chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; The (BUD) refrigeration date was on 01-Jul-2022 and vaccine was adminstered on 11-Jul-2022; Erroneously vaccinated  clients with expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Erroneously vaccinated  clients with expired vaccine), PRODUCT STORAGE ERROR (The (BUD) refrigeration date was on 01-Jul-2022 and vaccine was adminstered on 11-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 54-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 11-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Erroneously vaccinated  clients with expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The (BUD) refrigeration date was on 01-Jul-2022 and vaccine was adminstered on 11-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Erroneously vaccinated  clients with expired vaccine), PRODUCT STORAGE ERROR (The (BUD) refrigeration date was on 01-Jul-2022 and vaccine was adminstered on 11-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Erroneously vaccinated  clients with expired vaccine) and PRODUCT STORAGE ERROR (The (BUD) refrigeration date was on 01-Jul-2022 and vaccine was adminstered on 11-Jul-2022).    No concomitant medications were reported.  Vial size was reported as 5.5 mL.  Vial did not undergo any temperature excursion. No treatment information was provided.
Hospitalized (10.13.21 - present / still hospitalized);  COVID-19 positive (10.13.21);  Fully vaccinated  Chief Complaint: Falls Reason for Admission: Ataxia, COVID-19 Patient is a 68 y.o. male with a past medical history of HTN, HLD, cryptogenic CVA postoperatively from back surgery in 2019 (vision changes of R eye, parethesias, dysphagia, dysarthria), carotid artery stenosis, remote 48 py smoking hx, CAD s/p CABG, GERD, depression, presenting with several days of cough and congestion as well as worsening ataxia resulting in multiple falls at home. The patient was in his usual state of health her until approximately Tuesday 10/5.  He developed congestion, fatigue, myalgias, fevers and chills.  He had recently been exposed to his ex-wife who is found to be COVID positive.  He has been vaccinated with the Johnson & Johnson vaccine.  His symptoms progressed and he developed cough and mild shortness of breath.  However 3-4 days prior to admission he developed worsening bilateral lower extremity weakness and inability to maintain his balance resulting in 4-6 falls in the last 24 hours.  During 1 of these falls he did hit his head.  He denies any dizziness or lightheadedness but feels that he just can not maintain his balance when he is walking.  No other focal numbness tingling weakness of his arms or legs.  He does have a history of stroke postoperatively after his back surgery in 2019. He has a history of coronary artery disease and has had a CABG in the past.  He otherwise denies headache or nuchal rigidity/neck pain.  He does have mild chest pain with cough but it is not persistent and unless he is coughing.  No shortness of breath at rest.  His ex-wife is present at bedside and corroborates this history. Due to his worsening falls and gait he presented to the emergency department when he was found to be afebrile saturating 90-93% on room air.   Progress note from 10.20.21:   Acute hypoxemic respiratory failure due to COVID-19  Assessment & Plan Secondary to COVID-19 pneumonia.  CT angiogram ruled out PE 10/14/2021, but did reveal infiltrates consistent with COVID-19 pneumonia.  Patient had been improving, and symptoms began 10/05/2021.  Over the weekend, had worsening respiratory status, now on 15 L Oxymizer.  D-dimer is now elevated, previously had been normal.  Proceeding with CT angiogram thorax repeat, to ensure no pulmonary embolism is developed to account for his decompensation.  Continue dexamethasone and remdesivir.  Completing empiric Rocephin and doxycycline. Concern for development of organizing pneumonia in the setting of COVID-19.  Patient has completed remdesivir, as well as a 5 day course of empiric Rocephin and doxycycline.
Narrative:  78yo male patient with medical history of CA - Cancer of pancreas (SCT 363418001) CAD - Coronary artery disease (SCT 53741008) Ulcerative colitis (SCT 64766004) Hyperlipidemia (SCT 55822004) Dry eye syndrome (SCT 46152009) Leukopenia (SCT 419188005) Obstructive sleep apnea syndrome (SCT 78Hearing loss (SCT 15188001) Pt did not receive oncology care from agency. Pt died on 10/18/2021. No infor regarding circumstances of death given. Likely this death is not related to covid vaccines given patient's age, comorbidities, and long length of time between date of vaccines and date of death.
