chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she got her vaccine it affects her platelet; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PLATELET DISORDER (non-serious), outcome "unknown", described as "she got her vaccine it affects her platelet". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient stated that when she got vaccine it affected her platelet, she was not able to get any type of the vaccine and Pfizer never admit it and never dismissed the seriousness of it and added that the vaccine is stay and fall safe.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sudden onset of dizziness.  Patient reported a hx of diabetes,  he had not eaten before the injection.  Nurse gave patient juice and crackers, and encouraged patient to take slow breaths.  Serial vitals were taken.  Dizziness resolved within 10 minutes.  Patient ambulated out of the clinic with even and steady gait.
This spontaneous report was received from a healthcare worker refers to unspecified number of unspecified patients of unknown gender and age. Information regarding patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L043213, expiry date: 28-AUG-2017 and lot # M005714, expiry date: 03-OCT-2017) via intramuscular route. No adverse effects were reported. Additional information has been requested.
Development of Left sided BELL'S PALSY within hours of the HPV vaccine (1st dose).
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Pertinent medical history was unknown. On 30-JAN-2015 the patient was vaccinated with GARDASIL (intramuscular, dose and anatomical location was unknown) which had expired on 09-JAN-2015 (Expired product administered). Concomitant medications were unspecified by reporter. No adverse effect reported. The outcome of the events was unknown. Additional information has been requested.
Information has been received from a physician referring to an unknown number of patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, on or after 01-APR-2016, the patients were vaccinated with improperly stored doses of VARIVAX (lot # L024253 with expiration date 01-JUL-2017, lot # L024256 with expiration date 01-JUL-2017, lot # L001328 with expiration date 13-JAN-2017, lot # L016123 with expiration date 06-MAY-2017; dose and route were not reported). It was reported that the vaccine was improperly stored at 35.47 Fahrenheit for 314 hours and 15 minutes. There was no previous excursion and data logger was involved. No adverse effect was reported. This is one of two reports received from the same reporter. Follow up information has been received from the physician on 24-OCT-2016. On 24-OCT-2016, a call was placed to the physician. The call was received by another physician. The physician reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. The correspondence details were reviewed with the physician, if information becomes available. Follow-up information was received on 09-NOV-2016 from an unspecified reporter, who provided the patient's demographics, and stated that the patient (of unknown age and gender) was vaccinated with an improperly stored dose of VARIVAX with lot number L001328 (expiration date 13-JAN-2017). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information is not expected, as follow ups requested to complete the case were received.
p/vax pt MD Dx erythema nodosum on bilateral lower legs; tx: w/hydrocortisone cream & naprosyn
Vaccine given 1105 am 8/2/11, child anxious, worried about pain, about 1 minute later had syncope, pallor, vasovagal type rx - laid on exam table, legs elevated. BP 119/82, HR 50, assessed by MD ambulance called 911 - to ER - disch at 1:15pm.
I first started feeling dizziness and light headedness. The top portion of my body started to feel numb. After about 5 minutes, I started feeling better. Then I started getting nausea and stomach pain. My lips started turning numb and purplish. Once I got to the ER  (Hospital) building, I was having really bad chest pain. My nausea was getting worse. My stomach was hurting really badly on both sides. I lips started drooping. My lips were going numb and my face felt numb. They thought I was having a seizure. My eyes started to feel smaller and smaller. I couldn't really see anything anymore. My heart was beating very fast, but I have a pace maker and it was not set up for that. My heart rate was too high. The doctor had a hard time keeping up with me. My legs started feeling shaky. I was very cold even though I was covered with blankets. I was shivering. They took blood for lab work. When they sent me home, I could not walk or stand and I was dizzy for about 3 days. I felt like I could barely see anything. I was afraid to be alone. I felt like if I were to stand up, I was going to fall. I couldn't eat anything because when I did my stomach would hurt really bad. They prescribed me a pill to take at home and we couldn't find that medicine anywhere. For the first few weeks, I couldn't eat anything. I had chest pain. My oxygen levels were going lower and lower. My leg was still hurting at home. My head was constantly hurting. They thought it might have been because of my artificial wall in my heart. I don't remember what all tests they did at the ER. I still feel like I get some leg pain. My arm is still a little sore every now and then like it was when I got my vaccine.
