chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On the morning of February 24,2022  I went to get some blood work. I also had a doctors appointment at about  3pm of that morning. Upon leaving the doctors office, I was called back Via cell phone, and Via cell phone to my wife, saying they wanted to talk to me about my Platelets, So i went back to the doctors office and was shown my blood draw results. I saw my Platelets at ( TWO). Platelets have to be between 150,000-- 450,000. I was told that I could end up with blood clots and to go to the emergency room, So My DR called my employer  and I was admitted to the emergency room where I was A patient for 3 nights and 1 day. Prior to that I noticed rashes on my inner thighs, Nose bleeds and bleeding from my mouth. When I was seen In the ER A Doctor came in and asked me some questions and all questions and answers lead the Dr to believe the Covid ( Maderna ) Booster which caused the platelets to drop. Two time ( Two sets of blood draw one on 11/04/21 ( 291 )  and 2/07/22 ( 219 (.
08/05/2021 The patient presents with episodic chest pain. The pt had the first of these episodes at 0700 after a stressful situation. She had chest tightness with sweaty palms and sensation of stabbing pains in multiple areas of the body including in both knees. These episodes lasted 40 minutes before resolving. Then again at 1900 tonight she had another episode of the same. This episode lasted until the pt arrived in the ED.
Atopic dermatitis after the injection of Pfizer Covid Vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): us_-017025-PV.  A 71-year-old male 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: DERMATITIS ATOPIC (non-serious), outcome "not recovered", described as "Atopic dermatitis after the injection of Pfizer Covid Vaccine".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Reddened area where shot was given, blister like. Child irritated it by picking and rubbing it causing it to get deeper and larger. Size of a nickel pen wound, red x 1 week.
pt devel vomiting following vax w/Hep B vax; vomiting lasted for 1 evening; It was thought that the pt's exp may have been related to the flu; No further details were provided;
Patient was given adult strength Pfizer covid vaccine at 0.2ml pediatric dose.  Patient parent was informed after we got notification from Immunization Information System. Patient parent was informed no repeat or additional vaccine shots is needed.
Refrigerator containing Fluzone went down to 29.1F. After that excursion, vaccine administered to patient / no AE; Initial information received on 07-Feb-2020 regarding an unsolicited valid non-serious case received from an other health professional.  This case is linked to cases 2020SA032577, 2020SA038302, 2020SA032577, 2020SA038344, 2020SA038467, 2020SA038474, 2020SA038473, 2020SA038466, 2020SA038472, 2020SA038471, 2020SA038470, 2020SA038469, 2020SA038468, 2020SA038351, 2020SA038348, 2020SA038349, 2020SA038345, 2020SA038346, 2020SA038347, 2020SA038350 and 2020SA038352.  This case involves a four months old female patient who 0.5 ml dose of  IPV (VERO) [IPOL] (lot PIF541M, exp date: 07-DEC-2020) via unknown route in the right thigh for prophylactic vaccination on 15-Jan-2020.   Medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation; HEPATITIS B VACCINE (HEPATITIS B VACCIN) for Immunisation; HIB VACCINE (HIB) for Immunisation; PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  It was an actual medication error case due to Product storage error temperature too low.  It was reported that refrigerator containing Fluzone went down to 29.1F and the vaccine was given to the patient in spite of being compromised.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder 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.
SORE ARM; This spontaneous report received from a patient 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, and batch number were not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm. This report was non-serious.
All of us started experiencing headaches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "recovering", described as "All of us started experiencing headaches". Therapeutic measures were taken as a result of headache. No follow-up attempts are possible. No further information is expected.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (08Nov2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
now she has flu symptoms/I have the flu now I don't know its flu or not; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administration date 03Dec2021 (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: INFLUENZA (non-serious) with onset Dec2021, outcome "unknown", described as "now she has flu symptoms/I have the flu now I don't know its flu or not". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No additional AEs; HCP calling in to report that an expired dose of PNEUMOVAX 23 was administered on 11/10/2022.; This spontaneous report was received from registered nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 10-NOV-2022, the patient was vaccinated with expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot# U00306 has been verified to be not valid lot number, expiration date reported as 15-OCT-2022 (Expired product administered ) for prophylaxis (dose, route of administration and anatomical location were not provided). No additional adverse events was reported.
