chrisvoncsefalvay/vaers-outcomes huggingface dataset:
15 mins after vaccine administration he c/o itchy throat, itching around his neck and feeling dizzy. Initially felt mildly nauseous but it subsided, no vomiting. He denies dyspnea. O: BP: 115/60, HR 88, SaO2 100%, RR 16, T: 98.6.
May 11th 2007 (4 month vac) several days later he got a terrible rash- It was splotchy and several areas of his body. Applied Hydrocortizone cream continuously for approximately 2 months, helped the rash, but didn't prevent it from spreading and did not make it go away.   Again on Feb 13th 2008 in for his (12 month vac) we are seeing the same rash.  It is again splotchy and on different areas of his body.  From what I am reading, this may occur with the varicella vaccination, but this is the first dose he's received, so I believe it is a seperate vaccination to be the cause.
Bilateral color change and swelling in lower extremities transient. Lower extremities blood pressure discrepancy relative to upper extremities during episode of swelling.
This case was reported by a physician from a blood center and described the occurrence of HEPATITIS B surface antigen positive in a subject of unspecified age and gender who was vaccinated with HEPATITIS B vaccine, (manufacturer unspecified).  On an unspecified date the subject received unspecified dose of HEPATITIS B vaccine (unknown).  One day after vaccination with HEPATITIS B vaccine, the subject presented to donate blood and when the blood was tested HEPATITIS B surface antigen was found to be positive.  The physician did not have any information regarding the subject.  At the time of reporting the outcome of the event was unspecified.
Per pt noted on 08/10/10 evening, left upper arm swollen, redness & warm to touch. Mild itching but itching resolved by visit time. Pt was in no acute distress, took Tylenol Pm that evening & the next morning prior to visit. He was given Prednisone 50mg x5 days.
After my vaccine shot all my joints, every cut or injury site and every spot I've ever had surgery swelled up. I couldn't move my hands or walk on my feet. This effect lasted for about a week after the vaccine
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Nov2021 at 14:30 as dose 3 (booster), single (Lot number: Ff2539) at the age of 67 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer, Dose Number: 1,2), for Covid-19 immunization. The following information was reported: COVID-19 (medically significant) with onset 21Apr2022, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Apr2022) Negative, notes: I initially felt better and tested negative for Covid 19 on Tuesday 4/19/22; (21Apr2022) Positive, notes: tested positive for Covid 19 Thursday evening 4/21/22. Therapeutic measures were not taken as a result of covid-19. Clinical course: patient initially felt better and tested negative for Covid 19 on Tuesday 19Apr2022. Wednesday 20Apr2022 my symptoms returned and  tested positive for Covid 19. Thursday evening 21Apr22. Patient had not have any known allergy. And no other medication in 2weeks
i dont know if this is adverse or not, but ive lost most of my sense of taste and smell. i can only tell if something is sweet or sour but thats all. maybe not related but i dont know what else it could be. it started about 2 days after my second vaccine.
no adverse event on patient; temperature excursion; This spontaneous report was received from an office manager referring to a 12-year-old male patient. The patient had none pre-existing physician-diagnosed allergies, birth defects and medical conditions. Information of concomitant medications was not reported.  On 28-DEC-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (1 dosage form (1 dose); strength, route and anatomical location were unknown) (there were five possible lot # of the vaccine administered: lot #1775811, expiration date: 07-DEC-2023, lot #1775827, expiration date: 27-JUN-2024, lot #U032681, expiration date: 26-OCT-2023, lot #1780876, expiration date: 09-NOV-2023, and lot #W009829, expiration date: 19-OCT-2024; it was not specified which one was received by the patient) for prophylaxis at private doctor's office/hospital by the ordering physician. The vaccine was purchased with public funds and the vaccine-device was purchased with private funds. The vaccine experienced temperature excursion on 09-SEP-2022 for 8 minutes and on 16-SEP-2022 for 5 minutes (product storage error). Excursions were not noted until after the fact due to employee error of cleaning data logger more than once a day. This medication error occurred in the process of storage in clinical practice. This report was called because of a data logger.  No adverse event and no issues were on patient (no adverse event). The patient had no illness at time of vaccination. The patient did not die.   This was one of several cases received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221
