chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; The patient received first dose on 17-Feb-2021 and second dose on 13-Feb-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received first dose on 17-Feb-2021 and second dose on 13-Feb-2022) and NO ADVERSE EVENT (No adverse event) in an 81-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 025L21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Feb-2022, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 13-Feb-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received first dose on 17-Feb-2021 and second dose on 13-Feb-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received first dose on 17-Feb-2021 and second dose on 13-Feb-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received first dose on 17-Feb-2021 and second dose on 13-Feb-2022).    It was unknown that the patient ever been diagnosed with or tested positive for COVID-19.   Concomitant medication information was not provided.  On 17-Feb-2021, the patient received first dose of Moderna COVID-19 vaccine, Intramuscular route with batch lot number: 010M20A.    The dose details of first and second dose was reported as 0.5.  Treatment information was not reported.   This case was linked to MOD-2023-722262 (Patient Link).
Inappropriate schedule of vaccine; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old male patient who received DTPa-IPV (Kinrix) (batch number 3KS4F, expiry date 22nd March 2024) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Pediarix (an unknown date received 2 doses).   On 4th October 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 4th October 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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: 07-NOV-2022 Reporter's Comment: The LPN reported that child received Kinrix vaccine after receiving 2 doses of Pediarix and prior to 4th birthday.  The patient was 3 years 11 months 8 days at administration. The reporter consent to follow up. Additional Supportive Information: 3 years 11 months 8 days old patient received Kinrix, which led to inappropriate age at vaccine administration.
sepsis; A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 3 STUDY TO ASSESS THE EFFICACY AND SAFETY OF AD26.COV2.S FOR THE PREVENTION OF SARS-COV-2-MEDIATED COVID-19 IN ADULTS AGED 18 YEARS AND OLDER  This is a Non-Pfizer sponsored interventional study report, based on information received by Pfizer from Janssen Vaccines & Prevention B.V. (manufacturer report number USA-U38-US10051-2021-VAC31518COV3009000010 (0)).   A 52-year-old male subject received blinded therapy (Ad26.COV2.S /Placebo) on unspecified date. The subject also received Pfizer COVID-19 vaccine (BNT162B2), intramuscularly, first dose on unspecified date and second dose on 17Apr2021. The subject's medical history was not reported. Concomitant medications included alprazolam from 01Jan2015 for anxiety, rosuvastatin from 01Jan2018 for high cholesterol, and lisinopril from 01Jan2018 for high blood pressure. The subject experienced sepsis on 18Apr2021, which was considered as life-threatening event and required hospitalization. Clinical course was as follows: subject's wife called site on 26Apr2021 to report that subject had not been feeling well since 18Apr2021, one day after receiving second dose of Pfizer COVID-19 vaccine. He was having body aches and fatigue. Since symptoms were getting worst, subject decided to go to hospital on 22Apr2021. He was admitted and informed he had sepsis. Subject continued being in the hospital. Sepsis adverse event toxicity was grade 4. Relevant tests were not reported. The action taken in response to the event for blinded therapy and for BNT162B2 was not applicable. The outcome of the event was recovering.  The investigator considered there was not a reasonable possibility that the event sepsis was related to blinded therapy; however, the investigator assessment of the causal relationship of the event sepsis with the product BNT162B2 was not provided at the time of this report. Efforts are being made to obtain such final determination. Since no determination has been received, the case is managed as if the investigator's assessment was that a reasonable possibility exists that the event was related to BNT162B2, as a cautionary measure and for reporting purposes.; Sender's Comments: Based on the information currently provided, the company considers there is not a reasonable possibility that the event sepsis is related to Pfizer COVID-19 vaccine (BNT162B2) and Non Pfizer blinded therapy due to the lack of a plausible pathophysiological mechanism.   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
