chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from an office manager concerning a 54 year old female patient with no pertinent medical history and no known drug allergies/drug reactions who on 15-DEC-2008 was vaccinated with a 0.5 ml dose of PNEUMOVAX (Lot # 661065/1021X) intramuscularly.  There was no concomitant medication reported.  It was reported that "within 24 hours after the vaccination" the patient developed an injection site reaction.  It was reported that the patient's arm became red, swollen and tender.  The patient did not seek attention.  It was reported that the patient applied ice to the area.  There  were no laboratory diagnostic tests performed.  It was reported that the patient had recovered at the time of the report.  Additional information has been requested.
pt recv vax AUG96 & AUG96 devel a high fever of 105 & a diffuse rash;no further details were provided;
patient can't take the flu shot. They caused the patient flu; patient got sick every time; Initial information received on 02-Feb-2021 regarding an unsolicited valid non-serious case received from a consumer (patient).  This case involved a patient of unknown age who can't take the flu shot. they caused the patient flu (influenza) and got sick every time (illness), while patient received vaccines INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MALUS SPP. VINEGAR EXTRACT (APPLE CIDER VINEGAR) and AMYLMETACRESOL; DICHLOROBENZYL ALCOHOL (ROBITUSSIN).  On an unknown date, the patient received INFLUENZA VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, patient who can't take the flu shot. they caused the patient flu (influenza) and got sick every time (illness) (latency: unknown) following the administration of suspect vaccine.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown.  There will be no information available regarding batch number in this case.
Systemic: Chills-Severe, Systemic: Shaking, contracted fingers bil-Severe, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Weakness-Medium, Additional Details: Returned call to pt.  Pt reports chills, shaking, headache, weakness, nausea, and contracted (fingers spread out and could not bend them) fingers bil hands for about 2.5 hours about 8 hours after injection.  Symptoms resolved quickly and have not returned.
Information has been received from a physician concerning a 8 year old male who on 02-NOV-2000 was vaccinated with a first dose of MMR II. On 13-AUG-2007 the patient was vaccinated with a second dose of MMR II. It was reported that the patient did not receive the third dose of MMR II. It was reported that the patient was not vaccinated with a third dose. On 23-JAN-2010 the patient experienced mumps. The patient was diagnosed with mumps on 25-JAN-2010. Other symptoms presented by the patient included right parotitis and pain the right ear. First blood work test performed on 25-JAN-2010 included IgM (<1:10), IgG (9.62) and amylase (516). Second blood work was not performed. The final outcome for mumps was not reported. This is one of several reports from the same source. No further information is available.
sore throat, headache, swelling  and very, very sore feeling in the left arm, tingling in the tips of fingers (feeling pricked in the fingertips).
Vaccines administered 5-25-10 at 12noon approximately 5-26-10 circled area approximately 3cm in diameter noted hard, red with small amt of swelling, 5-27-10 12noon increased swelling hot and itching: cold compress applied. At 800pm took to ER for evaluation.
02/24 Started on Amoxicillin for ear infection and fever. 02/27 6 month well checkup received immunizations, no fever. 02/28 Fever 103, jerking.  Given Tylenol and Motrin.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown gender and age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 10-APR-2015, the patient was inoculated with ZOSTAVAX by a healthcare provider as recommended for permanent prevention and protection against shingles and zoster-related conditions (dose, route, and lot # not provided). On an unknown date, the patient was diagnosed with shingles and/or zoster related injuries after and despite being inoculated with ZOSTAVAX vaccine and suffered serious mental and physical pain and suffering and required extensive medical care and treatment. On or about an unknown date in 2016, the patient was treated by a healthcare provider for shingles. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other medical related expenses which includes but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Fever, vomiting, nausea, achiness and diarrhea beginning evening of 08/29/2022.  Symptoms continued and worsened over the next 24 -36 hours.  Patient presented in ER on 08/31/2022 and was admitted to hospital.  Patient discharged on 09/03/2022.
Low grade sinus Sx's (congestion) prior to vaccination. Full blown illness: sinus pain, congestion, aches, joint pain, fatigue, malaise developed 3-4 days ... req. 1 wk absence from work and prolonged recovery time.
Subsequent to receiving one dose of varicella virus vaccine live the pt experienced a case of chickenpox worse than most non-immunized pts.
Severe neuropathy. Muscle weakness. Nerve pain. Tremors. Loss of balance.
