chrisvoncsefalvay/vaers-outcomes huggingface dataset:
29OCT97 deltoid sore to touch, no hurt when move-knot could be felt @ inj site;3NOV97 deltoid sore to touch, no hurt when move arm;knot same as 29OCT97 15mm x 17mm;area around knot red & warm to touch;4NOV97 knot present;welt inj site;
pt recvd vax on 2DEC92 & exp severe burning @ the time of the inject; 2 hrs follwoing vax exp intermittent dizziness upon standing or bending which persisted for 3 1/2 hrs; injected arm very painful from elbow to mid-deltoid;
I experienced on or about 05-02-2021; started to smell ammonia and it continued for awhile, it was a constant smell all the time then it would kind go and comes. I got concerned about my kidneys. I had some discomfort very slight in my abdomen area and I also had some headaches. I did not call the doctor right away, waited about two weeks. I did go see my doctor on 05-13-2021. I had  full physical exam, blood panel, ordered at CT scan of head, have history of lymphoma, non-Hodskin type, that was in the tonsils and asked that I see a ENT specialists to rule out any problems with my sinuses on 06-08-2021. I saw an ENT, also did a sniff test, and there was no problems, no evidence of growth. I also pretty much aced the sniff test. Then my doctor ordered on 06-24-20201 an U/S of my kidney and bladder and another lab work up. The GFR was 53 in May 2021 then on 06-24-2021 my GFR  was 55.  I still have the ammonia smell but it is less frequent. I have scheduled a colonoscopy and will see what that turns out and will monitor with my doctor and then if my numbers do not improve then the next step of treatment is to see a nephrologist.  I do not know that if what I experience is related to the vaccine. I have never had any trouble with my kidneys in the past.
was improperly reconstituted with sterile water instead of the supplied diluent; Initial information received on 11-Oct-2021 regarding an unsolicited valid non-serious case from a physician via Media Information (under the reference 00806397).  This case involves a 15 months old female patient who was vaccinated with YELLOW FEVER VACCINE [YF-VAX] and STERILE WATER which improperly reconstituted with sterile water instead of the supplied diluent (product preparation error).   The patient's medical history, medical treatment(s), concomitant medication(s) and family history were not provided.  Patient had no other vaccines.  On 05-Oct-2021, the patient received a dose of suspect YF-VAX (0.5 ml, total, lot UJ386AA and expiration date: 22-aug-2022) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient received a dose of suspect STERILE WATER not produced by Sanofi Pasteur (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  It was an actual medication error due to Wrong solution used in drug reconstitution.  No adverse event reported.   It was reported "Caller wants to know if there are any issues with administering another dose. MD (Doctor of Medicine) is a pediatric infectious disease specialist, consulting as to how to manage the above situation. How do I approach properly vaccinating this child so she can go visit her family? When information was shared from the "Use of Alternate Diluents" SRD (system requirement document), he then asked, since it is a live vaccine, should there be an interval between the time of the improperly-reconstituted dose and a re-dose, such as 28 days?"  At time of reporting, the outcome was unknown for the 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Rotateq was given after the temperature excursion; This spontaneous report was received from a nursing assistant and refers to a patient of an unknown age and gender. There was no information about the patient's concomitant therapies, concurrent conditions or medical history provided.  On 30-MAR-2021, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1660998, expiration date 03-MAY-2021, 2 milliliter, orally (anatomical location was not provided) for prophylaxis. The administered vaccine experienced the temperature excursion of 8.8 degree Celsius (C) for 6 minutes. Data logger was not involved. There were no previous excursions reported.
Fever for 2 days, swelling of left deltoid (injection site).  History of fainting after 5 hours of injection and lasted for 2-3 minutes.  Seen by MD on 10/16/2003.