This spontaneous report was received from a nurse practitioner refers to a 55 years old patient who on 22-AUG-2012, was vaccinated subcutaneously with a dose of MMR II subcutaneously (Lot number: 0234AE, expiry date: 26-JAN-2014, Lot number: 1003AA, expiry date: 28-JUN-2013) that was stored at 47 Fahrenheit for 13 hours. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Information has been received from a registered nurse concerning an 11 year old male child with a penicillin allergy and seasonal allergies who on 08-MAY-2007 was vaccinated SC in the back of the left arm with the second 0.5ml dose of varicella virus vaccine live (Oka/Merck) (657192/0362U). It was reported that the patient did not have a reaction with his first dose of varicella virus vaccine live (Oka/Merck). Concomitant vaccine given the same day included in the right deltoid a dose of meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) and in the left deltoid a dose of diphtheria toxoid (+) pertussis acellular 1-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (DTAP-IPV). Concomitant medications include fexofenadine hydrochloride (ALLEGRA), montelukast sodium (MSD) and albuterol. On 09-MAY-2007 the patient experienced redness and swelling at the injection site. On 10-MAY-2007 it was reported via a phone call that the patient's arm was more swollen and the red spot was larger. On 11-MAY-2007 the child was seen in the office at 15:15 pm and the child's arm was tender at the injection site and swollen about 5 inches in diameter with an irregular circle noted. The inner circle was red with a darker red on the outer circle. The child was treated with cephalexin (KEFLEX). The patient's status at the time of the report was not recovered. No product quality complaint was involved. Additional information has been requested. Follow-up information received from a registered nurse stated that the patient received a concomitant intramuscular dose of diphtheria toxoid (+) pertussis acellular 5-component vaccine (+) tetanus toxoid (ADACEL) (Lot # "C2644AA") in the left arm. The lot # for MENACTRA was "U2227AA". On 10-MAY-2007, the patient's left arm (back of arm) became swollen, red, and tender to touch. The patient called the office on 10-MAY-2007 and was advised to come in. The patient was seen on 11-MAY-2007 and diagnosed with cellulitis and place on cephalexin (KEFLEX) 250mg, 1 tablet, three times a day. On 21-MAY-2007, a follow-up call was made to the parent and it was noted that the patient's symptoms had resolved. The patient recovered. There were no diagnostic tests or labs performed. There were no adverse events following prior vaccinations. There was no illness at the time of vaccination.
During 1st Pfizer Booster vaccination of patient, she expressed to me, to not use a bandaid as last time she removed a bandaid from an injection point, she passed out. Patient denied feeling ill at this time, and denied having any side effects from previous Covid vaccinations. Patient was informed of possible side effects, and need to hold for minimum of 15 minutes post vaccination for observation. Patient agreed, and was vaccinated with 0.3ml Comirnaty Pfizer Booster dose into right deltoid while holding her mothers hand. Patient did not appear to be in distress, and had no signs of SOB. No bleeding of at site was observed post vaccination. Immediately after injection, patient laid her head on her mother's shoulder, looked up at her and 2 seconds later, started to stiffen her body leaned back into her vehicles passenger seat, eyes became fully dilated, 2 x mild body jerking motions observed, no breaths taken at time of what appears to be a seizure event that lasted no more than 8 seconds. As the possible seizure was occurring, patients mother reported that her husband (patient's father) has syncope events similar to this during blood work. Patient regained consciousness, took a deep breath, eyes returned to around 3mm. Breathing rate 12 per minute, stating that she was fine. Patient grabbed her water bottle and took sips, only to vomit the fluid out around 15 seconds later. Patient was given paper towels, and leaned her seat back. Patient reported feeling tired from her muscle flexion. Patient failed to inform me that during a previous flu vaccination, she had passed out in similar fashion. Patients mother stated that vasovagal syncope is thought to be the cause of her collapse and seizure activity, but have not completed blood work to determine final diagnosis and treatment. Patient was held for 30 minutes post vaccination (0911 - 0941hrs) for continued observation. Patient did not have any recurring episode and was using her phone for most of the waiting period. Patient reported feeling well, did not require additional medical assistance, and was permitted to depart, on basis of family history, denial of further assistance required, and feeling well after a possible seizure event. BASIC CAUSE/CONTRIBUTING FACTORS: Patient did not mention any known side effects when asked.
