chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had the shot after years I got shingles/suspected vaccination failure; shingles; burning; pain is horrible.; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In February 2023, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, burning sensation and pain. The patient was treated with non-drug therapy (Ice Pack (No Medication)) and medication unknown (Pill (Medication Unknown)). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, burning sensation and pain were recovering/resolving.   It was unknown if the reporter considered the vaccination failure, shingles, burning sensation and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 03-MAR-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received the shot 4 years prior to the reporting.  The patient had shingles a week prior to the reporting the burning and pain was horrible.  The patient used Ice packs for help.  The physician gave two kind of pills and which had helped a little.  The physician said it would be a week or more of this. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
In bed all day; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (In bed all day), CHILLS (Chills) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (In bed all day), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, VACCINATION COMPLICATION (In bed all day), CHILLS (Chills) and PYREXIA (Fever) was resolving.            Concomitant medication list was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-032870 (E2B Linked Report).; Sender's Comments:  MOD-2021-032870:First dose case
Painful at site. Swelling at site. (Warm to touch). Hoarse voice slight fever TYLENOL.
Approximately 11 days post vax, the pt developed a moderate fever, a diffuse maculopapular rash and hepatocellular destruction. The pt was hospitalized and worked up. The rash gradually faded over a two day hospitalization and the pt never quite met the diagnostic criteria for Kawasaki disease which the reporting physician considered for a time. The pt's experience has since resolved and the reporting physician is contemplating giving the pt the second dose of MMR vax.
Face got red on trip home. Developed hives and erythema to abdomen during a nap immediately after vaccines. Gave 3rd BENADRYL in office, advised to give every 6 hours for 24 hours and CLARITIN 2.5 ml a d x 5 days.
Vaccine was administered from a vial that was left out of the fridge for over 12 hours after being punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered from a vial that was left out of the fridge for over 12 hours after being punctured) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered from a vial that was left out of the fridge for over 12 hours after being punctured). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered from a vial that was left out of the fridge for over 12 hours after being punctured) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported  No treatment medication were reported   Most recent FOLLOW-UP information incorporated above includes: On 24-Aug-2021: Follow-up received included No New Information
Patient stated his arm began to feel sore shortly after receiving the vaccine and he has had pain and limited mobility since the injection.  Adverse event was reported to pharmacy on November 9th, 2010.
11/14 pm-welts on legs-itchy-resolved in 24 hours.  11/15 swollen lower lip.
Redness of right eye and left eye which was diagnosed as episcleritis; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269) via an unspecified route of administration on 16Mar2021 (at the age of 17-years-old) and also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration on 06Apr2021 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history included uveitis, migraines and depression. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included adalimumab (HUMIRA), methotrexate (MANUFACTURER UNKNOWN), escitalopram (MANUFACTURER UNKNOWN) and folic acid (MANUFACTURER UNKNOWN), all taken for unknown indication from an unknown date and unknown if ongoing. On 22Mar2021, about 6 days after the first dose of COVID-19 vaccine, the patient noticed redness of right eye which was diagnosed as episcleritis and started eye drops with mild improvement. On15Apr2021, about nine days after the second dose of COVID-19 vaccine, the patient noticed redness of left eye episcleritis which was improving with steroid drops. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included treatment with loteprednol (MANUFACTURER UNKNOWN) eye drops and artificial tears. The clinical outcome of the event redness of right eye and left eye which was diagnosed as episcleritis was resolving at this time of this report.   No follow-up attempts are needed. No further information is expected.
TROUBLE BREATHING; DIZZINESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced trouble breathing. On 24-MAR-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from trouble breathing, and dizziness. This report was non-serious.
I had a headache and sore arm when I left the office. My arm started to hurt more during the evening and then about 7 hours after the injection I got extreme chills, indigestion/loss of appetite and was  unable to lift my arm all the way or move it laterally, then fever, muscle aches and weakness. The pain in my arm, weakness and loss of appetite lasted for 4 days.
