chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash on face; Feeling really very tired and felt like sleeping whole day; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8736) via an unspecified route of administration on 21Apr2021 (at the age of 35-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced rash on face and, feeling really very tired and felt like sleeping whole day in Apr2021. The outcome of events was unknown.   No follow-up attempts are needed. No further information is expected.
fussy 16APR93, hard to console, ate well 6-8oz, Friday noc; cried 16APR93 6PM-10PM awoke 11PM fussy again; pt seen in office DTP reaction; follow @ home;
Both lower arms and hands presented with red spots (approximately 5). Left hand became red and swollen for about 1 day.  Spots still present at time of report (7 days later)
9-year-old patient was inadvertently administered Adacel/no AE; Initial information received on 27-Aug-2020 regarding an unsolicited valid non-serious case received from a nurse.   This case involves a 9 years old patient who was inadvertently administered DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (batch number and expiry date not reported) via unknown route in unknown administration site on an unknown date for prophylactic vaccination (wrong product administered).  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to wrong vaccine administered   At the time of report no adverse event was reported.  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.  There will be no information available on batch number for this case.
10/7/20, about 2 weeks after receiving IM seasonal flu and Shingrex vaccine she developed back pain, numbness in legs which progressed to paraplegia over the course of around 6 hours.  MRI showed GAD enhancing partial transverse myelitis.  Treated with IV corticosteroid and over the course of 2 months she has improved quite a bit, walking without use of gait aid but remains incontinent of bowel and bladder and has disabling neuropathic pain.   CSF analysis,  MRI of the brain and repeat MRI of the cord shows that she does not have multiple sclerosis.  She was negative for the MOG and AQP4 antibody in serum.    she is diagnosed with transverse myelitis and this is suspected to have been triggered in some way by the vaccination.
Information has been received from a physician concerning a 2 month old patient who on 13-APR-2007 was vaccinated PO with the first 2.0 ml dose of ROTATEQ vaccine live (human-bovine). Concomitant vaccinations administered "at the same time included other 2 month vaccinations." Subsequently the patient developed diarrhea for 10 days and was hospitalized. Subsequently, the patient recovered. There was no product quality complaint. This is one of several reports from the same source. Additional information has been requested.
Patient experience localized swelling at injection site immediately after injection. Patient began to feel dizzy and lightheaded. I applied a cold pack to injection site for 15 minutes and observed the patient. Patient is currently feeling fine.
Red, swollen, irritated area. Vaccine was administered about 2 inches below ideal site.
Patient received an asymptomatic PCR test on 6/22/21 as a home care worker within home care system.  Patient tested COVID positive from that PCR test on 6/22/21. Patient fully vaccinated with Pfizer COVID19 vaccine received through system. Dose 1 on 12/30/20 and dose 2 on 1/20/21.
Fainted after shot administered, no actual LOC - felt dizzy and sat till felt better approximately 15-20 min. On way home from office developed slurred speech and numb tongue with worsening headache. Pt home tongue and speech improved, but developed worsening headache and vision problem. Headache lasted approximately 2-3 days off and on with vision problem slowly improving till pt felt normal approximately 3-4 days after event.
Fluvirin w/ Thimerosal given to OB pt. EDC = 3/19/2010. Pt does NOT have an OBGYN. Pt notified on 11/6/09. Denies any adverse effects. Pt NOT hospitalized after receiving H1N1 vaccine.  11/10/09 Medical records received for DOS 10/26/09.  IUP @21wks  w/pelvic pain. LMP 6/1/09. EDC 3/17/2010.
I had some diarrhea, headache and stuffy nose. I felt rundown to be safe I took a home COVID-19 test and so I set up a telehealth visit no prescription was given due to my mild symptoms.
Vaginal Yeast Infection; This is a spontaneous report from a contactable healthcare professional, the patient. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular in the right arm on 19Jan2021 at 20:15 (at the age of 42-years-old) at single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included multiple sclerosis. Concomitant medications were not reported. The patient had no known allergies. Prior to the vaccination, the patient had COVID-19 (date unknown). Lab test included Nasal Swab on 18Jan2021 was negative. On 21Jan2021, the patient experienced vaginal yeast infection. Treatment for the event vaginal yeast infection included miconazole (MONISTAST 3 day). The outcome of the event vaginal yeast infection was recovered in 2021.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
1 day after vaccine, nodule, red, and circular. Appeared below the deltoid muscle. Patient questioned if dose given too low. Vaccinator questioned and demonstrated when she administers and it was in proper location of deltoid muscle, referred patient to consult physician.
Experienced extreme weight loss and muscle atrophy starting in January 2022, ultimately leading to ALs diagnosis in November 2022.