Information has been received from a physician concerning a 65 year old male with penicillin allergy who on 12-JUL-2007 was vaccinated subcutaneously in the left deltoid with a 0.65 mL dose of Zostavax (Oka/Merck) (lot# 656609/0015U).  Concomitant therapy included LAMISIL.  On approximately 19-JUL-2007, one week post vaccination the patient developed shingles: 3 vesicular lesions and pain on left orbital, pain at back of left scalp and left ear.  The patient went to the emergency room and was treated with prednisone but was not hospitalized.  Patient was diagnosed with poison ivy.  Two weeks later he visited his doctor for a follow up.  Patient is recovering from shingles but still experiencing pain.  Additional information has been requested.
Febrile seizure, TMAX 101.7. Pt seen and discharged from ED.
Pt had c/o HA, fatigue, nausea, diarrhea, chills, sweats, dizziness, very sensitive skin/sensitive to touch, mid back pain shooting down back, entire right side of body that radiated down to right leg  pain, pain in right shoulder,
Tingling on right side (face, arm, hand, leg, foot); Numbness on right side (face, arm, hand, leg, foot); Sensitivity to noise; weakness on right side (face, arm, hand, leg, foot; Head fuzzy; Head pressure; headaches; Ears ringing; Pain (face, arm, hand, leg, foot); This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 21Apr2021 at 09:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not receive any medication within two weeks of vaccination. The patient did not have any relevant medical history. 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. On 21Apr2021 at 19:00, the patient experienced head fuzzy, head pressure, headaches, ears ringing, pain, then numbness/weakness/tingling on right side (face, arm, hand, leg, foot) and sensitivity to noise. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events was head fuzzy, head pressure, headaches, ears ringing, pain, then numbness/weakness/tingling on right side (face, arm, hand, leg, foot) and sensitivity to noise was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
The left side of my face began to go partially numb on occasion and at times would spread to the right side of my face. The Sunday after the shot which was my 2nd dose, I passed out and paramedics were called. I didn't go to the hospital then but the following Wednesday I felt my face go very numb again so I went to the hospital. They ran a CT scan and blood work &everything looked normal. I followed up with my PCP that week per instruction of the er and as my face was still getting numb and my left leg and hand began periodic jittering. As the day I passed out I had used marijuana, poppy tea and kratom for endometriosis pain, I stayed away from everything to make certain the vaccine was causing the side effects and not the substances. Even without using anything for days and ultimately weeks, the numbness and tingling continued and at times would last for hours. When I first had the initial shots, it jumpstarted my period both times by 2 weeks and I started the same day as the vaccine each time. I was okay with that side effect but these were more worrying. I have more tests scheduled including wearing a heart monitor for 48 hrs,  a dental checkup to make 100% sure nothing abnormal there is causing the effects and a neurologist appt lastly if nothing is uncovered otherwise. An appointment for my heart monitor is already scheduled in early June
PT TOOK COAT OFF, REALIZED HER ARM WAS A LITTLE ITCHY, NOTED A 3" DIAM , RAISED PINK , WARM RASH. ADVISED PT TO PUT COLD COMPRESS AND RETURN TO CLINIC ON 11/15/2010.
unsure received any of the vaccine; squirted on patient's arm; squirted on patient's arm; This case was reported by a other health professional via call center representative and described the occurrence of incomplete dose administered in a 34-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th September 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 28th September 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-Sep-2022 Reporter's comment: The healthcare professionals reported that needle felt blocked and the Flulaval squirted on the patient's arm.  The healthcare professionals was unsure if patient received any of the vaccine. The healthcare professionals stated that no issue with the PFS, they had notified the manufacturer of the needles due to previous issues.  There was no product quality complaint noted. The reporter consented to follow up. The follow-up was not possible as per the process convention. Additional Supportive Information: The needle felt blocked and the Flulaval squirted on the patient's arm, which led to incomplete dose administered, exposure via skin contact and inadvertent exposure to vaccine.