vaccination failure; mumps parotitis; This literature marketed report has been received from authors of published article. The incidence of parotitis and mumps in children was increasing nationwide. Retrospective chart reviews were conducted using ICD9/10-codes for parotitis and mumps from January 2007 to December 2017. Data on demographics, vaccination status, labs, management and disposition were collected. The patients had mumps immunoglobulin (IgM) and/or buccal swab for mumps reverse transcription polymerase chain reaction (RT-PCR) or viral culture to test mumps. 1017 parotitis cases were diagnosed, an upward trend in incidence occurred over time. Of the 1017 children with parotitis evaluated over the decade in the Healthcare emergency departments (EDs), 47 (4.6%) were tested for mumps and 9 (19%) of those tested were positive for mumps either by serology and/or PCR. Five of those cases were considered probable mumps and 4 were confirmed mumps. Of the 9 patients identified with probable or confirmed mumps, 7 (78%) were fully immunized, one was incompletely immunized (one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown)) and 1 child was unvaccinated. The most likely explanation for mumps cases in previously immunized persons may be secondary vaccine failure, or waning immunity.  This report referring to a 13 years old male patient. Information about concurrent condition, concomitant medication and medical history was not provided.  On unknown dates, the patient was vaccinated with two doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) for prophylaxis (strength, dose detial, route, lot #, expiration date and anatomical location were not provided).   In 2017, the patient was tested mumps IgM and RT-PCR at buccal. The results were postive for mumps at bilateral buccal. It was considered probable mumps parotitis. The patient had fever with body temperature more than 38 degree Celsius. On an unknown date, the patient experienced vaccination failure. The outcome of the events was unknown. The reporter considered the events to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown).  This is one of several reports received from the same literature.; Sender's Comments:  US-009507513-2011USA009173:
Chills, sweats, fever 102.5+ for about 18 hours, body aches/pains (including bottoms of feet and palms of hands), headaches, nausea.
Headache, Myalgia, NauseaVomiting, SWOLLEN AND BLOODY EYES Narrative:
On ALS exam pt alert, oriented. Pt states he has a history of passing out after getting a needle or having blood taken. Pt rcv'd J&J vaccine, and once in the monitoring area, he became lightheaded. Pt pale w/ thready radial pulse palpated on initial ALS contact. Pt placed seatback in reclined position and elevated feet on dashboard. Radial pulse strong on palpation. Pt symptoms subsided, color improved. V/S as shown. Pt returned seatback to upright position, and remained without complaint. Pt states he feels much better now. Pt exits vehicle and enters front passenger seat as his companion was going to drive home.