VERY DIZZY; HAVING A VERY LIGHT BUZZING SOUND IN MY HEAD THAT COMES AND GOES; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9269), via an unspecified route of administration in the left arm on 01Mar2021 at 11:00 (at the age of 66-year-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer (20-year survivor). The patient had allergies to penicillin, aspirin, codine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included pravastatin (MANUFACTURER UNKNOWN) 40mg, citalopram hydrobromide (MANUFACTURER UNKNOWN) 20 mg for unknown indication from unknown date. On 23Mar2021, patient experienced very dizzy for 3 days, very light buzzing sound in head that comes and goes. 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 events very dizzy, very light buzzing sound was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient's significant other brought him into the hospital because of severe headache and right-sided numbness. Patient had been feeling numb from the right mid forearm distally and from the lower third of the right leg distally since yesterday at 4:30pm. The numbness is described as constant, with no relieving factors, no exacerbating factors. He has waning and waxing episodes. He had difficulty walking because of losing balance today. He has had headache for 2 days, the headache is constant, better with the sumatriptan, exacerbated with loud noises, non-progressive, 10 out of 10 pain level when he came to the ED. Pressure and throbbing-like in nature and localized on the right side of the head. Patient's significant other states that yesterday at approx 5:30pm, she heard a thud sound in the kitchen and found patient lying on the floor responsive. Patient says they opened the refrigerator  and then next thing they knew, they woke up lying on the floor. He has been having exertional dyspnea since yesterday. He has been feeling more warm than usual for 1 week but did not check his temperature at home. He has been having chills and shivers from time to time over the past week. He feels dizzy while standing up. He has generalized weakness. He lost 8 lbs unintentionally in the past month.
Pt was accidentally given a PEDRIAX injection and a Hepatitis B injection instead of a PENTACEL and Hepatitis B injection.
Diffuse large b cell non Hodgkin's lymphoma 22Jul2022.; Heart pericardial effusion 16Jul2022 fluid treated positive for lymphoma.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2022 as dose 3 (booster), single (Lot number: En6204), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Spinal stenosis" (unspecified if ongoing). Concomitant medication(s) included: CYMBALTA; LASIX [FUROSEMIDE]; BUSPAR; NEURONTIN. Past drug history included: Benzoyl peroxide, reaction(s): "known allergies: Benzoyl peroxide", notes: known allergies: Benzoyl peroxide. Vaccination history included: pfizer/biontech (Dose Number: 2, Batch/Lot No: Ep7533, Location of injection: Arm Right), administration date: 29Mar2021, for COVID-19 immunization, reaction(s): "COVID-19"; covid19 vaccine (Dose 1, Batch/lot number=Fj1714,, Location of injection=Arm left), administration date: 08Mar2021, for COVID-19 immunization, reaction(s): "COVID-19". The following information was reported: PERICARDIAL EFFUSION (medically significant) with onset 16Jul2022, outcome "not recovered", described as "Heart pericardial effusion 16Jul2022 fluid treated positive for lymphoma."; HODGKIN'S DISEASE (medically significant) with onset 22Jul2022, outcome "not recovered", described as "Diffuse large b cell non Hodgkin's lymphoma 22Jul2022.". The events "diffuse large b cell non hodgkin's lymphoma 22jul2022." and "heart pericardial effusion 16jul2022 fluid treated positive for lymphoma." required emergency room visit. Therapeutic measures were taken as a result of hodgkin's disease, pericardial effusion.; Sender's Comments: Based on the available information  the causal association of suspect drug BNT162B2 and the serious events PERICARDIAL EFFUSION and HODGKIN'S DISEASE cannot be excluded. 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.
Site: Pain at Injection Site-Mild, Additional Details: Gave 0.5ml 3rd dose to immunocompromised patient; dose immediately leaked out of her arm, down to elbow and onto chair.  I called Moderna and was advised to repeat the full 0.5ml dose.  Wanted to document this here, in case needed in the future.
No adverse symptoms present at vaccine site. No adverse symptoms reported after 15 minute recommended wait time.