Pt recv vax on 12/4/98; on 12/5/98 pt exp headache, body aches, chills, night sweats, runny nose
PARALYZED FROM THE WAIST DOWN; LOSS OF FEELING IN HANDS; This spontaneous report received from a patient from social media via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose were not reported,1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient was paralyzed from the waist down with loss of feeling in hands. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from paralyzed from the waist down with loss of feeling in hands. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210724242- Covid-19 vaccine ad26.cov2.s - Paralyzed from the waist down . This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Patient has a history of redness and swelling at injection site with flu and pneumonia shots in October 2020. Feeling dizzy 10 minutes after injection. Diabetic. Offered water. Patient fine sitting up.   MD note: 65 year old male who complained of dizziness, lightheaded, 10 minutes after injection. Patient feels better but has slight dizziness. No other complaints. No loss of consciousness, cardiopulmonary issues. Exam: unremarkable. Plan: Home and follow-up with primary care provider.
Three damaged Prevnar 13 syringes/Two of the Prevnar 13 syringes actually broke at the neck and another Prevnar 13 syringe leaked when put the needle on; The initial case was missing the following minimum criteria: reportable event. Upon receipt of follow up information on 23Mar2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group.  A child patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Lot number: GD1168, Expiration Date: Apr2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYRINGE ISSUE (non-serious), outcome "unknown", described as "Three damaged Prevnar 13 syringes/Two of the Prevnar 13 syringes actually broke at the neck and another Prevnar 13 syringe leaked when put the needle on".  Additional information: NDC number of Prevnar 13: 0005197101. Three damaged Prevnar 13 syringes: Two of the Prevnar 13 syringes actually broke at the neck and another Prevnar 13 syringe leaked when put the needle on and went to administer, or well when just had gotten air out. Fortunately, was not in kids leg, leaked straight out of middle neck part. The reporter would like to know if Pfizer would give credit. They still had the Prevnar 13 syringes. Occurred fortunately before and another Prevnar 13 syringe was gotten out to be used. The reporter also clarified there were three separate patients involved, all prior to administration when preparing drawing up and never really got in room with the patients. The reporter did not have the patient information on hand to complete individual reports. Did not make to patient; therefore, the reporter did not keep the patient information. Unable to clarify which Prevnar 13 were involved with which patient. Unable to also clarify which Prevnar 13 were involved with which occurrence. The sample of the product was available to be returned.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300129299 Same reporter/ vaccine/ AE, different patients.;US-PFIZER INC-202300129343 Same reporter/ vaccine/ AE, different patients.;
Patient came in for Hep A and Hep B Vaccines. Patient was given both vaccines at time of visit. Patient was given Adult Hep A and accidently given Peds Hep B which is a half of dose less than the adult dose. Patient notified and will be back in 4 weeks his next dose.
patient has not reported any side effects or symptoms at this time; Product was administered today, 31AUG2023 however it expired on 29AUG2023; This spontaneous report was received from a nurse referring to a 70-year-old male patient. The patient's medical history and concurrent conditions were not provided. Concomitant therapies were not reported.  On 31-AUG-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (lot #U032086 with an expiration date on 29-AUG-2023), administered for prophylaxis (strength, dose, and route of administration were not provided).  The patient did not report any side effects or symptoms at this time. Vaccine was administered however, it expired on 29-AUG-2023. No temperature excursions were reported.
Day following vaccine patient develops nausea, vomiting, diarrhea and fever. Thursday lungs felt tight and she started coughing - Monday she went to hospital for hydration. Tuesday ER for episode of SVT. ER by ambulance admitted to Telemetry for a day of monitoring. By noon the next day she was in the ER again for another SVT episode - and again back in ER at midnight - chest X-ray and diagnosis of walking pneumonia given. 12 hours later she was back in the ER with SVT and was admitted to Telemetry overnight in SVT. She was treated with antibiotics and symptoms slowly improved. Known Tetanus vaccine approximately 7 years ago.
given a lesser dose; A spontaneous report was received from a consumer concerning a 67-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an accidental underdose.  The patient's medical history was not provided.  Concomitant medications were not provided.  On 12 FEB 2021, the patient received her first dose of mRNA-1273 (lot number 031M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  The patient was called thirty minutes after receiving her first dose of the vaccine by the pharmacist to have her come back to the facility.  The pharmacist explained that there was a medication error and they wanted to make sure that the patient got the full dose.  Treatment for this event was not reported.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, accidental underdose was considered recovered.; Reporter's Comments: This case concerns a 67-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot: 027L20A), reporting accidental underdose without any associated adverse events.