Mild agitation; soreness at injection site; Head/Brain Fog for 24 hours after injection; feeling "out of it" and inability to concentrate fully; This is a spontaneous report from a contactable Consumer. A 59-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 11:00 at left arm at single dose for covid-19 immunization. The patient's medical history had allergic to other vaccine ingredients, particularly influenza vaccine ingredient. The patient's concomitant medication included Dietary Supplements. The patient received the first dose of BNT162B2 on 28Dec2020 14:00 at left arm for covid-19 immunization. The patient was not pregnant. The patient experienced mild agitation, soreness at injection site, head/brain fog for 24 hours after injection and feeling "out of it" and inability to concentrate fully on 19Jan2021 16:00. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events mild agitation, soreness at injection site and 'feeling "out of it" and inability to concentrate fully' was recovered on an unknown date in Jan2021, the outcome of the event head/brain fog was recovered on 20Jan2021 16:00. Information on the lot/batch number has been requested.
Only got Hib & PC vaccines.  Fever of 101 @ 7am.
break through case greater than 14 days post fully vaccinated Narrative:  break through scase greater than 14 days post fully vaccinated
Reaction started on 1/14 at around 4pm. Red face, itchy skin, burning skin, tingling around and on lips. Gradually, raised hives spread over entire face and neck, and into hairline. My eyelids began to swell. I treated with 2 Benedryl, every 4 hours. 1/15: I woke up with face and eyes swollen, red blotches all over face, continued to treat with Benedryl. 1/16: swelling began to go down, redness began to subside, continued Benedryl treatment. 1/17: Swelling and redness  continued to go down, continued Benedryl treatment. 1/18: redness and swelling mostly gone, except for minor swelling of left eye. NO Wheezing, swelling of tongue, or chest tightness.
No additional AE; HCP calling to report VARIVAX was administered after it experienced a supported temperature excursion. HCP reports she only knows of one of the patient's names, but there were others who received it as well, additional AE filed under #02486705. No a; This spontaneous report was received from Medical Assistant and referred to a patient of unknown gender and unknown age. Concomitant medications included sterile diluent. The patient's concurrent conditions, historical drugs and historical conditions were not reported.  On 26-SEP-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milligram, lot #X006982, expiration date: 07-MAR-2025, administered for prophylaxis (strength, and route of administration were not provided). It was reported temperature excursion occurred (Temperature: -12 C, Time frame: 55 minutes) (product storage error). There was no previous temperature excursion. No additional adverse event (AE).
low fever; stabbing pain in joints; chills; aches; This is a spontaneous report from a contactable consumer via Pfizer sales representative. A 66-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on 15Oct2020 at single dose for immunisation. The patient's medical history and concomitant medications were not reported. It was reported that later in the day 15Oct2020, the patient experienced low fever, stabbing pain in joints, chills, and aches. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained .
Nausea, vomiting, low grade fever x 2-3 days reported by mother (no office visit). Gave pain reliever, sx resolved.
Received his vaccine at 10:46am. He fainted at 11:05am. The pharmacist ran out to assist him immediately and he was already conscious and sitting up on the floor. He was coherent and able to answer questions.
