chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills and Fever night of the vaccine.  Mild Nausea the following day.  Mild headache for slightly more than one month following the vaccination.
Rapid heartbeat, Red and painful swelling at shot site, Stiff neck, Swelling under left eye. Shot in left arm.
Headache, Rash, UrticariaPruritus, Diarrhea & NauseaVomiting Narrative: Employee stated after receiving 2nd vaccine she had a headache, then around 6pm she began to vomit, diarrhea, nausea persisted and then noticed rash on arms and ches.
Warm, Red, swollen & itchy at injection site- about a week post shot. Initially it was just achy about 3 days then fine.
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 05-FEB-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml Vls 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 27 degrees Fahrenheit (-2.77 degrees Celsius) (lowest recorded temperature) for 875 hours (sum of hours in excursion). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
father called PHN to report continuous crying since 1/25/94 & 102 fever w/ tylenol given every 6 hrs;
2/6/21:   10:00 am:  tired, acy body, sore on vaccination site.    2:30 pm: Fever of 101.8, took ibuprofen and rested  2/7/21:  8:00 am:  no fever or body aches.
This spontaneous report as received from a nurse practitioner via company representative refers to a 32 year old, non-pregnant female patient. The patient's concurrent conditions included cancer (not specified). On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscularly, dose, lot# and expiration date were not reported. On an unknown date, the patient was diagnosed as developing cellulitis at the site of injection for an unspecified amount of time. The patient sought medical attention. The patient was prescribed antibiotics (unspecified) for an unspecified amount of time. It was reported, that on an unknown date, the cellulitis did go away after an unspecified amount of time. The patient was left with a small indentation at the site of injection. The relatedness between the event and PNEUMOVAX 23 was not provided. Additional information is not expected, because there was no consent to contact the reporter.
Large - golf ball sized welt at site of injection post injecting. Cold pack applied to site to minimize reaction/swelling.
Pt describes sharp pain at the time of injection. Initially the area was red and sore for about 1 week. She states pain is more intermittent now but has not gone away and radiates down her (left) arm. Palpation of the site reproduces the sharp pain.
Vaccines administered in L thigh on 12/18/08.  On 12/26/08, 4 vesicles appeared @ injection site.  Slight firm mass underneath, some discomfort.
Patient reports being at work, starting to look pale, then feeling "like she was having a stroke" on the whole right side of her body. Her joints all became inflamed (possibly related to her rheumatoid arthritis)
muscle pain; tiredness; headache; shivering; low-grade fever to 100.0; I am now due for my second shot; This case was reported by a consumer and described the occurrence of muscle pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced muscle pain, tiredness, headache, shivering, fever and incomplete course of vaccination. On an unknown date, the outcome of the muscle pain, tiredness, headache, shivering, fever and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the muscle pain, tiredness, headache, shivering and fever to be related to Shingrix.  Additional detials were provided as follows: The age at vaccination was not reported. The reporter stated that, after vaccination had muscle pain, tiredness, headache, shivering, lowgrade fever to 100 degree F. The patient was due for 2nd dose and till the time of reporting did not received 2nd dose of Shingrix, which led to incomplete course of vaccination.      Lab Comments: Lab test performed on an unknown date
2nd dose given too early, 1st dose 2/7/21 2nd dose 3/2/21
Approx 30 minutes after injection, throat became scratchy, felt a little lightheaded. Then felt throat start to close up. Started experiencing shortness of breath, stridor, swelling of tongue and throat. Presented to Urgent Care within 20 mins of symptoms onset @ 3:21pm - received atrovent, xopenex, solu-medrol, pepcid, benadryl. Discharged to home with Medrol Dosepak at 5:13pm
pt presents to ED with shallow breathing and unresponsive; O2 supplementation; family did not want BiPAP to be used; DNR/DNI; pt in respiratory distress; found to be positive for COVID; COVID pneumonia; pt experienced hypoperfusion, hypokalemia; comfort care; pt trasferred to in hospital hospice care where she passed away
They administered three 3rd doses for immunocompromised patients on 20Oct2021 that expired on 13Oct2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They administered three 3rd doses for immunocompromised patients on 20Oct2021 that expired on 13Oct2021) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They administered three 3rd doses for immunocompromised patients on 20Oct2021 that expired on 13Oct2021). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (They administered three 3rd doses for immunocompromised patients on 20Oct2021 that expired on 13Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.  No treatment medications were reported.