This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (>42 days of not receiving second Moderna Covid-19 vaccine dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (>42 days of not receiving second Moderna Covid-19 vaccine dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (>42 days of not receiving second Moderna Covid-19 vaccine dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Employee received flu shot on 10/26/00 and developed chest tightness and slight hoarseness immediately after the injection. Seen in ER with complete resolution of the symptoms and discharged.
12 hours after the vaccine- high fever (101.5), chills, severe body aches, headache, very sore arm (gone in 36 hours) 1 week after the 2nd dose- swollen, painful  lymph nodes (lasted 7-10 days) 4 weeks after the 2nd vaccine- a strange knot developed by my left elbow (cyst-like) slightly larger than pea size (still have it) 6 weeks after 2nd vaccine- posterior right sided neck pain (annoying) 7 weeks after 2nd vaccine- anterior and posterior right sided neck pain (severe)- feels like I have a tumor in my neck (current)
This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Moderna product on 01/03/2021 and 01/31/2021. They tested positive for COVID-19 twice via antigen test on 10/14/2021 at the nursing home at which they were a resident. The individual died on 10/30/2021.  I do not see any indication the individual was hospitalized related to this illness.
Red, swollen - left thigh at 24 hours. 4 cm diam redness, 6 cm diam induration/swelling.
This spontaneous report was received from a other health professional refers to a patient of unknown age and gender. Medical history and concurrent condition were not reported. On 08-MAY-2014, the patient was vaccinated with one dose of GARDASIL (dose, strength, lot number and expiration date were not reported) intramuscular route. Co-suspect and concomitant therapies were not reported. The healthcare worker reports that an improperly stored GARDASIL was administered on 08-MAY-2014. The healthcare worker reports that the GARDASIL, was exposed to a temperature of 34F for 30 minutes on 05-MAY-2014. No adverse effect reported. Additional information has been requested. These case is one (1) of ten (10) reports from the same reporter. (MARRS 1405USA011237, 1405USA013601, 1405USA013602, 1405USA013603, 1405USA013604, 1405USA013605, 1405USA013606, 1405USA013607, 1405USA013608 and 1405USA013609). Additional information has been requested.
Narrative: Patient with a history of atrial fibrillation experienced palpitations night of 1/27/2021 which woke him up and lasted about 30 minutes. He has had afib 15 years and states he never has felt it when it was active. Patient was asked to contact cardiology for discuss and follow-up. Patient returned for second  dose of vaccine 2/8/2021; no adverse event reported with 2nd dose as of 2/11/2021.
No known adverse reaction to receiving this vaccine Patient will have evaluation with pediatrician on 5/23 @ 10:30 am to confirm.
patient presented to emergency department on 10/10/21 with difficulty breathing and cough patient tested positive  and was admitted for further management of covid-19 patient did require treatment for symptoms associated with covid-19 including dexamethasone and remdesivir patient was discharged to rehab facility on 10/19/21
made me sick as hell; Initial information received on 01-Jan-2022 regarding an unsolicited valid Social Media non-serious case.  This case involves a patient of unknown demographics who reported event "made me sick as hell", while receiving vaccine INFLUENZA VACCINE.    The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site as flu vaccine.  On an unknown date the patient developed a non-serious event "made me sick as hell" (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that the "last flu shot I had made me sick as hell. no way no shots, GOD gave me what I need and so far its worked really good., haven't been sick in over 14 years and had NO SHOTS."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (made me sick as hell).  At time of reporting, the outcome was Unknown for the event made me sick as hell.
Initial misuse report received from a healthcare professional on 14 May 2013. It was reported that the patient was administered a dose of MENACTRA on 03 May 2013 and then again on 05 May 2013. No adverse event was reported. Documents held by sender: none.
Information has been received from a medical assistant concerning a 5 year old patient who on an unknown date, was vaccinated with a dose of ZOSTAVAX (Merck). The patient experienced drowsiness and a fever approximately a half hours after vaccination. It was unknown if the patient sought medical attention. At the time of the reporting, the patient's status was unknown. Follow up information has been received from the reporting medical assistant concerning the 5 year old female with no illness at time of vaccination who at 4:15 PM on 12-JUL-2010 was vaccinated subcutaneously with the first dose of ZOSTAVAX (Merck) (lot#665519/1225Y) in arm. Secondary suspect therapy on the same day included the second dose of MMR ll (lot#665874/1335Y) subcutaneously vaccinated in left thigh. Concomitant therapy on the same day included the fifth dose if TRIPEDIA (lot#C3381AA) intramuscularly vaccinated in left thigh. On 12-JUL-2010, the patient experienced fever low grade that night. There was no other complaints or reactions. On 13-JUL-2010, the patient recovered from fever low grade. The patient did not seek medical attention. Additional information has been requested.
