chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had the shots, still got shingles\ suspected vaccination failure; shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles shots and still got the shingles, but they were not severe. The patient stated, if he/she did not get the Shingles shot, they would have been worse. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
This spontaneous prospective pregnancy report as received from a consumer's boyfriend refers to a female patient of unknown age. Pertinent medical history, drug reactions or allergies were not reported. On 18-NOV-2014 the patient was vaccinated with GARDASIL (dose, dose number, schedule, route, anatomical location, lot number and expiration date were unspecified). No concomitant therapies were reported. On an unknown date in 2014, shortly after receiving the GARDASIL vaccine, the patient became pregnant with last menstrual period (LMP) of an unknown date in 2014 (first trimester of exposure). The pregnancy outcome was pending. The outcome of the event was unknown. Additional information is not expected because no reporter details were provided.
report of local reactions (hot, swollen) in 2-3 dozen children over a 3-4 month period.  nurse reports that the vax had particles which do not fully resuspend.
Pt developed urticaria 4 days after the immunization. Seen at UC on 12/10/21 and then at ER on 12/11/21. Treated with PO benadryl and urticaria resolved a few days after ER visit.
numbness and tingling. Started in my legs and increasingly spread up to my chest, The numbness remains in my hands to this day
Information has been received from a registered nurse refers to unknown number of patients of unknown age and gender. The nurse reported that on unspecified dates, an unknown number of unspecified patients were inadvertently administered PNEUMOVAX 23 (lot#, route and dose unknown) which had been improperly stored. No adverse effects reported. There was no concomitant medication and no pertinent medical history reported. The outcome and action taken were not provided. This is one of several reports from the same source. Additional information is not expected since reporter did not allow to follow up.
Irritability and fever. Temp max 103.8 at 36 hours after vaccination. No vomiting. He did have irritability with (apisthofaniz?) posturing with cry. No loss of consciousness. No trunk convulsion noted.
products were not good and needed to be returned with no reported adverse event; excursion vaccine was administered were within 2, 4, and 6 months of age with no adverse event; Initial information was received on 19-Apr-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves Infant and unknown gender patient who involved in the products haemophilus type B (HIB) (PRP/T) vaccine [ACT-HIB] were not good and needed to be returned and excursion vaccine was administered were within 2, 4, and 6 months of age with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received 0.5 ml of total (1X) suspect hib (prp/t) vaccine Powder and solvent for solution for injection (lot number: UJ756AAA , Expiry date: 12-Aug-2023) (strength: Unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization) were not good and needed to be returned with no reported adverse event (product storage error) (unknown latency) and was administered were within 2, 4, and 6 months of age with no adverse event (poor quality product administered) (latency: same day).  No lab data reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event excursion vaccine was administered were within 2, 4, and 6 months of age with no adverse event and was Unknown for the event products were not good and needed to be returned with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
Information has been received from a healthcare worker referring to 12 patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provide. On unknown dates the patients were vaccinated with M-M-R II (lot # L026551, expiration date 16-JUL-2017, dose, dose # and route unknown) which were improperly stored. The vaccines were stored under 48 F for 1 hour and had been back in range. The vaccines were not out of range before. No adverse event reported. This is one of several reports from the same source. Additional l information has been requested.
the patient who received a vaccine which was more than 25 days in the refrigerator; the patient who received a vaccine which was more than 25 days in the refrigerator; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (the patient who received a vaccine which was more than 25 days in the refrigerator) and PRODUCT STORAGE ERROR (the patient who received a vaccine which was more than 25 days in the refrigerator) in a 27-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 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (the patient who received a vaccine which was more than 25 days in the refrigerator) and PRODUCT STORAGE ERROR (the patient who received a vaccine which was more than 25 days in the refrigerator). On 28-Jul-2021, EXPIRED PRODUCT ADMINISTERED (the patient who received a vaccine which was more than 25 days in the refrigerator) and PRODUCT STORAGE ERROR (the patient who received a vaccine which was more than 25 days in the refrigerator) 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 information was provided by the reporter.  No treatment information was provided.