Pt received both FLUVIRIN and ZOSTAVAX at the same time. He reported feeling extremely dizzy and sat down. He fainted shortly after. He sweated and urinated while he became unconscious. He woke up about 2 minutes later and was still dizzy. Called 911 and taken away via ambulance.
small pinpoint, raised, itchy red bumps; small pinpoint, raised, itchy red bumps; redness at the site post injection; Initial information received on 17-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 51 years old female patient who experienced small pinpoint, raised, itchy red bumps, and redness at the site post injection after receiving Influenza Quadrival A-B Vaccine [Fluzone Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Sep-2023, the patient received 0.5 ml of suspect Influenza Quadrival A-B Vaccine Suspension for injection (lot number: UT8076NA) (Expiry date: 30-Jun-2024) (Strength: Standard) (Frequency: once) via intramuscular route in the right deltoid for immunization.  On an unknown date, the patient developed small pinpoint, raised, itchy red bumps (rash papular) (rash pruritic) and redness at the site post injection (vaccination site erythema)  (unknown latency).  It was reported, Caller reporting 4 of their employees have experienced reactions after receiving FLUZONE QIV PFS, administered at their clinic as part of employee health. Caller reporting 3 patients have complained of ongoing arm discomfort and one patient experienced redness around the injection site. Caller reporting, she is concerned about continuing to use this batch of vaccines, she reports they have given over 70 FLUZONE QIV PFS and 4 have experienced reactions. Caller did not have any information as far as time frame of onset of symptoms. Caller also with question on whether we have any information we can send as administration guide as a reference for administration. Caller reports redness at the site post injection, unknown as far as time of onset, she thinks the following day after injection. Caller reports employee (patient) experienced small pinpoint, raised, itchy red bumps. Caller reports area is improving, no longer itchy and most of the red bumps have resolved on their own, patient does have a few small red bumps.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Recovering / Resolving for the events; Sender's Comments:  US-SA-2023SA322206:
I had a severe headache the night of the booster dose; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (I had a severe headache the night of the booster dose) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006D21A, 007B21A and 046B21A) for COVID-19 vaccination.     No medical history information was provided by the reporter.   Concomitant products included PREGABALIN (LYRICA), GABAPENTIN, BUSPIRONE, CLONAZEPAM and MORNIFLUMATE (FLOMAX [MORNIFLUMATE]) for an unknown indication.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (I had a severe headache the night of the booster dose). At the time of the report, HEADACHE (I had a severe headache the night of the booster dose) had resolved.      Treatment information was not provided by the reporter.   This case was linked to MOD-2021-085633, MOD-2021-085673 (Patient Link).
Information has been received from a news article via a journalist in a website referring to unspecified number of patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with doses of GARDASIL (dose, dose number, lot number, application and route were not reported). According to the research of Centers for Disease Control and Prevention, the researchers looked at problems reported to the Vaccine Adverse Events Reporting System in the 2.5 years since GARDASIL was licensed. Overall, 93.8 percent reported problems were considered non-serious. The exact adverse events were not reported. It was reported that these types of reports could not determine whether adverse events were caused by the vaccine or just a coincidence. This is one of several reports received from the same source. Additional information is not expected since there was no contact details provided.