Client was monitored 15 minutes post-vaccination.  Tolerates without difficulty.  Client leaves with  mother and returns approximately 15  minutes later.  Mother enters the clinic and states that her daughter cannot walk.  Nurse assesses client in car.  Client denies shortness of breath, dizziness.  States that both legs hurt terribly and she can barely walk.  Legs warm to touch.  Client was able to move them but was in tears.  Encouraged mother to take client to emergency room to have her assessed.
diagnosed/reactive arthritis: joint pain, swelling & stiffness in hands & knees;taking high doses of advil;
Information has been received from a healthcare worker concerning a 14 year old male who on 05-AUG-1996 was vaccinated with MMR II, and was diagnosed with rheumatoid arthritis. The vaccination of MMR II was not given by this facility. The patient had a problem as a child (specific dates unknown or time period). The patient had seen an unspecified rheumatologist. The patient was currently taking methotrexate 6 times a week and RITUXAN every 6-9 months (last dose was DEC-2008) for rheumatoid arthritis. At the time of report, the patient had not recovered. No further information is available.
the patient experienced tongue swelling 9 hours after injection; This is a spontaneous report from a contactable physician (patient).  A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on Arm Left from 28Dec2020 12:45 to 28Dec2020 12:45 as single dose for COVID-19 immunization.  Medical history included allergy to Latex and depression.  Concomitant medication included duloxetine hydrochloride (CYMBALTA).  The patient previously took Percocet and experienced allergies. On 28Dec2020 at 09:45 PM, the patient experienced tongue swelling 9 hours after injection. The patient stated had this similar feeling or reaction after taking Percocet when she had her first child. The patient took Benadryl 25mg as treatment to the event. The outcome of the event was recovered.  Information about lot/batch number has been requested.
itchy spot around injection site; large red rash; Size of apple or tennis ball swollen; Red rash; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), VACCINATION SITE PRURITUS (itchy spot around injection site), VACCINATION SITE RASH (large red rash), VACCINATION SITE SWELLING (Size of apple or tennis ball swollen) and VACCINATION SITE ERYTHEMA (Red rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 21-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itchy spot around injection site), VACCINATION SITE RASH (large red rash), VACCINATION SITE SWELLING (Size of apple or tennis ball swollen) and VACCINATION SITE ERYTHEMA (Red rash). At the time of the report, PAIN IN EXTREMITY (sore arm), VACCINATION SITE PRURITUS (itchy spot around injection site), VACCINATION SITE RASH (large red rash), VACCINATION SITE SWELLING (Size of apple or tennis ball swollen) and VACCINATION SITE ERYTHEMA (Red rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Chronic headache  (frontal lobe) (forehead, eyebrow area, temples)
Localized erythema/swelling of injection site almost immediately after admin (L arm IM). Treating with ice and ibuprofen. No s/sx anaphylaxis.
2-3d p/ vax, dx w/ear infect;4d p/vax, vomiting & febrile w/ T102.6,tx w/ APAP; 11/21/98-child "died" and was resuscitated; currently comatose; MD has stopped all vaxs
R09.02 HYPOXIA 8/22/2022 HYPOKALEMIA R09.02 HYPOXIA 8/22/2022 CANCER METASTATIC TO BONE    DM 2 WO COMPLICATIONS R09.02 HYPOXIA 8/22/2022 PERICARDIAL EFFUSION R09.02 HYPOXIA 8/22/2022 ASTHMA, UNSPECIFIED R09.02 HYPOXIA 8/22/2022 HYPOKALEMIA
Patient developed hives, fatigue, swelling and black and blue discoloration at site of Tdap injection.
