covid 19 pneumonia.
L arm/hand  paresthesia (tingling sensation) - no loss of motor strength, sensation intact. No respiratory sxs, no rash.
Sore throat; Chills; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), CHILLS (Chills) and MYALGIA (Body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), CHILLS (Chills) and MYALGIA (Body aches). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), CHILLS (Chills) and MYALGIA (Body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
30JUL92 in the AM recvd 1st dose of Engerix-B & in the PM same day devel h/a & upset stomach; 31JUL92 devel bilateral swollen lymph nodes (painful) in the jaw area; 2AUG92 devel severe nausea & was unable to open jaws completely;
Expired Covid vaccine administered to patient      Event details:  o         Vial opened on Wed 2/16 at 3pm; Vial was dated/labelled. Evening nurse was to take the booster, then discard. At the end of shift she refused booster, but vial wasn?t discarded/waisted.  o         Opened vial was refrigerated, dated/initialed.  o         CN/CM were at another clinic due to bad weather. A nurse from another clinic offered to help with vaccinations and gave a booster dose was given to 3 employees from opened vial.  o         Vaccines given Friday 2/18 at 3pm to patient   o         CM/CN noted there was still one unopened vial left in refrigerator on Monday 2/21/2022
Severe body aches and chills that caused moderate shivering for roughly 3 hours, 17 hours after injection, from 8am-12pm. Felt fine from 12pm-3pm then began experiencing very mild body aches, fatigue, and mild nausea from 3pm-8pm. Felt fine the following day.
Information has been received from a health professional concerning an 18 year  old female who was vaccinated with Gardasil. Subsequently, the patient experienced injection site pain. Additional information has been requested.
This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. There was no concomitant medication. Information about concurrent conditions and medical history was not provided. On 25-APR-2017 at 10:00 am, the last recorded temperature of the vaccines was 4 Celsius degree. On the same day at unspecified time, the ROTATEQ were discovered out of temperature range (refrigerator temperature was 12.7 Celsius degree). The vaccines were not moved to a working refrigerator post the event. It was also reported that the vaccines experienced a temperature excursion during 1 hour 17 minutes. No previous temperature excursion was reported. A data logger issue was involved. On 11-MAY-2017, the patient was vaccinated with improperly stored doses of ROTATEQ (lot number M039067 with expiration date of 18-APR-2018; strength and dose were unknown; location was also reported as "2", dose number was also reported as "0"; Vaccines for Children Program (VFC) stock) orally for prophylaxis. The nurse sated that they would monitor every 30 minutes to insure temperature with range. It was confirmed the vaccines were OK to use. There was no adverse event reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA014144:
Patient may have inadvertently been given 1cc of Moderna COVID vaccine instead of 0.5cc. Patient was notified. State was notified.
Less than a full dose was received by the patient.; Less than a full dose was received by the patient.; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Less than a full dose was received by the patient.) and DEVICE CONNECTION ISSUE (Less than a full dose was received by the patient.) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016C21A and 023C21A .) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 21-May-2021, the patient experienced UNDERDOSE (Less than a full dose was received by the patient.). On an unknown date, the patient experienced DEVICE CONNECTION ISSUE (Less than a full dose was received by the patient.). At the time of the report, UNDERDOSE (Less than a full dose was received by the patient.) and DEVICE CONNECTION ISSUE (Less than a full dose was received by the patient.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    No treatment information and concomitant medications were provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.
blood pressure and pulse went very high, felt heart palpitations, chest pains on left side of chest, left arm and hand went numb
Received vaccine Saturday morning. Had normal symptoms Saturday night/Sunday morning (headache, body aches, sore arm), then felt normal by Sunday afternoon. Then on Tuesday afternoon, I started feeling  off and on sharp stinging pain in my right arm at the injection site.
AST and ALT check one month after vaccination abnormal. A full workup the elevated results didn't disclose the cause. I also had elevated ferritin level. Ultrasounds were normal. Liver biopsy not done but I have and appointment April 19. The presumptive diagnosed is autoimmune hepatitis. Initial AST 144IU/L and ALT 185 IU/L Values peak on FEB 23, 2023, AT AST 341.  ALT peak on January 25 at 482.Most recent April 3 AST 293 ALT 373.