Administered expired vaccine to patients/ Dose administered after 30-day use by date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patients/ Dose administered after 30-day use by date or after manufacturer date of expiry) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patients/ Dose administered after 30-day use by date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patients/ Dose administered after 30-day use by date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided  The vial did not undergo any temperature excursions Total of 168 doses were given from LOT 048C21A It was reported that the date vial initially stored in refrigerator was unknown  Treatment medication was not provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non Significant  follow up was received
Face, Neck, Lips,  Tongue went numb for 1.5 hours.
fever 102.5 degrees (Sat 3/27); fever 100 (Sun 3/28); temperature dropped into 96-96.6 range (Tues ) and I felt weak/shaky/faint; extreme fatigue (4 days); weakness (4 days); body aches (2 days); joint aches (right shoulder; left hand); "Covid arm" - pain; hard lump; rash in circular pattern around injection side (lasted 4 days); high blood pressure (145/90; no previous history) - ongoing; fatigue and lack of energy (ongoing)
HEADACHE; TIRED; This spontaneous report received from a patient concerned a female of unspecified age. 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: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced headache, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and tired was not reported. This report was non-serious. This case, from the same reporter is linked to 20210728583.
From initial information received on 22/Sep/2003 from manufacturer (HQWYE969108AUG03), regarding an adverse event occurring in the US, it was reported that a 16-month-old male patient received a dose of ACTHIB, lot number UA722AA/ french lot number U1429-2 (route/site not reported) on 15/Apr/2003. The same day, the patient developed a high fever and experienced a seizure. Reportedly, the patient recovered from these events. From additional information received on 29/Sep/2003, from a health care professional from the reporting physician's office, it was reported that on 15/Apr/2003, the patient received his fourth dose of ACTHIB, lot number UA742AA/W0021-2 (France lot number, previously reported as UA722AA / U1429-2), given intra-muscularly in the left thigh, first dose of MMR, lot number 0524M, given subcutaneously in the left thigh, first dose of Varicella, lot number 0327M, given subcutaneously in the right thigh and third dose of PCV-7, lot number 491-190, given intra-muscularly in the right thigh. The patient has a history of congenital heart disease of ventricular septum defect, that was corrected at nine months of age. No further information is anticipated, this case is considered closed.
pt report ball in throat and cold in throat, did not progress. kept for 30 min post shot. no vocal changes, no changes in breathing. Assessed by NP and d/c'ed home.
Patient developed a fever of 102.7 and redness, swelling and warmth at injection site.
Patient is a 59 y.o. male with PMHx significant for ESRD, type 2 diabetes mellitus, hypertension, OSA who presented with altered mental status via EMS status post dialysis.  Patient desaturated initially and was escalated to BiPAP, reported to have required intubation. The patient was admitted to the Critical Care service for Ventilator management. Patient's mentation has dramatically improved and patient was extubated on 10/09 around noon without issue Consulted by ICU Team for Transfer of care.    Acute on chronic respiratory failure with hypoxia and hypercapnia Secondary to volume overload, COVID Of note, pt was set up for home oxygen last admission (qualified for 2 L NC ATC) but refused DME delivery at home since he wanted a smaller tank Intubated on admission now extubated and requiring 2 L NC with ambulation Will try to set up Home oxygen again this admission   Covid-19 Virus Infection Date of onset of symptoms: 10/8/2022 Symptoms present on admission: hypoxia, weakness Date of covid positive test: 10/9/2022 Vaccination status: vaccinated Imaging: CT pulmonary arteries without PE and with Improved aeration of the lung bases with some residual atelectasis.   Oxygen requirements on admission: Intubated on admission Current oxygen requirements: 2 L NC with ambulation Medical therapy: dexamethasone until 10/19, covid cocktail Consultants following: none  Anticipated special isolation end date: 10/17/2022    Septic shock AF, wbc 3.7, UA without infection, CXR with overload MRSA probe +, Urine ag negative, Blood culture NGTD Required Levophed for a short time IV vancomycin and cefepime started on admission, now stopped PCT is stable at 0.7   ESRD on HD usually TTS Volume overload Hyperkalemia Nephrology following; RUE AVF HD x 3; labs and symptoms improved Pt declined HD today   Acute metabolic encephalopathy Likely secondary to CO2 narcosis from COVID and volume overload CTA showed no evidence of acute vessel occlusion no evidence of high-grade stenosis within the proximal large vessels.  Atherosclerotic plaque visualized in the bilateral carotid bifurcations with less than 50% stenosis; Moderate to marked occluders disease noted along the aortic arch with hypodense plaque noted along the periphery. Patient back to baseline Bilateral carotid stenosis CTA showed atherosclerotic plaque visualized in the bilateral carotid bifurcations with less than 50% stenosis OP monitoring   Thrombocytopenia Chronic, stable, asymptomatic   Elevated troponin Troponin 75-- >72 Likely combination of ESRD, septic shock Patient denies any chest pain
I got dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (I got dizzy) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 DIZZINESS (I got dizzy). At the time of the report, DIZZINESS (I got dizzy) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-231505.   Reporter did not allow further contact
patient inadvertently received 2nd dose of PNEUMOVAX 23 approximately 1 year from the original dose; This spontaneous report was received from a physician assistant and a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.    On an unspecified date approximately in 2019, patient received the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis. Then, the patient went to the clinic and stated the need for pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23); therefore, they received, inadvertently, on 18-AUG-2020, the second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis, but it was approximately 1 year from the original dose. Reporter stated that pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was administered and later was found in the record that the patient received the first administration of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) approximately 1 year ago.