idiopathic intracranial hypertension with blurry and double vision secondary to cranial nerve 6 palsy
p/vax pt exp chickenpox w/approx 10 lesions on face & back;pt sought unspecified medical attention;
dark blood clot coming out of his penis; Gross Hematuria; dark urine; Redness arm; Sore Arm; Swelling arm; A spontaneous report was received from a healthcare professional who was also a 72-year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events redness arm/ vaccination site erythema, sore arm/ vaccination site pain, swelling arm/ vaccination site swelling, gross hematuria/ hematuria, dark blood clot coming out of his penis/ hemorrhage urinary tract, and dark urine/ chromaturia.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 10 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot batch: 013L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 11 Jan 2021, the patient experienced the events redness, sore arm and  swelling. On 20 Jan 2021, the patient experienced the events gross hematuria, with dark blood clot coming out of his penis. The patient had urine analysis (no results provided), and was still urinating dark urine. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcomes of the events, vaccination site erythema, vaccination site pain, and vaccination site swelling, were considered recovered on an unspecified date. The outcomes of the events, hematuria, hemorrhage urinary tract, and chromaturia, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
This spontaneous report as received from a pharmacist refers to a 26 year old female patient. On 15-MAY-2013 the patient was vaccinated with the first dose of GARDASIL (lot # 1860AA; exp. date 30-SEP-2014; dose and route was unknown). There was no concomitant medication, no medical history and no known drug allergies. Since she received her first dose of GARDASIL, she had a migraine on 15-MAY-2013. She reported that she was in a lot of pain - an 8-9 on a pain scale. The patient treated with TYLENOL, ibuprofen and aspirin. No lab diagnostics was performed. The outcome of migraine was reported as not recovered/not resolved. The event was considered to be an significant disability by the reporter. Patient reported that her physician cannot see her in the office until 12-JUN-2013, so patient might go to the emergency room to seek medical attention. Additional information has been requested.
Reaction noticed 10/27/99 at 10am. Rt arm swollen from elbow to mid-arm. Measured 11 3/4 " around. Lt arm measuring 10 1/2 " around. On 10/29/99, rt arm back to normal size.
25 minutes after the vaccine was given, I felt a rush of cold go down my left arm and had a cold sensation and then tingling/numbness to my left wrist and left hand for about 36 hours until it gradually subsided.
Received vaccine on Friday. On Saturday inj site was red, hot to touch and painful. Sunday rash developed from site of injection and over chest area. Rash was raised with blister like pustules.
High fever  103.5 ,  chills for 6-8 hours,  unable to hold objects without dropping them,  very dizzy, stiff,  unsteady walking,   Nausea, and extreme headache for 4 days and off and on continuing today 9/7/21,  Mouth sores  started day 4 with extreme nausea. Blister on tongue., swollen joints in hand/ pain.   Headache.
Tested positive after two doses of Moderna Vaccine/tested positive for COVID; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Dec-2021 and was forwarded to Moderna on 29-Dec-2021.    This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive after two doses of Moderna Vaccine/tested positive for COVID) in a male patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced COVID-19 (Tested positive after two doses of Moderna Vaccine/tested positive for COVID). At the time of the report, COVID-19 (Tested positive after two doses of Moderna Vaccine/tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, SARS-CoV-2 antibody test: positive (Positive) Positive.         No concomitant medications reported by reporter No treatment medications provided by the reporter. COMPANY COMMENT: This is a spontaneous case concerning an unknown-year-old male patient with no clinical history who experienced the unexpected events of COVID-19  The events occurred unknown days after 2nd dose of mRNA-1273. The rechallenge was not applicable since only information about 2nd dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event terms, seriousness and onset dates were captured as provided by the Regulatory Authority    Reporter did not allow further contact; Sender's Comments: COMPANY COMMENT: This is a spontaneous case concerning an unknown-year-old male patient with no clinical history who experienced the unexpected events of COVID-19  The events occurred unknown days after 2nd dose of mRNA-1273. The rechallenge was not applicable since only information about 2nd dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event terms, seriousness and onset dates were captured as provided by the Regulatory Authority
reported a kinrix maladministration, as an 18 months old male patient/Kinrix out of indication; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 18-month-old male patient who received DTPa-IPV (Kinrix) (batch number 24T2N, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, 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: 16-MAY-2022 Reporter's comment: A nurse reported a Kinrix maladministration, as an 18 months old patient received a dose by mistake. The reporter consented to follow up. Additional supportive information: The patient of 18 months old received a dose of Kinrix by mistake, which led to inappropriate age at vaccine administration.