This is a spontaneous report received report from a Pfizer sponsored program Pfizer First Connect. A 64-Year-Old male consumer reported that he received first dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation; solution for injection) via unspecified route of administration on 27Jan2021 as single dose for covid-19 immunization. On an unspecified date, patient experienced body pain. Therapeutic measures were taken which included Steroids and Tylenol prescribed from her family physician. The outcome of the event was unknown.  Follow up (29Jan2021): The initial case was missing the following minimum criteria: This case has been considered invalid as Other-info not qualifying for AE reporting- Medical Information. Upon receipt of follow-up information on 29Jan2021, this case now contains all required information to be considered valid. He received the 1st shot of our vaccine last 27Jan2021 and his doctor prescribed him to take Steroids and Tylenol for his body pain.  Information on Lot/Batch number has been requested.
Patient presented to the ED with 1 day history of chest and abdominal pain on 2/3/2022. States the pain lasts for around 30 minutes. The first 10 minutes described as 10/10 and then subsides to 3/10 over the course of 30 minutes. Pain located in the center of chest that radiates down to abdomen. Pain does not radiate to arms, back, or neck.  Does not feel the pain is related to movement or eating but it does get better when passing gas or burping. He vomited once yesterday morning, no diarrhea. Endorses pleuritic chest pain. He received his COVID-19 immunization 4 days ago, and has had headache and body ache since for which he has taken ibuprofen regularly.
Hospitalization for cardiac syncope; Dizziness; Hypotension; This is a spontaneous report from a contactable physician. A non-pregnant 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number and expiration date not provided) via an unspecified route of administration on 30Apr2021 (at the age of 64-year-old) as single dose for COVID-19 immunization. Medical history included coronary artery disease (CAD) and hypertension (HTN). No known drug allergies. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced hospitalization for cardiac syncope, dizziness, hypotension on 30Apr2021. The patient was hospitalized for all events for 2 days. The adverse events result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Patient received treatment for events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date.  Information about batch/lot number has been requested.; Sender's Comments: The events are assessed as possibly related to the suspect drug BNT162B2 based on strong temporal association but consider also possible contributory effects from patient's medical history and/or concomitant medications. 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.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Jan2021 at 15:00 as dose 1, single (Lot number: EL0140), in right arm, on 24Jan2021 at 12:00 as dose 2, single (Lot number: EL3246), in left arm and on 26Sep2021 at 11:00 as dose 3 (booster), single (Lot number: 30130BA) at the age of 40 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillins Allergy" (unspecified if ongoing); "asthma" (unspecified if ongoing). Concomitant medication(s) included: ALLEGRA, start date: 09Jun2022, stop date: 14Jun2022; MONTELUKAST, start date: 09Jun2022, stop date: 14Jun2022. Past drug history included: Cephalexin, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Jun2022 at 09:00, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Jun2022) Negative, notes: Rapid antigen test negative 3 days after completing paxlovid; (18Jun2022) Positive, notes: positive rapid antigen 4 days after completing course of paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Paxlovid was taken as treatment drug for COVID-19 Treatment from 09Jun2022 to 14Jun2022. On 18Jun2022 at 09:00 AM Nasal congestion, sneezing and positive rapid antigen 4 days after completing course of paxlovid. Rapid antigen test negative 3 days after completing paxlovid. Patient is currently recovering and no treatment was received. Vaccine was received. Yes, other medication was taken in 2 weeks.
Urticaria on the back of the left leg (Vaccine applied on the left shoulder), fever and swollen glands of left leg. According with the doctor the Urticaria is caused by an Herpes activated by the vaccine.  Treatment ACICLOVIR in cream and pills 400 MG and B complex DICLOFENACO.
pt recv vax 13MAY96 & 6JAN97 pt devel varicella w/approx 60 lesions;
ITCHINESS ALL OVER THE BODY; HEADACHES; FATIGUE; This spontaneous report received from a patient concerned a 42 year old male. 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 not reported, batch number: 1805025, and expiry: 25-MAY-2021) dose was not reported, administered on 08-MAR-2021 in right arm for prophylactic vaccination. No concomitant medications were reported.  On 08-MAR-2021, the subject experienced itchiness all over the body. On 08-MAR-2021, the subject experienced headaches. On 08-MAR-2021, the subject experienced fatigue. On 05-APR-2021, Laboratory data included: SARS-CoV-2 antibody test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headaches, fatigue, and itchiness all over the body. This report was non-serious.
Approx. 1 hr after receiving injection. Pt c/o itching to ears and chest, noted to have small/raised blanchable rash. MD notified. BENADRYL 50 mg PO given. No difficulty breathing or swelling of throat or mouth. 10/28 rash, itch gone.