She nowhas Transverse Myelitis; Paralyzed from the waist down; This spontaneous case was reported by a consumer and describes the occurrence of MYELITIS TRANSVERSE (She nowhas Transverse Myelitis) and PARALYSIS (Paralyzed from the waist down) 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 21-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYELITIS TRANSVERSE (She nowhas Transverse Myelitis) (seriousness criteria disability and medically significant) and PARALYSIS (Paralyzed from the waist down) (seriousness criteria disability and medically significant). At the time of the report, MYELITIS TRANSVERSE (She nowhas Transverse Myelitis) and PARALYSIS (Paralyzed from the waist down) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that we have acquired numerous hospital bills and now have to modify our home and vehicle.  This case concerns a female subject of an unknown age, with no relevant history reported in this case, who experienced the serious unexpected events of Myelitis transverse (AESI) and Paralysis. The events occurred of an unknown date for an unknown date and schedule of administration of mRNA-1273 vaccine. The rechallenge is unknown for the events since no information about the dose sequence is provided. At the time of the report the outcome of the event was Unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a female subject of an unknown age, with no relevant history reported in this case, who experienced the serious unexpected events of Myelitis transverse (AESI) and Paralysis. The events occurred of an unknown date for an unknown date and schedule of administration of mRNA-1273 vaccine. The rechallenge is unknown for the events since no information about the dose sequence is provided. At the time of the report the outcome of the event was Unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Symmetrical, dark red flushing of skin, distally (appearing at bootie top to upper thigh to proximally.Superficial leg veins pronounced. Increased warmth to touch. Onset within 1 minute of completion of last injection. (Prevnar)
This study case was received from the investigator in a trial on 14 August 2013. A 24-year-old male subject was found to have other and unspecified acute myocarditis and non-specific myocarditis 11 days after receiving the following vaccines on 06 June 2013: an injection of ACAM2000 (lot number, route and site of administration not reported), Anthrax (manufacturer, lot number, route and site of administration not reported), and TYPHIM VI (sanofi pasteur SA, lot number, route and site of administration not reported). Relevant laboratory data included an abnormal Troponin I value of 00.15 (units not reported) on 17 June 2013, normal Echocardiogram on 17 June 2013, normal MRI of the heart on 20 June 2013. The results of ECG were not available. MRI of brain and spinal cord, and lumbar puncture were not performed. Treatments were not reported. The subject had no significant past medical history. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
pt recv vax 18MAY95 & 20mins later exp grand mal sz;hosp;addtl info recv 6JUL95 pt had sustained grease burns to thigh, foot, & both arms & hands;tx in ER given Td vax;20min later pt became disoriented;incontinent of stool;
Severe headache Fever 102.7 Severe body aches Chills Severe pain at injection site
No adverse effects; VARIVAX was administered following temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. Concomitant medications included sterile diluent (STERILE DILUENT).   On 01-JUN-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter, lot #U020244, expiration date: 28-JUN-2023, (strength and route of administration were not provided) for prophylaxis (Product storage error).  On 15-MAY-2022, the varicella virus vaccine live (oka/merck) (VARIVAX) underwent temperature excursion at 6 degrees Fahrenheit (F) for 7 minutes. No previous temperature excursions were reported. No adverse events were reported (No adverse event).