This initial spontaneous report was received from a physician referring to a 4 month-old female infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 15-SEP-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Called to see pt in drive up lane 4 min post vaccination. She immediately felt after the vaccination, numbness and tingling of face, tongue, throat.   Past med history of rheumatoid arthritis and HTN. Possible allergy to Benadryl and Demoral.  Initial examination lungs CTA, regular tachycardia. Swelling of lips, and tongue, uvula midplane, not deviated. Pt moved to observation area.  Initial vitals:   BP: 185/87, HR 128, RR 20, 100% O2 at 10:25  EMS notified and first injection 3mg Epi pen injection given at 10:23am;   911 called. BP: 185/87, HR 128, RR 20, 100% O2 at 10:25. Second epinephrine 3mg injection given at 10:26am. BP 185/87, HR 134, O2 sat 100% at 10:29am. Benadryl 50 mg po given at 10:29am. Next dose of epi given at 10:34 failed, 4th dose given at 10:35am. EMS arrived and she was taken to hospital at 10:45.
EMS CALLED PATIENT SHORT OF BREATH, TO ER IN CARDIAC ARREST, HAD EXTENSIVE EFFORTS TO RESUSCITATE AND HAD SECOND CARDIAC ARREST BUT PATIENT UNABLE TO BE RESUSCITATED.
Body aches, chills, headache, fatigue, loss of appetite for approximately 24 hours after onset.
Thyroiditis sabacute; I had a menstrual period that lasted for over 2 weeks; This is a spontaneous report from contactable other health professional (patient). A 27-year-old non pregnant female patient reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch number/Lot number: EW0177), via an unspecified route of administration, administered in left arm on 01Jul2021 at 04:45 PM (age at vaccination was 27 years) as dose 1, single for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Vaccination facility was pharmacy or drug store. Medical history and concomitant medications were not reported. No known allergies reported. The patient did not receive other vaccine in four weeks and did not receive other medications in two weeks. After getting the first vaccination, on 05Jul2021 at 08:00 AM, the patient experienced subacute thyroiditis, as per Endocrinologist and also had a menstrual period that lasted for over 2 weeks, despite having a normal cycle the week prior to taking the vaccine. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for adverse events. No covid prior vaccination and not tested covid post vaccination. Outcome of the events was recovered/resolved with sequel.
Patient had severe headache, fever (didn't measure how high), diarrhea, and chills. She stated the began on 10/18/18 and lasted for about 24 hours. When patient was contacted on 10/19/18 she stated she was doing much better.
Heart palpitations, burning in urinary track, ringing in ear, lose of smell/taste, blurry vision, headache,  metal taste in mouth,   Experincing every Covid symptoms but testing negative for COVID 19
Lip swelling that started approximately 24 hours after vaccine. Self resolved. No hives, wheezing, vomiting, or other symptoms. The swelling improved over the course of the day but returned the following morning and then resolved again.
Nickel-sized raised lump around injection site. Patient reports site is very itchy; patient denies any pain.
Pt recvd DTP/OPV 25FEB92; fever started few hrs later 105 ax;
102.2 Fever brought down with Tylenol, also had otitis media diagnosis (No fever at time of administration of vaccines)
Initial information received from a healthcare professional on 24 August 2012. A 02-year-old female patient whose medical history and concomitant drugs were unknown; had received an intramuscular injection (dose 4) of DAPTACEL (lot number C4127AA) in the right deltoid on 28 August 2012. The patient also received Varicella vaccine (manufacturer unknown, lot number, route and site of administration were not reported) on 28 August 2012. On 29 August 2012 i.e. one day post vaccination, the patient developed redness, swelling and hotness at injection site. The size was 5 cm by 3 cm. Laboratory details and corrective treatment were not reported. The patient's outcome was unknown. Follow-up information was received 26 October 2012 from a health care professional. Based upon new information received, it was determined this case now meets seriousness criteria and has been upgraded from nonserious to serious. The patient had no significant past medical history and no illness at the time of vaccination. On 29 August 2012, the patient was examined by their physician and the right shoulder of their arm was slightly tender with a 3cm round area with a 2cm induration area in the middle. Temperature was 99.8. The patient received oral KEFLEX 200 mg tid for ten days as treatment for possible cellulitis and the patient's arm improved within 24 hours. Laboratory and diagnostic testing was not performed. At the time of the report, the reporter stated the patient had returned to their usual state of good health and had recovered (date of recovery not reported). Documents held by sender: None.
a couple of days after getting the vaccine i developed heart palpitations, tachicardia , some chest pain. The chest pain and some difficulty breathing persisted for a few days and i went to see my PCP.  i had pain in my shoulders weakness.  My doctor told me I was fine.  My palpitations continued for the next several months. I am now also having heahaches, pains all body. I am always tired and weak. I started to experience some brain fog.