No additional AE reported.; A nurse reported V ARlV AX was improperly stored and administered.; This spontaneous report was received from a licensed practical nurse, referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.   On unspecified dates, the patients were vaccinated with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot number T017686 which has been verified to be valid, expiration date reported and validated as 21-MAY-2022) (lot number T017682 which has been verified to be valid, expiration date reported and validated as 21-MAY-2022) (doses and frequencies were unknown by the reporter; vaccination schemes, routes of administration, and anatomical site of injection were not reported) as prophylaxis. The administered doses of the vaccine were stored on 19-JAN-2021, at a temperature of 9.1 degrees Fahrenheit (F), during a time frame of 2 hours, as recorded by a digital data logger. There were previous temperature excursions reported on 02-DEC-2020, 6 F to 14 F (11 F) during a time frame of 1 hour, and 14 F to 46 F (36F) during a time frame of 3 hours. On 14-DEC-2020, 6 F to 14 F (13.8 F) during a time frame of 6 hours, and 14 F to 46 F (15.8) during a time frame of 42 minutes. On 21-DEC-2020, 6 F to 14 F (8.8 F) during a time frame of 1 hour and 30 minutes. On 07-JAN-2021, 6 F to 14 F (9.5 F) during a time frame of 10 hours. On 18-JAN-2021, 14 F to 46 F (32.4 F) during a time frame of 5 hours 0 minutes and 0 seconds. No additional adverse events were reported in the patients.  This is a non-valid case due to the lack of patient identifiers.  Follow up information was received from the  licensed practical nurse on 28-JAN-2021 regarding a 1 year old female patient. with 2 siblings, birth weight of 4.7 lb. Her concomitant therapies included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), hepatitis a virus vaccine inactivated(HAVRIX) and pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197)(PREVNAR). The patient's concurrent conditions and medical history were not provided.   Since 02-DEC-2020, the varicella virus vaccine live (oka/merck)(VARIVAX) experienced temperature excursions with a total of 29.5h.    On 14-JAN-2021, the patient was vaccinated with her first dose of this improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot# T017686, expiration date 21-MAY-2022, subcutaneously in the left thigh, for prophylaxis, on a private doctor's office/hospital with public funds.  This is one of several reports from the same reporter (US-009507513-2102USA002533,US-009507513-2102USA002536,US-009507513-2102USA002535,US-009507513-2102USA002534 and US-009507513-2102USA002537).; Sender's Comments:  US-009507513-2102USA002533: US-009507513-2102USA002536: US-009507513-2102USA002535: US-009507513-2102USA002534: US-009507513-2102USA002537:
Patient reported joint, knee and shoulder pain that is still ongoing as of 02/24/2022.
Three days following vaccination, patient developed maculopapular lesions on ankles, thighs, back, and arms. They are accompanied by itching skin and achy muscles. Initial treatment is triamcinolone 0.1% cream.
in 24 hours fever weakness fatigue nnasea vomiting headache now thing encephalitis. In hospital 2 days dehydrated IV fluids, pain med anti nausea and now 9 day course of predisone.
fatigue/ feeling tired; really bad anxiety; achy; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient (reported as patient's age: 66; unit: unspecified) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 03Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "fatigue/ feeling tired "; ANXIETY (non-serious) with onset Mar2021, outcome "unknown", described as "really bad anxiety"; PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "achy".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB06AA, expiry date 20th March 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st April 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 21st April 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was 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: 21-APR-2022 Reporter's Comments: The registered nurse reported that the  patient received an expired dose of Bexsero. The reporter did not consent to follow-up. Additional Supportive Information: The patient received vaccine which was already expired which led to expired vaccine used.
Pfizer-BioNTech COVID-19 Vaccine EUA I've had a slight headache above my right eye  since the day after vaccine (3/6/21).
GASTROINTESTINAL SYMPTOMS (GI); UPSET STOMACH; This spontaneous report received from a pharmacist 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced gastrointestinal symptoms (gi), and upset stomach. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from gastrointestinal symptoms (gi), and upset stomach. This report was non-serious.