This spontaneous report was received from a nurse refers to 31 patients of unknown age and gender. No pertinent medical history was reported. On an unknown date, 31 patients were vaccinated with improperly stored GARDASIL (dose, route, lot# were not reported). No adverse effects reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
This case was reported by a healthcare professional via a distributor and described the occurrence of flu-like symptoms in a female subject aged between 60 and 69 years old who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLULAVAL (0.5 ml, unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced flu-like symptoms. Medical attention was not required. At the time of reporting the event was resolved. The healthcare professional considered the event was probably related to vaccination with FLULAVAL. At the time of reporting, the healthcare professional reported five other adult female subjects who experienced side effects from FLULAVAL injections at her practice (see case id's A0887614A, A0887616A, A0887617A, A0887618A, and A0887619A for specific details on these other subjects). It was unknown if all six subject's FLULAVAL was administered from the same vial. Follow-up information was received on 29 October 2010. It was reported that the subject was 65 years old and that she received FLULAVAL on 01 October 2010. She developed flu like symptoms on 06 October 2010. The event resolved.
Patient developed symptoms of Guillain-Barre syndrome on January 15, 2021 and was admitted the Hospital. She was diagnosed and eventually required ICU level care and has been treated with plasmapheresis. She is currently still in the ICU but is stable.
Broke out in rash (very small bumps not red but raised) on legs along with blotches on legs .  slowly moved up my body, rash now is on chest and back, legs are clear.  very itchy.
headache, body pains, fever, chills, nausea  - all of them are severe in nature.  Started having periods on the same day and before  vaccination 5/2/2021.   Took 2 Motrin (200mg each) once in the morning and once in the night which provided some relief.
Complains of walking more slowly more so 6 weeks after vaccine -Janssen.  He has stiffness in hands.  Has not been able to return to work since 7/16/2021.  He has had history of Gillian Barre in 1999.
-Fever & headache day after injection (8/13)  -Had Temp 101 & swollen (L) armpit & tender @ injection site on 8/14. -Chest pain 8/15 - To ER. Elevated troponin Labs- BMP, CRP, CBC, CMP, COVID-neg. flu A&B neg CT - Chest/abd - (L) axillary lymphadenopathy Meds: indomethacin & cholchocine
12/21/2020 I had my first Pfizer COVID-19 vaccine and the second on 1/13/2021. Two days after my second vaccine on 1/15/2021 at 8:50 PM I had a scintillating scotoma in my right visual field in both eyes consisting of a bright flash of light in the center of my visual field that cleared but then it expanded into a C-shaped series of zig-zag lines that slowly expanded into the periphery of both right visual fields. It ended at 9:20 PM. I had no headaches afterward. While I have had migraines when I was younger, I haven?t had one in several decades and I never had an aura before it.   I went to the ED where I was evaluated for a possible TIA and then admitted into Hospital. While there my platelet count was 400% of what it usually was.  Other than the platelet count and anemia (I donated 2 unit of packed red blood cells on 12/17/2020) the rest of my blood work was unrevealing.   The scintilating scotoma only lasted 30 minutes but the elevated platelets (although slowly coming down) continues to this day.
Localized redness distal to injection site -> with appearance of initial stage of cellulitis.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  No treatment medication were provided.   This case was linked to MOD-2021-395985 (Patient Link).
This spontaneous report was received from a pharmacist who reported that five infant patients between 2 and 10 months of age (gender not provided) were inadvertently administered a third dose of LIQUID PEDVAXHIB (dose, route, frequency and lot # not provided) two months after a second dose. No adverse effects were reported. Additional information has been requested.
Waited 15 minutes after being administered vaccine-left facility and 30 minutes after receiving vaccine the sides of my tongue became numb/tingly.  This subsided after 3.5 -4 hours
Redness and warmth inferior to (R) deltoid. Started 2/10/16- looks as above 2/12/16. States he feels better.