This spontaneous report as received from a licensed nurse practitioner refers to 10 unspecified co-workers. Medical history was not provided. On 25-JUL-2013 the patients were vaccinated with ZOSTAVAX (lot number not provided). Concomitant medication was not provided. On an unknown date in 2013 after the vaccination, the patients experienced the exact same reaction as the reporter (see linked case 1307USA002302) which were reported as: cellulitis at the injection site, felt crappy overall, had achy joints, were feverish and had local reaction. The nurse reported that ZOSTAVAX was pre-drawn into a plastic syringe that might had left out for more than 30 minutes. The outcome of the events was not reported. Additional information has been requested.
Invalid dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Oct-2021 and was forwarded to Moderna on 05-Oct-2021.    This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Invalid dose) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: INFLUENZA VACCINE (Lot number 323626) on 27-Sep-2021.   On 04-Oct-2021 at 8:35 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Invalid dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Invalid dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment medications reported. The invalid dose of Moderna was pulled out of the freezer on Friday October 1st, 2021. The invalid dose of Moderna expired on Sunday October 3, 2021. The Invalid dose of Moderna was administered on Monday October 4, 2021 at 0835 in the morning into this patient's left arm.   Most recent FOLLOW-UP information incorporated above includes: On 07-Oct-2021: Follow up received: Added new reporter, historical vaccine Influenza AIIV4 added, patient route of administration Intramuscular added.
Soreness in arm at injection site at time of injection and for several days after; fever, flu-like aches, weakness about 12 hours after injection which lasted for 1 or 2 days. Also upset stomach but may not be associated with vaccine.
Patient reported a welt, upper arm swelling, redness and itching at the site of injection. Patient stated this started a couple days after vaccination and resolved without any intervention in  approximately 7 days. She did not report adverse event until after it had resolved.
Received Dtap, IPV, MMR, Varivax on 05/05/10. C/o leg pain 05/06/10 pm. Left thigh very red, warm, firm, and painful.  Induration 10.1x10.6 cm.  Pt received IPV and Varivax inj. in that leg.
Employee came in for testing at community due to general exposure that evening was feeling ill, cold symptom, fever
Pt received Pneumovax 23 during hospital admission. Leucocytoclastic vasculitis developed after injection. Generalized erythematous nodules and papules were seen.
Patient recieved five vaccines at time of visit. After receiving her vaccines she stated that she felt weak and then she fainted. The patient had not eaten. After the patient came to, she was given juice and pretzels. We kept her until she was feeling better and regained color in her face.
to ED c/o weakness and exposure to COVID via wife; CXR negative pneumonia and not hypoxic so no covid specific therapies initiated; d/c'd home
p/ pt recv vax approx 2yrs later exp greater than 50 lesions, headache, slight temp & very itchy. f/u MD indicated 6/30 pt exp 50-75 chickenpox over body
ON 10/9, WENT TO HOSPITAL ER C/O LEG PAIN, SEVERE MID BACK PAIN RADIATING TO BILATERAL THIGHS, ASSOCIATED WITH WEAKNESS & SENSORY LOSS. LEGS KEEP GIVING OUT ON HER AND THE SENSATION T OHER UPPER THIGHS IS DIFFERENT. URGE TO URINATE BUT CANNOT. UNABLE TO WALK
Attendee vocalized feeling sweaty, clammy, pale, self resolved with lying down for 15 minutes. No further needs