He has only had one minor flare up (shortly after the second vaccine); His symptoms (rash, pain, raw skin) have been gone since about 2 weeks after his second dose.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "fungoides mycosis lymphoma", start date: Jan2021 (unspecified if ongoing), notes: He had symptoms for 4 plus years, had numerous biopsies, and had seen many doctors.; "numerous biopsies" (unspecified if ongoing); "rash" (unspecified if ongoing); "pain" (unspecified if ongoing); "raw skin" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization. The following information was reported: CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "He has only had one minor flare up (shortly after the second vaccine)"; THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "His symptoms (rash, pain, raw skin) have been gone since about 2 weeks after his second dose".  Additional information: The daughter of the patient reported that her father has been diagnosed with fungoides mycosis lymphoma. He has had symptoms for 4+years, had numerous biopsies, and seen many doctors. He was given the diagnosis in January of 2021. He was ready to start a treatment (a chemotherapy topical cream), however, after his second dose of your vaccine, he has only had one minor flare up (shortly after the second vaccine). His symptoms (rash, pain, raw skin) have been gone since about 2 weeks after his second dose. He contacted Pfizer and they transferred him to the FDA, but they were only concerned about adverse reactions. She wanted to inform in case the cessation of his symptoms were not just a coincidence. Her father's condition had been persistent, and he has been documenting it with photos over the years. He continues to document his newly clear skin every couple of days. This may be just a coincidence, or it could be a great thing!  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Injection site arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site arm was sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Injection site arm was sore). At the time of the report, VACCINATION SITE PAIN (Injection site arm was sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-077602 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-077602:Crosslinked with daughter's case (MOD21-076473)
Breakthrough case admission after 2 vaccines Pfizer 1/26/21 Lot# El3248;  Pfizer 2/16/21 lot# EL3249
ADACEL at a low of negative 5.1C out of range for 12 minutes and a low of 1.3C out of range for 10 minutes and was administrated post excursion with no reported adverse event; ADACEL at a low of negative 5.1C out of range for 12 minutes and a low of 1.3C out of range for 10 minutes and was administrated post excursion with no reported adverse event; Initial information received on 06-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional.   This case is linked to cases 2022SA370866(CLUSTER), 2022SA372086(CLUSTER), 2022SA372581(CLUSTER), 2022SA372080(CLUSTER), 2022SA372584(CLUSTER), 2022SA373534(CLUSTER), 2022SA371564(CLUSTER), 2022SA371948(CLUSTER), 2022SA372095(CLUSTER), 2022SA372123(CLUSTER), 2022SA372180(CLUSTER), 2022SA371333(CLUSTER), 2022SA372199(CLUSTER), 2022SA373167(CLUSTER) and 2022SA373167(CLUSTER).  This case involves a 79 years old female patient who was administrated DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] post excursion at a low of negative 5.1 C (Celsius) out of range for 12 minutes and a low of 1.3C out of range for 10 minutes and with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 30-Aug-2022, the patient received 0.5 ml, total dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE, unknown formulation (lot U7461A, exp date: 12-Jul-2024)  via intramuscular route in the left arm as Immunization.  On an unknown date the DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE at a low of negative 5.1C out of range for 12 minutes and a low of 1.3C out of range for 10 minutes (product storage error) and was administrated post excursion on 30-Aug-2022 with no reported adverse event (poor quality product administered) (latency: same day.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the events.   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.; Sender's Comments:  US-SA-2022SA372080:
Discovered that client rec'd vaccine at age 17 - EUA is for 18 +
Patient received the 2nd COVID vaccine Moderna Lot #011F21A, expiration date 11-06-2021 at 12:33PM.  PHN administered vaccine and upon vaccination observed vaccine leaking from syringe HUB.  PHN completed vaccination but was unable to retract syringe.  PHN  was unable to determine the amount of vaccine administered to patient. PHN  notified PHN  who then notified Clinical Educator .  Clinical Educator notified PHN to complete Incident Report and VARES.  Patient verbalized no concerns  or questions regarding efficacy and was confident with receiving 2nd dose.
felt really bad; Initial information received on 18-Oct-2023 regarding an unsolicited valid Social Media non-serious case received from a Patient.  This case involves an unknown age and unknown gender patient who experienced felt really bad after 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, strength, expiry date, dose not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date the patient developed felt really bad (feeling abnormal) (unknown latency) following the administration of Influenza Vaccine.  It was reported "I felt really bad afterwards ,that's why I wont let them do it anymore."  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Patient was scared of needle and stated he would pass out. He passed out after 5 minutes receiving the shot. Gained consciousness shortly about 40 seconds and he was fine.
Yes re by the evening of 5/20/2010 then later turned into a rash.
Patient presented to the ED and was subsequently hospitalized for small bowel obstruction within 6 weeks of receiving COVID vaccination.
Received vaccine on 9/4, noted redness and irritation on the 7th. Pt reported no itching or pain.
SkinRash, Rash, Employee exhibiting hives as of 1/12/2021