This case was reporting by a healthcare professional and described the occurrence of swelling in a subject of unspecified age and gender who was vaccinated with TWINRIX, GlaxoSmithKine.  On an unspecified date the subject received an unspecified dose of TWINRIX (unknown).  At an unspecified time after vaccination with TWINRIX, the subject experienced swelling.  At the time of reporting the outcome of the event was unspecified.
pain in lower left lung under breast. hurt to breathe, prescribed steroids and pain patch.  was told no sign of clot, possible pleurisy.
Red Spot on injection site; Her arm was very sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Her arm was very sore) and VACCINATION SITE ERYTHEMA (Red Spot on injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 012M20A) for COVID-19 vaccination.     No medical history was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Her arm was very sore). On 12-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red Spot on injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Her arm was very sore) and VACCINATION SITE ERYTHEMA (Red Spot on injection site) had resolved.            Concomitant medication use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow-up information to be processed at the same time as initial report. Follow-up from the patient indicated they are doing fine. Outcome of events updated.
The patient started experiencing swelling, redness, heat, itching, and pain in the injection site a few hours after administration and she felt like she couldn't move her arm.  The next morning it was still red and painful but the selling appears to be less severe or just better distributed.  Upon awaking on the morning of the third day (10/22/20) the redness has spread farther down her arm.
Patient started having a rash on bilateral arms. He states that "this same thing happened last time, my doctor advised me to get the second shot but to take Benadryl after. I did bring my own Benadryl."  Patient went to his car to take his own Benadryl and came back in for the observation time. During that time his rash started to become less red and he was advised to wait an extra 30 minutes for observation but states "I will be fine, this same thing happened last time. I'm going to go ahead and go."
Information has been received from a consumer referring to her 14 year old daughter no pertinent medical history. The patient was allergic to mushrooms and coconuts. The patient was not pregnant. The patient was vaccinated with all three doses of GARDASIL or GARDASIL 9 (not confirmed the vaccine by the reporter) (both lot number, expiration date, dose and route were unknown) in July 2014, October 2014 and January 2015 respectively. There were no concomitant medications. On an unknown date the patient had stomach pain, headache, fatigue and a loss of appetite after receiving the vaccine. The reporter also reported that on an unknown date the patient spent a week in a hospital due to unspecified event. The outcome of the events was reported as not recovered/not resolved. The causality between the events and GARDASIL or GARDASIL 9 were unknown. Additional information is not expected because the reporter did not consent to contact the physician.
I would like to know why the vaccines are not working against covid-19, my wife, 2 daughters and I have followed the recommendations and we vaccinated and even so we contracted the virus; I would like to know why the vaccines are not working against covid-19, my wife, 2 daughters and I have followed the recommendations and we vaccinated and even so we contracted the virus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I would like to know why the vaccines are not working against covid-19, my wife, 2 daughters and I have followed the recommendations and we vaccinated and even so we contracted the virus".  Clinical course: The reporter stated they would like to know what happens since it begins to lose confidence in the brand and although they do not have an active social life and we take great care of ourselves, they do not understand vulnerability. it's disappointing and frustrating to go on for years at this time. Where is the 95% of protection.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200015090 same reporter/event/drug, different patient.