Felt worse than the flu; This case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was unknown.   It was unknown if the reporter considered the feeling bad to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details provided were as follows: The case was reported by the patient himself/herself. Age at vaccination was not reported. The patient got the shots and felt worse. Follow-up would not be possible as no contact details available. The case was linked by case US2021AMR190585, reported by same reporter. GSK note- case kept valid considering the patient had received Flu vaccine and felt badd after it too.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR190585:Same reporter
incorrectly mixed SHINGRIX which was administered; incorrectly mixed SHINGRIX which was administered; This case was reported by a other health professional via other manufacturer and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the medical assistant incorrectly mixed Shingrix which was administered to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter wanted to know if it needed to be re-administered. No additional information reported. This case has been linked to US2021261507, reported by the same reporter. The reporter denied consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021261507:same reporter
This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions and allergies were not reported. On an unknown date, the patients were vaccinated with doses of GARDASIL 9 (lot # L013429 with expiration date 21-JUL-2017 and lot # K026246 with expiration date 28-JAN-2017), (strength, dose, frequency, route and anatomical location were not reported), which were improperly stored. No adverse events were reported. Additional information is not expected as the reporter did not consent for further follow up.
Pain in left arm, body aches:  took pain meds 2x on Sunday, improved with meds.  Minimal body aches Monday morning, improved with meds
a cold that is in her chest; feels as if she has caught the flu; very fatigue; chills; headache; dry throat (feeling as if something is stuck in her throat); dry throat (feeling as if something is stuck in her throat); runny nose; cough; This is a spontaneous report from a contactable consumer (patient).  A female patient of an unspecified age (reported as 60 no unit reported) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date were unknown), via an unspecified route of administration on 22Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that ever since she received the vaccine, she felt as if she has caught the flu. She experienced symptoms such as chills, headache, dry throat (feeling as if something is stuck in her throat), a cold that is in her chest, runny nose, cough, and very fatigue. She stated that she has been taking cold medicine, but it doesn't seem to be working. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
PATIENT STATED THAT HE WAS  ABOUT TO PASS OUT AFTER RECEIVING JANSSEN COVID  19 VACCINE IN HIS LEFT ARM.  PATIENT WAS LAID  ON THE FLOOR AND EMS WAS CONTACTED. PATIENT  STATED THAT HIS  LEFT LEG WAS FEELING KIND OF NUMB AND HE WANTED  WATER TO DRINK. PATIENT WAS GIVEN WATER . EMS ARRIVED AND CHECKED ON HIM.
The first night it began hurting (as expected), and I woke early, unable to sleep due to the pain in my shoulder.  I took 2 ibuprofen and was able to sleep a few more hours.  The pain did improve in the next couple of days, but it has not gotten better since and actually is more limited 9 days post injection than over the weekend.  (Ibuprofen and heat helps temporarily, but it continues to return.) By 5/27/2014, functional range of motion is limited to approximately 80-90 degrees of flexion and abduction, and daily activities are painful or very difficult including such things as brushing/washing hair, doing laundry, reaching for items on cupboard shelves, turning off alarm clock, etc.  Saw nurse practitioner on 5/28/2014, x-rays and exam performed--diagnosed with allergic reaction-frozen shoulder and referred to orthopedic doctor for next-day appointment on 5/29/2014.
Patient is a 55 y.o. female presenting from home with complaint of shortness of breath. Patient tested positive for COVID-19 infection in January 15. Last 2 days started to get sob with mild cough, no phlegm production Denies chest pain Initially had fever, but no fever last 3 days In ED, dropped sat to 89% momentarily, but was found to be tachycardic 130 range sinus CT PE was negative for PE, showed Mild infiltrative changes of the left lower lobe and lingula.  Likely related to patient's known atypical infectious process.  No superimposed dense airspace consolidation Pt has been treated with Remdesivir, Decadron and supportive care. Pt has been stable in room air. Pt wants to go home today. She will receive the fourth dose of Remdesivir. Then she is OK to be discharged home. She will follow up with primary care physician Pt reported dysuria. Her UA showed positive nitrite. One dose of Cipro 500 mg given (pt is allergy to Amoxicillin). She will continue take Cipro 500 mg twice a day for 7 days for UTI.