Sore arm on day of vaccination (dose 1); This is a spontaneous report from a Non-contactable consumer (patient). A 63-Year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were not reported. The patient experienced sore arm on day of vaccination (dose 1) on 08Jan2021. The event happened on Friday, 08Jan the patient became aware on the evening of Friday, 08Jan. He reported the event on Saturday, 09Jan using the information he had received on the 8th (He did not receive further information on the 9th). The most recent COVID-19 vaccine was administered at Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No Covid prior vaccination. No Covid tested post vaccination. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Rush of heat throughout my upper extremities. Light-headedness.  Subsided after 30 minutes.  Lately, muscle weakness in left arm and legs.
accidentally administered expired Menactra to 4 patients with no reported adverse event; Initial information received on 04-Aug-2021 regarding an unsolicited valid non-serious case from a nurse via Global Media information (under reference 00710627).  This case involved 4 patients (unknown age and unknown gender) who accidentally received an expired dose of MENINGOCOCCAL VACCINE (MENACTRA) [expired product administered].  The past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patients received a 0.5 mL dose of suspect MENACTRA (lot U65218A, total, once and expiration date: 26-Jan-2021) via unknown route in an unknown administration site for prophylactic vaccination.  It was an actual medication error due to expired vaccine used (same day latency).  It was reported that "She said that they had read the expiration date wrong. She is looking for information on next steps. Outbound call placed on 04-Aug-2021 at 02:15 pm. the dates being entered into the system with the expiration date transposed with the year in the day spot and the day in the year spot. The caller reported that some of the patients recently received the expired Menactra and that at the time of this call the Patient Information and Administering physicians are unknown due to not having the information pulled up at the time of the call".  At the time of reporting, it was unknown whether the patients had any adverse event or not.  At time of reporting, the outcome was unknown for the reported event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
"Vaccine failure" (Haemophilus influenzae type B bacteremia onset 5 days p/vax);
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 5 (booster), single (Lot number: GH9702), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Known allergies: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid treatment.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300265205 same reporter/patient, different drug/event;
Very tired; Elevated kidney enzymes; Muscle breakdown/rhabdomyolysis/his numbers were 1 million then dropped to 80, 000/muscle proteins were breaking down and going into his kidneys; Elevated liver or kidney enzymes; This spontaneous case was reported by a consumer and describes the occurrence of RHABDOMYOLYSIS (Muscle breakdown/rhabdomyolysis/his numbers were 1 million then dropped to 80, 000/muscle proteins were breaking down and going into his kidneys), HEPATIC ENZYME INCREASED (Elevated liver or kidney enzymes), FATIGUE (Very tired) and ENZYME LEVEL INCREASED (Elevated kidney enzymes) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced RHABDOMYOLYSIS (Muscle breakdown/rhabdomyolysis/his numbers were 1 million then dropped to 80, 000/muscle proteins were breaking down and going into his kidneys) (seriousness criteria hospitalization and medically significant), HEPATIC ENZYME INCREASED (Elevated liver or kidney enzymes) (seriousness criterion hospitalization) and ENZYME LEVEL INCREASED (Elevated kidney enzymes) (seriousness criterion hospitalization). On an unknown date, the patient experienced FATIGUE (Very tired) (seriousness criterion hospitalization). In 2021, RHABDOMYOLYSIS (Muscle breakdown/rhabdomyolysis/his numbers were 1 million then dropped to 80, 000/muscle proteins were breaking down and going into his kidneys), HEPATIC ENZYME INCREASED (Elevated liver or kidney enzymes) and ENZYME LEVEL INCREASED (Elevated kidney enzymes) had resolved. At the time of the report, FATIGUE (Very tired) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.  This case concerns a 27-year-old male patient with no relevant medical history, who experienced the unexpected events of Rhabdomyolysis, Hepatic Enzyme Increased and Enzyme Level Increased. The events, which caused hospitalization for the patient, occurred on an unknown date after receiving an undisclosed dose number of mRNA-1273 Vaccine. The rechallenge was not applicable since no dose number was disclosed. No hospitalization details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 27-year-old male patient with no relevant medical history, who experienced the unexpected events of Rhabdomyolysis, Hepatic Enzyme Increased and Enzyme Level Increased. The events, which caused hospitalization for the patient, occurred on an unknown date after receiving an undisclosed dose number of mRNA-1273 Vaccine. The rechallenge was not applicable since no dose number was disclosed. No hospitalization details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Vaccine administered after after 4 temperature excursions; Vaccine administered after after 4 temperature excursions; No aderse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No aderse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions).    No concomitant medications were reported.   It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that vaccine was moved from freezer to refrigerator on 12/2/22 of the ten vials in question 43 injections were given and 7 doses were wasted. Vaccine administered after after 4 temperature excursions.  No treatment medication was provided.  This case contains information for the 13th of 43 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-689222 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-Dec-2022: Upon internal review on 20-Jan-2023, significant correction was performed to update the worldwide unique case identification number.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689222:Master
severe headache with meningeal signs, lasted 4 days while treated with high dose prednisone, then subsided, still on tapering med dose