Pt had two syncopal episodes in parking lot with tingling of lips and arms seen by parents. Then progressive severe HA, vomiting. Admitted and given IV Benadryl. Sent home next day. Per review of the hospital discharge summary the discharge diagnosis was "reaction to hepatitis B immunization".
swelling at injection site; redness at injection site; hot to the touch/It is also hot to the touch; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site swelling, injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site warmth were unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as per the vaccine indication. The patient still have redness and swelling at the injection site two days after receiving 1st dose. It was also hot to touch. The patient asked what could do to relieve the events.
Headaches; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches) and PAIN IN EXTREMITY (Sore arm) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 014M20A) for COVID-19 vaccination.     The patient's past medical history included Gastrointestinal disorder since an unknown date. Concomitant products included LINACLOTIDE (LINZESS) and SUCRALFATE (CARAFATE) for Gastrointestinal disorder, MULTIVITAMINS;MINERALS for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headaches) and PAIN IN EXTREMITY (Sore arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL (TYLENOL EXTRA S. P) for Adverse event, at an unspecified dose and frequency. At the time of the report, HEADACHE (Headaches) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.    This case was linked to MOD-2021-227487 (Patient Link).
Headache, Arthralgia, NauseaVomiting, fatigue Narrative:
swelling of the  left supraclavivular lymphnode; This is a spontaneous report from a non-contactable other healthcare professional. A 41-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular first dose on 21Feb2021 10: 30 am at single dose (Lot Number not reported), and second dose on 14Mar2021 11:30 am (Lot Number: en6204) as single dose, both at site of left arm at the age of 41-year-old for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19. The patient experienced swelling of the left supraclavivular lymphnode on an unspecified date with outcome of unknown.    No follow-up attempts are possible, information about batch number cannot be obtained.
This spontaneous report was received from an office administrator and refers to an unspecified amount of patients (age and gender unknown). The reporter stated that an unspecified number of improperly stored vaccines were administered to an unspecified number of patients. The vaccines were GARDASIL 9 (lot # L040054, expiration 26-DEC-2017), RECOMBIVAX HB (lot # M010671, expiration 02-JUN-2018), ROTATEQ (lot # M017514, expiration 07-NOV-2017 and VAQTA (lot # M027879, expiration 24-JAN-2018). No adverse effects were reported. Additional information has been requested.
few hrs p/vax began to get chills throughout body;body began to feel very tired;during the noc every inch of body was wracked w/pain-cont for the next 36hrs gradually dissapated
Pt rec'd vaccine on 10/12/15. On 10/29/15 he complained of an increase in his preexisting condition of tinnitus and new onset pressure in left ear. Exam reveals both eardrums are not WNL - sent him to his PCP. Doubtful caused by vaccination.
About 25 minutes after vaccination patient reported itchy nose and throat.  Tightening of airway also reported with difficulty swallowing.  50mg diphenhydramine administered and symptom resolution reported by patient 10 minutes after medications.
Initially, bruise at right arm vaccine site, then enlarging red, swollen, painful area. Associated fever 99.4, chills. Currently under treatment.
abscess; administered pneumococcal 13 at patient buttocks; This is a spontaneous report from a contactable nurse received via a Pfizer sales representative. A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at a single dose for an immunisation. The patient medical history and concomitant medications were not reported. It was reported that the Doctor administered pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) at patients buttocks. Patient developed an abscess and ended up to the hospital. Patient was doing okay. The outcome of the event was recovering.   No follow-up attempts are possible, information about batch number cannot be obtained.; Sender's Comments: Based on the information currently available, it cannot be fully excluded that the vaccination with PREVNAR 13 may have played a contributory role in triggering the onset of abscess in the patient.  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.