Possible headache; Arm of injection swollen; Heartbeat; Fatigue; A spontaneous report was received from a consumer concerning a 42-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache, peripheral swelling, heart rate increased, and fatigue.  The patient's medical history, was not provided. No Concomitant medications were reported .  On 20 Jan 2021,wednesday, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 030620A) via unknown route in the left arm for prophylaxis of COVID-19 infection. On 27 Jan 2021 morning, patient experienced swelling on his left shoulder. Also patient reported that he experienced headache ,heartbeat and fatigue after the vaccination.  The treatment for the events was reported as Tylenol 2.  Action taken with mRNA-1273 in response to the events was unknown.  All the events were reported as resolving.; Reporter'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. Further information has been requested
This spontaneous report was received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot# M032635 and expiry date 05-MAY-2018) intramuscularly. No adverse effects were reported. The administered vaccine was exposed to temperature excursion of 32.7 Fahrenheit for 2 hours and 15 minutes and 33.1 Fahrenheit for 4 hours. No previous temperature excursion were reported. Data digital logger was involved. No product quality complaint (PQC) was filed. This case is one of several reports received from the same reporter. Additional information has been requested.{Additional information has been requested. / Additional information is not expected.}
Patient took dose 1 on 31-Mar-2021 and dose 2 on 10-Apr-2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took dose 1 on 31-Mar-2021 and dose 2 on 10-Apr-2021) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Food intolerance NOS (Have food in tolerants. Reaction: allergy).   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took dose 1 on 31-Mar-2021 and dose 2 on 10-Apr-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took dose 1 on 31-Mar-2021 and dose 2 on 10-Apr-2021) outcome was unknown.            The patient was not taking any other medications within 2 weeks of COVID-19 treatment. No concomitant medications were reported. No treatment information was reported.   This case was linked to MOD-2022-580228 (Patient Link).
This spontaneous report was received from a nurse practitioner and refers to a 16 week old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, at the age of 16 weeks, the patient was vaccinated with ROTATEQ vial, dose one, lot number N022001 with expiration date on 03-FEB-2019, orally for prophylaxis (strength was not reported). No adverse effects reported.
Tingling in earlobe; numbed jawline; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 26Mar2021 at 09:00 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications included paracetamol (TYLENOL) and meloxicam (MANUFACTURER UNKNOWN), both taken for unknown indications from unknown dates. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Mar2021 at 09:30, the patient experienced tingling in earlobe and then numbed jawline. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcomes of the events tingling in earlobe and then numbed jawline were recovered on an unknown date.   No follow-up attempts are needed. No further information is expected.
Moderate to severe pain in left arm at shot area that radiates to shoulder and down arm. Tylenol taken no relief. Ice and medicated cream applied almost 3 weeks latter pain is still here.
This spontaneous report as received from a immunization official refers to an unknown number of patients of unknown age and gender. Medical history was not reported. On an unknown date the patient was vaccinated with RECOMBIVAX HB injection (lot# not provided) route, dosage and frequency were not reported. Concomitant therapy was not reported. The reporter informed that on an unknown date the patients may have received RECOMBIVAX HB that was improperly stored from 11-JUN-2013 to 22-APR-2014. No adverse effects were reported. This is one of several reports received from the same reporter MARRS case #1405USA003763, #1405USA004445 and #1405USA004446. Additional information has been requested.
The patient is a 89y.o. female who presented on 12/9/2021 complaining of chest congestion and body aches. She had a history of dementia, HTN, A fib, COPD, hodgkin lymphoma, IBS and thyroid disease and  Was having cough and body aches for the past few days and they did a at home COVID test that was found to be positive. She was also having some sputum production, fatigue, generalized weakness and decreased appetite. She was also having some SOB. She was afebrile, normotensive and hypoxic on RA. BNP was within normal limits for age. She was COVID positive in ED. CRP and inflammatory markers were elevated on admission. She was started on IV steroids and ID and pulmonology were consulted. Pro calcitonin was within normal limits. On 12/11 she had marked deterioration in her condition compared to day prior and was on HFNC 60L as well as non rebreather she was having some bloody sputum and hematuria as well. She was treated for possibly superimposed bacterial pneumonia She did get monoclonal antibody treatment day prior and tolerated it without issues. She was continued on steroids and antibiotic. She continued to have increasing oxygen requirements and family ultiamtely decided to withdrawal care and proceed with comfort measures. Patient was transitioned to NC from non rebreather and HFNC and comfort medications were ordered other medications were stopped. STAT hospice consult and SW consult were placed by service. Patient ultimately passed 12/14 at 03:40 am. I was contacted by the medicine resident
The morning after the injection: I woke up with a very sore swelled arm that lasted several days; each day less soreness.   I felt very fatigued and feverish for the first day at least. About 2 days after the injection,  I had a stomach disorder.  I had stopped at a restaurant after the injection.  Don't know if the stomach problem is connected to the vaccination or eating out. I did not feel well for 3-4 days, which is very unusual for me. I have had a flu shot annually for probably 30 years, and have never had a reaction other than one instance of very slight soreness at the injection site.
presented w/vesicular lesions 5mo p/vax;varicella zoster IGM 0.20;IGG 0.81 antibody negative;