Administer expired vaccine to patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 168 doses.  The vial did not undergo any temperature excursions.  Treatment information was not provided.   This case was linked to MOD-2022-581986 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live follow up received included non significant information of secondary reporter was added.
Pt. present for 2nd COVID vaccine Moderna, and requested Pfizer. Contract nurse, RN gave Pfizer for 2nd dose. Pt. remained in clinic for 20 minutes, notified of vaccine error, pt. without adverse effects.
Wrong vaccine given to patient. Provider verbally told nurse to administer pneumovax 23, nurse misunderstood and administered prevnar 13. Nurse did attempt a second check on the vaccine she was giving with another RN however the order was not verified prior to administering by either nurse. Nurse advised leadership, provider, and contacted the patient to let her know what happened. Education was given to both nurses on the proper second check procedure. Education also given to provider to ensure she is given clear verbal orders and to ensure that the order is signed prior to administering. Add: Medwatch submitted 4/12/22
Developed bilat LE weakness, inability to walk 2 weeks after vaccine. Dx: Guillain-Barre Synd.
Swelling and redness at right deltoid muscle. Benadryl 25 mg PO given to patient for treatment.
Injection site soreness, redness and pain. Fatigue and chills. Slight headache.
ATE 15 MIN AFTER THE FOURTH DOSE; This spontaneous case report (PVX2019-1744) report was received from a nurse on 03-Jul-2019. It describes a 67-year-old elderly male consumer who "ate 15 min after the fourth dose" (PT: Product administration error), while being on Vivotif for an unknown indication.  Case report: The consumer took the first three doses of Vivotif correctly, but he ate 15 min after the fourth dose. The first dose was taken on 27-Jun-2019 and the last dose on 03-Jul-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "ate 15 min after the fourth dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "ate 15 min after the fourth dose" was considered as not applicable.
tested positive for covid 19 on 3/22 at hospital.  Admitted for low oxygen and cold like symptoms
PRESENTING WITH A FEVER.  HAD SHINGRIX IMMUNIZATION ON Friday./  ARM SWELLING, ERYTHEMA, PAIN, TENDERNESS.  HAD SYSTEMIC SYMPTOMS OF FEVERS, FATIGUE, DIZZINESS, AND MALAISE.    NO COUGH, CHANGE IN BOWEL OR BLADDER HABITS. NO HEADACHE.
This spontaneous report as received from a physician via company representative refers to a 69 year old male patient. The patient's pertinent medical history and drug allergies were not reported. On 03-FEB-2016, the patient was vaccinated with PNEUMOVAX 23 injection (lot number: I024132) at a dosage of 0.5 ml one time injection. Approximately in February-2016, the patient experienced rash and scabbing on the arm where he received the PNEUMOVAX 23 injection. The patient sought medical attention, contacted physician. The outcome of the events was unknown. The reporter did not provide any causality assessment between events and PNEUMOVAX 23. Lot number I024132 is an invalid lot number for PNEUMOVAX 23. Additional information has been requested.
Fever; chills; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 for COVID-19 immunization. The patient experienced Fever and chills 1 day after receiving second dose of Pfizer COVID vaccine. Event took place after use of product. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Soreness at injection site with erythema, swelling noted by patient. She went shopping for 4 hours so did not apply ice pack we gave her until later that night and did not take any ibuprofen to help with pain/swelling only Benadryl 25mg. She came to clinic this morning at 9am with no swelling but 2 inch diameter area of erythema, heat and discomfort with movement of left arm. Did not apply ice pack since night before. Reapplied ice pack and told to take one tab of 200mg ibuprofen since no allergies/reactions to this med and to see MD if it exacerbates over weekend.
2 days after getting ZOSTAVAX pt presents to my office w/ herpetiform rash (L) chest (L) breast and malaise no fever. Still being treated w/ VALTREX.
vomiting, diarrhea, severe body aches and pains, fever, patient reports that severity required an ambulance trip to emergency room 4/3/21