Pt red'd flu vaccine which caused a local reaction in her arm She denies being allergic to eggs. She is currently being treated for an abcess in her arms with antibiotics. She does not have a rash or edema. The patient is a 26-year-old woman with Devic's disease who experienced recurrence of right-sided weakness and paresthesia with severe weakness of the right leg of new onset and exacerbation of right optic neuritis with loss of vision in the right eye.  This was temporarily associated with the development of an area of erythema and tenderness consistent with cellulitis at the site of recent immunization in the right deltoid.  The patient is on immunosuppresant therapy with chronic prednisone, recent courses of high-dose methylprednisolone, and mitoxantrone treatment.  In spite of this rather aggressive treatment, she has had problems with recurrent bouts of myelitis everytime that her steroids have been reduced.  Because of the cellulitis and her worsened symptoms, she was admitted for evaluation and treatment.  The patient received an initial dose of methylprednisolone given the appearance of cellulitis with possible abscess.  Attempts were made to obtain culture by needle aspiration.  There was no discrete fluctuant mass, however and no pus could be obtained in spite of an area of considerable swelling and erythema.  Ultrasound did not demonstrate an abscess.  Cultures were negative.  Treatment with high doses of intravenous antibiotics eventually resulted in the marked improvement.  This took several days in spite of the 250-mg dose of methylprednisolone that she received initially.  Because of the possible effects of her multiple sclerosis and her recalcitrant course, famciclovir and atorvastatin were begun.  The patient was discharged on these medications, in addition to her usual prednisone and an oral course of ceftriaxone and metronidazole.  The patient was to return to clinic for outpatient followup.  Annual follow up on 12/23/03, 12/24/03: " (Completed by) person is not known to hospital."
Suspected vaccination failure; Had the shot and still got the Shingles; This case was reported by a consumer described the occurrence of suspected vaccination failure in an adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was captured as adult as per vaccine indication. The patient had the shot and got the Shingles. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Information has been received from a consumer concerning her 15 year old daughter with a history of acne who in Spring 2008, was vaccinated with her first dose of GARDASIL. Concomitant therapy included tetracycline. After vaccination the patient fainted straight away. The patient also experienced serious issues with her eyes and redness at the injection site. The second and third doses were not administered due to complication from the first dose. The outcome of the patient's fainted straight away, serious issues with her eyes and redness at the injection site was not reported. No further information is available.
Two weeks post MMR administration presented with erythema multiforme minor complication on diagnosis for finger infection from 8/4/02 getting better.
Within 24 hrs of vaccinations I get nosebleeds usually late at night or early morning; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the right arm on 12Apr2021 at 12:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 infection. The patient had no known allergies. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the right arm on 19Mar2021 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient experienced nose bleed which lasted for 4 days. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 13Apr2021 at 11:30 the patient experienced nosebleeds within 24 hours of vaccination usually late at night or early morning. They were sudden and took 10 min to usually stop. No therapeutic measures were taken as a result of adverse event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event nosebleeds was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected
Pentacel reached 33.5C; Initial information received on 11-Jul-2019 regarding an unsolicited valid non-serious case received from an other healthcare professional.  This case is linked to cases 2019SA192618, 2019SA192651, 2019SA192652, 2019SA192653, 2019SA192654, 2019SA192655, 2019SA192656, 2019SA192657, 2019SA192659 and 2019SA192660 (same reporter).  This case involves a nine weeks old patient who was vaccinated with a 0.5 ml first dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ014ABA and Exp. Date 26-Oct-2020) via intramuscular route in unknown administration site on 09-Jul-2019.  This vaccine was reached at 33.5C.  The patient's medical history not reported and concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) both received 0.5 ml dose via intramuscular route on 09-Jul-2019 for Immunisation.  It was an actual medication error case due to incorrect product storage.  It was unknown whether the patient experienced any adverse event post vaccination.  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 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.  List of documents held by sender: none.
Tender, warm to touch, swollen, itchy rash at injection site within 24 hours of second dose-given on opposite arm than first dose
Got Pneumonia vaccination and my upper arm became painful, red and swollen from my shoulder to my elbow. Over the next 4 days it gradually went away.
36 hours, post vax, pt developed urticarial rash, including right ankle swelling that progressed to include an erythema multiforme rash on trunk and ear with mouth, lip, hand and foot swelling. Much improved after dose of Prelone but not yet, fully.
Broke out in rash. Told me it was scabies and then bed bugs. Both were treated and nothing worked. It is still going on.
Localized swelling and itching L arm at site of injection; given ZYRTEC, ibuprofen, hc cream; will continue to f/u at school clinic.
Pt presented with 30-50 lesions on arms and trunk. Afebrile. Dx with Varicella.
Patient was seen for a physical exam on 9/6/16 and was given MENVEO, left deltoid, mother state that patient was c/o swelling and pain to left deltoid that same evening, on 9/7/16 left deltoid was worse, warm to touch and pain. On exam on 9/8/16 seen for follow up PNP notice 16x16cm localize reaction and prescribe KEFLEX 250mg/5ml, BENADRYL prn. Pt to follow up on 9/12/16.
Fever, weakness, nausea, diarrhea for 36 hours + pain in left arm at site of vaccine with rash and itching for 5 days
Pt experienced generalized varicella lesions with fever of up to 102 with decreased appetite for several days.
pt felt fine immediately after getting Pfizer Covid vaccine, but passed out in the aisle within 5 to 10 minutes after receiving vaccine.  Didn't administer epipen, but called 911 and had paramedics on the scene quickly.   Paramedics started IV, monitored BP, and checked BS.  Pt stated hands felt tingly and almost lost consciousness more than once.   Ambulance arrived on scene and took pt to hospital.