Child was given varicella vaccine on 01-27-03. Child was seen by Dr. on 02-17-03 "covered with chicken pox". Dr. called health Department and insisted we fill out a VAERS form.
Information has been received from a physician concerning a 60 year old female who on approximately 06-Nov-2006 was vaccinated SC with a 0.65 ml dose of varicella-zoster virus vaccine live (lot#652936/0981F). After vaccination, on approximately 06-Nov-2006, the patient developed an atypical shingles rash with pain. Unspecified medical attention was sought and the patient was treated with gabapentin (NEUROTIN) for the pain. At the time of the report, the patient was recovering. A product quality complaint was not involved. Additional information has been requested.
felt like she had a stroke; fell down; Pain in leg; itchiness in her head; left leg not functioning normally; This is a spontaneous report from a contactable nurse (reporting for herself).  A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EH9899), via an unspecified route of administration in the left deltoid on 21Dec2020 at 10:00 (at the age of 51-years-old) as a single dose for COVID-19 immunization.  Medical history was none.  There were no concomitant medications. There were no prior vaccinations within 4 weeks prior to the first administration of the suspect vaccine.  On 21Dec2020, the patient experienced left leg not functioning normally, which was reported with the seriousness criteria of disability.  On 21Dec2020, the patient had itchiness in her head.  The patient felt like she had a stroke, fell down and pain in leg on 22Dec2020, which were all reported with the seriousness criteria of disability.  The patient called the doctor office and spoke with the doctor on call and was told to use diphenhydramine hydrochloride (BENADRYL). No further details provided. The patient was sent home for 10 days and she was sent back to work. The patient underwent lab tests and procedures which included COVID: negative in Dec2020.  The outcome of the events was not recovered.  The reported assessed the events related to the suspect product, BNT162B2.; Sender's Comments: The reported events leg dragging, leg pain and fall and suspected stroke were possibly related to the use of first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship.  However, stroke was not diagnosed. The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product 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.
Refridgeration excursions identified; No adverse event; Poor quality product administered; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event) in a 76-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Sep-2022 at 2:58 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 15-Sep-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) and PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified).    No concomitant product reported by the reporter. Dose 4 anatomical site was reported as deltoid. It was reported that the vaccines had undergone several temperature excursions in August 2022. Refrigeration excursions identified and vaccine was housed in the units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation. No adverse reactions reported for any patient at the time of report.  It was unknown whether patient has diagnosed/tested positive for COVID-19. It was reported that 0.5 volume of vaccine was taken with unknown units. No treatment medication reported by the reporter.
Left Chest Pain, pain feels worse when i took a deep breathe, headache, fatigue, chills, chest feels pressure when laying down
No adverse reaction. Possible Misadministered vaccine. TDaP instead of DTaP.
Pt received her 2nd dose of the Pfizer vaccine and was waiting her 15 minutes post-vaccine in the waiting area. I responded to people saying "help help." She had slid out of her chair and fell to the floor. Her mom said that she postured (head tilted back) very quickly. When I got to her, her eyes were open, she was breathing. We called the ambulance right away and they were already on their way. I asked her questions to make sure she was alert. Asked her what day it was, her name, birthday, her daughters name and she answered it all correctly. She laid down until the emt showed up and they took over after. No CPR or medications were administered from Pharmacy end. They took her to the hospital.
WHOLE SIDE HURT; THE ARM GOT THE SHOT HURT REALLY BAD; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. 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 experienced whole side hurt, and the arm got the shot hurt really bad. Laboratory data (dates unspecified) included: COVID-19 virus test Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from whole side hurt, and the arm got the shot hurt really bad. This report was non-serious.