Mod - to-severe -Fever 101.9 degree F - fatigue - chills - headache - nausea - body aches -Rarm soreness ( inj.site) *started 8 hrs p injectin and stopped ~24 hrs later *took tyLenol and IBp
Patient presented with chest pain and was ruled out for COVID. had CT  chest: IMPRESSION:  1. Bilateral pulmonary emboli.  2. Normal heart ratio.  3. Bilateral lower lobe atelectasis and possible developing  pulmonary infarcts.  4. Bilateral calcified axillary lymph nodes.    PROCEDURE INFORMATION:  Exam: CTA Chest With Contrast  Exam date and time: 1/27/2022 3:06 PM  Age: 39 years old     TECHNIQUE:  Imaging protocol: Computed tomographic angiography of the  chest with contrast.  3D rendering (Not supervised by radiologist): MIP and/or 3D  reconstructed images were created by the technologist.  Radiation optimization: All CT scans at this facility use  at least one of these dose optimization techniques:  automated exposure control; mA and/or kV adjustment per  patient size (includes targeted exams where dose is matched  to clinical indication); or iterative reconstruction.  Contrast material: OMNI350; Contrast volume: 100 ml;  Contrast route: INTRAVENOUS (IV);     COMPARISON:  No relevant prior studies available.    FINDINGS:  Pulmonary arteries: Left lower lobe pulmonary emboli  present. Right upper lobe segmental pulmonary emboli.  Segmental pulmonary emboli in the right lower lobe.  Aorta: Unremarkable. No aortic aneurysm. No aortic  dissection.    Lungs: Bilateral lower lobe atelectasis. Mild airspace  disease and minimal consolidation right lung base.  Pleural spaces: Small right pleural effusion.  Heart: Unremarkable. No cardiomegaly. No pericardial  effusion.  Heart RV/LV ratio: RV/LV ratio 0.7.  Lymph nodes: Bilateral axillary calcified lymph nodes.  Right calcified axillary lymph node measures 22 mm.
Pfizer / BioNTech: 07Oct2021; Paxlovid: Treatment of COVID-19; Pfizer / BioNTech: 07Oct2021; Paxlovid: Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 07Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 33 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Gluten sensitivity" (unspecified if ongoing). Date of last menstrual period: 31Mar2022. The patient is expected to deliver a baby(s) on 05Jan2023. Concomitant medication(s) included: PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]; LEXAPRO. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "recovering" and all described as "Pfizer / BioNTech: 07Oct2021; Paxlovid: Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient had other medication in 2 weeks of vaccination. The patient had Covid-19 treatment from 30Apr2022 to 04May2022. The patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
12 year old patient received 1st dose of COVID19 vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Apr-2021 and was forwarded to Moderna on 12-Apr-2021.    This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old patient received 1st dose of COVID19 vaccine) in a 12-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Reporter details not available).    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old patient received 1st dose of COVID19 vaccine). On 12-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old patient received 1st dose of COVID19 vaccine) had resolved. Not Provided      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.   Nurse accidentally administered the Moderna vaccine in a 12 year old patient. Safety can follow up with the nurse. Concomitant medications were not reported. Treatment details not provided   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Added VAER -  Patient demographics was added (race), Product details: Patient route of administration and anatomical location was added
Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who was administered dose of GARDASIL (dose and route not reported) on 02-JUL-2013, lot # H010915 expiration date: 13-FEB-2013. No adverse event was reported. This is one of the report from the same source. Additional information is not expected.
No adverse event; temperature excursion; This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.      On 29-DEC-2020, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, indication, dose, route, frequency, and anatomical location were not provided) lot # T032003 with expiration date of 08-MAY-2022 for prophylaxis. The vaccines were exposed to a temperature below 2 C for 24 minutes. Data logger was used (product storage error).   Lot number T02003 is an invalid lot number for pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). Lot number T02003 does not match any company product as confirmed by Lot verification team.   combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T032003; expirationdate: 08-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Information has been received from a physician and a registered nurse concerning a 15-year-old white female, with no drug allergies and a history of ureteric vesicle reflux, hydronephrosis, chronic pyelonephritis, and ureteric re-implantation who on 22-AUG-2005 was in the left arm vaccinated with the first dose of varicella virus vaccine live (Lot # 648082/0216R). There was no concomitant therapy. The physician reported that on 01-SEP-2005, the patient developed 20-24 chickenpox with fever. On 15-SEP-2005, the patient presented to the physician's office with many lesions and was reported to be uncomfortable. Treatment was unknown and no laboratory/diagnostic tests were performed. subsequently, the patient's chickenpox resolved. Additional information is not expected.