Pt was given Moderna for the first Covid vaccine on 04/04/21 and was given  Pfizer as the second Covid vaccine on 05/02/21.  Pt did not appear to be in any distress and had no complaints
Roughly between 1400 and 1410 the patient received the Moderna vaccine in the right deltoid. Patient stated 5 minutes after injection the she felt "a warm feeling from my head to my chest area. Like a burning feeling". Since this symptom was not cardiac or respiratory in nature and the patient did not appear in distress, Benadryl 25 mg PO was administered roughly at 1415. Patient was closely observed afterward. Patient alerted staff 3 minutes after the Benadryl administration that she felt tightening in the throat and itchiness. Epinephrine was administer to left thigh. Patient stated immediate relief. Emergency medical services were offered, but the patient declined. The first set of vitals retrieved were 136/78 BP, 81 pulse, patient lung sounds clear, no wheezing present. Patient is awake and alert.  Onsite physician assessed the patient. Patient monitored for additional 30 minutes after epinephrine injection. Last set of vitals 120/81 BP, pulse 88, lunch sounds clear no wheezing. Patient is calm, awake, and alert. ODR clinical representative and patient educated on anaphylaxis signs and symptoms and advised to seek medical attention if symptoms occur. Patient released from observation at 1455.
lightheaded, nausea; B/P- 160-97, P-58, pulse ox- 96%. Client reports history of diabetes, took med this morning but had not eaten lunch. Client also past history of fainting with blood draws and injections
achy; fever, temperature; Headache; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (achy), PYREXIA (fever, temperature) and HEADACHE (Headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 026L20A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL for Hypertension, IBANDRONATE SODIUM (BONIVA) for Osteoporosis, VITAMINS for an unknown indication.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (achy), PYREXIA (fever, temperature) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, PAIN (achy), PYREXIA (fever, temperature) and HEADACHE (Headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided. No treatment medications were provided. The side effects weren't real bad but enough to keep the patient  home from work.   Most recent FOLLOW-UP information incorporated above includes: On 24-Aug-2021: Follow Up information was received on 24-Aug-2021 and first and second dose details were added, concomitant medications added,narrative updated, reporter occupation added.
Sore arm 1-2 hours after injection. After roughly 14 hours, I am experiencing flu like symptoms to include a fever (102F), sore throat, diarrhea, body/muscle aches, mild confusion, and lethargy.
Approximately 1-2 weeks after 2nd vaccine patient experienced dyspnea with exertion when running or walking fast going up stairs.  Symptoms are still ongoing at this time.
Admitted on 10/19/2022 for hypovolemic shock in the setting of small bowel obstruction and watery diarrhea. He was found to have EPEC on stool panel. New onset of rash on 10/29/22 and ID was consulted. The rash initially appeared on his back, then spread to involve all extremities, scalp, face, and genitals. The lesions appeared in different stages of healing, with some scabbed, some appearing vesicular, and some papular/possibly umbilicated on his lower back. his vesicle swab returned positive for varicella zoster, confirmed vaccine strain at clinic.
On 12/06/2000 the patient complained of "local tenderness, redness and a warm feeling at the injection site". The patient also experienced itching all over her body. The patient had no fever and no rash. Unspecified medical attention was sought. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 30-MAY-2014, the patient was inadvertently administered a 0.5 ml dose of PROQUAD (lot # and route were not reported) and a 0.5 ml dose of MMR II (subcutaneously, lot# not reported). Concomitant therapy was not reported. No adverse effects reported. Additional information has been requested.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 3:13 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 3:13 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 74.58 No concomitant medications were reported.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. No treatment medications were reported.
Employee diluted vaccine with wrong amount of diluent. The vaccine was not administered to any patient and was promptly reported to clinical leadership.
Headache, Myalgia, NauseaVomiting, inj site pain/itch/swelling; chills, fatigue, body aches, nausea x5 days Narrative:
Vomiting, dizziness, pallor, headache a few minutes after shot of Hep A. Pt given ammous inhalant. BP, Pt lying down.
I had a low-grade temperature with chills after receiving my vaccine.  I would have periods time with these symptoms up to January or February 2022.  I would occasionally take Tylenol for the symptoms. I have routine doctor visits for my other illnesses and blood work which are within normal range. In July 2021, I started having heart palpitations that went on for an hour. I have been to many doctors, specialist, emergency rooms and hospital about this.  I take a beta blocker to help with the palpitations. In February 2022, I had heart stents which have helped me. Prior to the stents I was unable to sit upright because I could not breath. After the stents, I can function for about an hour to do normal life things. Then I have to sit down at a dragisic angle so I can breathe. After the last booster, my symptoms seem to be worse. As of today, I have the low-grade temperature with fever again.
Swollen, red, warm, sore at the site of the vaccine as well as declining 101 fever.