crohn's spread from large intestine to small intestine/flare up of crohn's disease; pain; temperature; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 22K-163-4385075-00 (Company).  A 20-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen (Batch/Lot number: unknown) at citrate free (1 in 2 weeks) and second regimen (Batch/Lot number: unknown) at citrate free (1 in 10 days), all subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CROHN'S DISEASE (medically significant), outcome "not recovered", described as "crohn's spread from large intestine to small intestine/flare up of crohn's disease"; PAIN (non-serious), outcome "not recovered"; PYREXIA (non-serious), outcome "recovered", described as "temperature". The patient underwent the following laboratory tests and procedures: Diagnostic procedure: Crohn's had spread, notes: Crohn's had spread from large intestine to small intestine. The action taken for adalimumab was unknown. Clinical course: On unknown dates, the patient experienced Crohn's spread from large intestine to small intestine/flare up of Crohn's disease, pain and temperature. On an unknown date, temperature resolved. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter did not have the lot number information, because the information was not available in the patient's file.  The reporter's assessment of the causal relationship of "crohn's spread from large intestine to small intestine/flare up of crohn's disease" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "pain" and "temperature" related to BNT162b2.  Causality for Humira (adalimumab): the reporter's causality for the event(s) of Crohn's spread from large intestine to small intestine/flare up of Crohn's disease with Humira (adalimumab) was a reasonable possibility. the reporter's causality for the event(s) of pain and temperature was not provided.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Tinnitus-ringing in ears. Ears began ringing one day after shot and has been ringing for 6 days nonstop; This is a spontaneous report from a contactable consumer (patient). A 42-Year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration in the left arm on 02Feb2021 at 14:45 (at the age of 42-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. The patient had no 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 didn't receive any other vaccines within 4 weeks prior to the COVID vaccine and didn't receive any other medications within two weeks of vaccination. On 03Feb2021, at 16:00 the patient experienced tinnitus-ringing in ears. Ears began ringing one day after shot and has been ringing for 6 days nonstop. The patient visited physician office. It was unknown whether the patient received any treatment for the event. The event was reported as non-serious by the reporter. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Stroke; Meningitis; Suspected vaccination failure; Seizure; Pink Eye; Low immune system; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Men ACWY-CRM NVS (Meningitis ACWY vaccine (potential Menveo)) for prophylaxis.   On an unknown date, the patient received Meningitis ACWY vaccine (potential Menveo). On an unknown date, unknown after receiving Meningitis ACWY vaccine (potential Menveo), the patient experienced vaccination failure (serious criteria GSK medically significant), meningitis (serious criteria hospitalization and GSK medically significant), stroke (serious criteria hospitalization and GSK medically significant), seizure (serious criteria GSK medically significant), pinkeye and immune system disorder. On an unknown date, the outcome of the vaccination failure, meningitis, stroke, seizure, pinkeye and immune system disorder were unknown.   It was unknown if the reporter considered the vaccination failure, meningitis, stroke, seizure, pinkeye and immune system disorder to be related to Meningitis ACWY vaccine (potential Menveo).  Additional information was provided as follows: The age at vaccination was not reported. The patient had received a Meningitis ACWY vaccine (potential Menveo). After vaccination, the patient was hospitalized due to developing Meningitis for 10 days. During hospitalization the patient also had a stroke. About 10 years later now at the time of reporting, the patient was experiencing seizures, and has a low immune system. The patient gets pink eye very often as well. The reporter did not know the exact name of the vaccine that was given to her daughter. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting.
On 10/20/2003 the child noted to have fever (low grade) and gradual development of spots over most of body from scalp to thighs. Classic appearance of chicken pox.
pt recv vax 19SPE96 & 23SEP96 pt exp muscle atrophy @ inj site;
This case was reported by a pharmacist and described the occurrence of arm pain at injection site in a 39-year-old female subject who was vaccinated with FLUARIX QUADRIVALENT (GlaxoSmithKline). On 22 August 2014, the subject received unspecified dose of FLUARIX QUADRIVALENT (.5 ml, unknown route, unknown arm and batch number). On 23 August 2014, 1 day after vaccination with FLUARIX QUADRIVALENT, the subject experienced arm pain and small blisters, both at injection site. At the time of reporting, the events were unresolved.
ON 11/4/2021 STARTED WITH ITCHING ON A SMALL SPOT ON LEFT SIDE OF BODY PROGRESSING TO A HORIZONTAL THIN RED RASH ABOUT 5 INCHES LONG BY 11/5/21. SAW MD ON 11/9/21. PATIENT CLAIMS THE VACCINE CAUSED A CASE OF SHINGLES. RESOLVED BY 11/15/21.