Weakness; Weakness of arms; Arms felt heavy and dead; Injection site tenderness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), MUSCULAR WEAKNESS (Weakness of arms), LIMB DISCOMFORT (Arms felt heavy and dead) and INJECTION SITE PAIN (Injection site tenderness) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Previously administered products included for Product used for unknown indication: ZOLOFT (Zoloft allergy manifested by depression), CIPRO (Cipro allergy manifested by vomiting) and BACTRIM (Bactrim allergy manifested by vomiting). Past adverse reactions to the above products included Depression with ZOLOFT; and Vomiting with BACTRIM and CIPRO. Concurrent medical conditions included Smoker (About 20 cigarettes per day) since 2009, Alcohol use (A dhot of liquor once or twice a month), Perianal discomfort (Perianal disease), Crohn's aggravated (Crohn's flare up), Topical adhesive allergy (Adhesive allergy manifested by burning and itching on skin), Allergic reaction to antibiotics (Cipro allergy manifested by vomiting), Allergic reaction to antibiotics (Bactrim allergy manifested by vomiting) and Allergic reaction to drug (Zoloft allergy manifested by depression). Concomitant products included BUSPIRONE for Anxiety, PREDNISONE for Crohn's disease, PANTOPRAZOLE for Hyperacidity, BACLOFEN for Spasms.   On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 01-Jun-2021, the patient experienced ASTHENIA (Weakness), MUSCULAR WEAKNESS (Weakness of arms), LIMB DISCOMFORT (Arms felt heavy and dead) and INJECTION SITE PAIN (Injection site tenderness). On 04-Jun-2021, INJECTION SITE PAIN (Injection site tenderness) had resolved. In June 2021, ASTHENIA (Weakness), MUSCULAR WEAKNESS (Weakness of arms) and LIMB DISCOMFORT (Arms felt heavy and dead) had resolved.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.  On 01-Jun-2021, the patient experienced weakness, injection site tenderness and arms felt heavy and dead. On 04-Jun-2021, the injection site tenderness was resolved. In Jun-2021, the weakness and arms felt heavy, and dead resolved.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for Humira 40mg/0.4ml (Adalimumab) for the events of injection site tenderness, arms felt heavy and dead, onset 01-Jun-2021 was not provided.  Treatment information was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-626111 (Patient Link).
Passed out; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided).    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant). On 23-Mar-2021, LOSS OF CONSCIOUSNESS (Passed out) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. No treatment information was provided.; Sender's Comments: This case concerns a 58-year-old male with a serious unexpected event of loss of consciousness. Event onset the same day as first dose mRNA-1273. Event resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Shingles vaccine was administered by the office nurse on the morning of 01/22/09.  Exceptional itching, pain, tenderness, and soreness at the sight of the injection and the area around it (about 4 Sq. in.)became severe late evening of 01/24/09.  That continued through 01/25/09. Problem began to abate late evening of 01/26/09.
Narrative: Patient developed rash at site of administration of COVID-19 vaccine after her second dose. Similar rash developed with the first dose. Patient was given prednisone and symptoms resolved.
Received vaccine yesterday 12/29/20 at 1pm. no symptoms yesterday at all. Woke up this am 12/30/20 at 7am and the injection site (left upper arm deltoid site) is red, swollen, itching, very sore. Right now 12/30/20 at 12:44pm the site looks and feels the same, red, swollen, itching, painful. Just now took 1 tylenol, 1 ibuprofen, 1 claritin. I did not have any other symptoms at all other than what i listed here.
High blood pressure 170s-200 approximately one week after receiving the vaccine; Dizziness; Difficulty speaking; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSIVE CRISIS (high blood pressure 170s-200 approximately one week after receiving the vaccine) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (Medical history was not provided).    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced HYPERTENSIVE CRISIS (high blood pressure 170s-200 approximately one week after receiving the vaccine) (seriousness criteria hospitalization and medically significant), DIZZINESS (dizziness) and APHASIA (difficulty speaking). The patient was hospitalized from sometime in February 2021 to sometime in February 2021 due to HYPERTENSIVE CRISIS. At the time of the report, HYPERTENSIVE CRISIS (high blood pressure 170s-200 approximately one week after receiving the vaccine), DIZZINESS (dizziness) and APHASIA (difficulty speaking) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided  The patient's wife began experiencing dizziness, high blood pressure that ranged from 170s to 200, and difficulty speaking approximately one week after receiving the vaccine.  Treatment for the events, were not provided  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested.
This is a spontaneous report from a contactable healthcare professional via a Pfizer sales representative. A 73-year-old female patient was administered a single dose of PREVNAR 13 in Aug2018, 6 days before this report, for immunization. Medical history and concomitant medications were not reported. The patient experienced a mild hive-like rash the evening of vaccine administration, which has gotten progressively more exaggerated over the course of the past few days. Outcome was not recovered.  Information on the batch number has been requested.
Dizziness and vertigo began approximately March 1, which was a few days after I received the second Pfizer vaccine.  Vertigo has continued to present (4/20/21) when I move from a vertical position to a prone position and when I move from prone to vertical. The vertigo lasts for less than a minute, but is severe enough that if I'm standing I have to hold on to something or drop to my knees to prevent myself from falling.  I thought this would go away but since it has not I will see my doctor.
It was reported that a 48 year old female patient received a Rabies Imovax IM and a Bayrab on 7/02/00. Reportedly that same day the patient developed a headache, neck stiffness and nausea. The patient was treated with Augmentin for bite. Further information requested.
This spontaneous report was received from a registered nurse regarding a patient of unknown age. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 06-MAR-2019, the patient was vaccinated with improperly stored ROTATEQ (lot # R025732, expiry date: 25-MAR-2020) for prophylaxis (Product storage error). Temperature and time frame of temperature excursion was noted as from 29-JAN-2019 (12 Degree Celsius for 1 hour 21 minutes) to 26-FEB-2019 (10 Degree Celsius for 22 minutes). It was reported that there were no previous temperature excursions. Digital data logger was noted as Yes. No adverse events were reported (no adverse event). The outcome of product storage error and no adverse event was unknown. This was fourth of nine reports mentioned in the report. Sender's Comments: US-009507513-1903USA009054:Master case.
Vaccine on Wednesday 4/28/21.  Started to have mild headache, nausea, generalized malaise and chills on Thursday 4/29/21.  Seemed to then improve but then became lightheaded and dizzy.  Came to emergency room 5/2/21 at 1000.  BP stable at 136/69, O2 sat 99% on room air.  No significant findings on blood work (CMP, CBC, Troponin, BNP, TSH all within normal limits).  Chest Xray was normal.  EKG showed atrial fibrillation with rapid ventricular rate in the 150s.  She was given IV diltiazem and her heart rate was controlled.  She was admitted to the hospital for observation and conversion from IV to PO diltiazem.  She declined oral anticoagulation.  She was discharged home on 5/3/21 and instructed to follow up with her PCP and was to see cardiology.
received the first dose of Shingrix 4 years ago hadn't received the 2nd one yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 86-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose of Shingrix 4 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: received the first dose of Shingrix 4 years ago hadn't received the 2nd one yet).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 24-AUG-2023 The pharmacist called to inform that a patient that received the 1st dose of Shingrix 4 years ago had not received the 2nd dose yet, which led to incomplete course of vaccination. The reporter consented to follow up
odd body odor; This case was reported by a consumer via call center representative and described the occurrence of body odor in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th October 2022, the patient received Shingrix. In October 2022, less than a week after receiving Shingrix, the patient experienced body odor. On an unknown date, the outcome of the body odor was not recovered/not resolved.   It was unknown if the reporter considered the body odor to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-OCT-2022 Reporter's Comment: The case was self reported by the patient. The patient received a dose of Shingrix and since then experienced an odd body odor. The reporter gave medical disclaimer and referred to health care professional. Adverse event filed. The reporter spoke per package insert and content and after call survey offered package insert. The reporter did not consent to follow up.
States she had local swelling initially, then noticed redness and rash on 2/21 in the afernoon. Also noticed ras on anterior abdomen and started with dry cough on 2/22/11. Did state she had a headache following the vaccine.