chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax & 25OCT early AM lt arm throbbing-took advil;malaise & body aches which improved by SUnday;26OCT97 fine rash upper body noted in evening;lt arm had become tender, red, swollen including axilla & hot;
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.A 68 year-old male patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: EL9262) as dose 1 single and administered in arm left (Lot number: EN9581) as dose 2 ,single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 18Feb2021, outcome "recovered" (Feb2021), described as "Sore injection site"; FATIGUE (non-serious) with onset 19Feb2021, outcome "recovered" (Feb2021), described as "Fatigue"; PAIN (non-serious) with onset 19Feb2021, outcome "recovered" (Feb2021), described as "Body aches". Therapeutic measures were not taken as a result of vaccination site pain, fatigue, pain.No follow-up attempts are possible. No further information is expected.
Presented with SOB/weakness; Date of onset of symptoms 12/24.  Tested positive on 12/27.   Tx: completed 5 days remdesivir, IV Solu-Medrol; Zithromax, Lovenox, merrem, singulair, zinc; AKI on CKD 3:  Suspect either due to over-diuresis or COVID-19 infection.  Has improved back to baseline. Minimal supplemental O2 needed; did require bipap briefly initially; down to baseline of 4 LPM o2 at time of d/c
Vaccine received 11/8/04, on 11/25/04 papules develop, lymph nodes enlarge on neck, axilla and groin. Arthritic joints all last 7-10 days, ER visit dx chicken pox. Prescribe acyclovir. Not taken.
Patient inadvertently inoculated self with smallpox.  Pt cross-contaminated self. Unknown how it happened. Pt has 2 small vesicles on left lower quadrant of abdomen. Pt is experiencing itching at site. No treatment. Pt advised to watch site and no contact to skin.
Very sleepy, as if i had anesthesia.  My arm hurts, I can't touch it, and it hurts to move it.
dose was prepared from vial that was stored in freezer at -25C to -15 C for a total of 19 days which exceeds the allowable time at this temperature ( per manufacturer website, 17 days)
Case number PHEH2014US022424 is an initial spontaneous report received from a nurse on 07 Nov 2014. This report refers to a 12 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with an intramuscular dose of MENVEO (batch number: 14042) on an unknown date. It was reported that the vaccine administered was exposed to temperature in between 22 F for two hours on 06 Nov 2014. No adverse events were reported following the medication error.
Information has been received from a consumer reporting that he knows of several cases of seizures after receiving GARDASIL vaccine. Upon internal review, seizures was considered to be an other important medical event. This is a hearsay report in the absence of an identifiable patient. Attempts to verify the existence of a patient have been unsuccessful. This is one of two reports from the same source. Additional information is not expected.
Second dose over 59 days after first one; A spontaneous report, was received from a pharmacist, concerning a female patient of unknown age, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and had second dose over 59 days after first one (inappropriate schedule of product administration).   The patient's medical history was not provided. Concomitant medications were not reported.     On 31 Dec 2020, prior to the onset of the event, the patient received the first of two planned doses of mRNA-1273 (lot/batch: unknown), intramuscularly for the prophylaxis of COVID-19 infection.   The patient received the first Moderna vaccine on 31 Dec 2020 and didn't get rescheduled for her second dose. Its been 59 or 60 days since the first dose was given to the patient. Treatment information was not provided.    Action taken with second dose of mRNA-1273 in response to the event was not provided.  The outcome of the event, second dose over 59 days after first one was considered as recovered.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested
fever to 104 treated w/APAP; pink, flat small rash began 1 wk p/vax;
have fluctuations in his platelets about 2 months after receiving his second dose of the Pfizer COVID-19 vaccine; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer. A 67-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), on an unspecified date as single dose for covid-19 immunization. On an unspecified date it was reported that patient started fluctuations in his platelets about 2 months after receiving his second dose of the Pfizer COVID-19 vaccine. His platelets have gone wild. He has never had this problem before they were in the 200s, then they dropped to 60 and then on repeat blood test it went to 700. Every time he goes the numbers are from 70-600 with wild variations. He has been seeing an Oncologist/ haematologist and they are running other tests as the doctors state they are not familiar with this. In response to platelets fluctuations informed that prescribing information for Pfizer COVID-19 Vaccine did not find information regarding platelet fluctuations as the prescribing Information does not include all adverse reactions that have been reported or that may occur. Hence patient was asked to consult with his doctor/healthcare provider about what he experienced/are experiencing as the doctor/healthcare provider will be most familiar with his medical condition, clinical history, how the treatment has been conducted and any relevant information to his specific case and is in the best position to advise about the appropriate action to take. It was reported that no patient identifiers were provided but the reporter has first hand knowledge of the patient and was reporting on a specific patient. On an unspecified date, the patient underwent lab tests and procedures which included platelets resulted as he had never had this problem before they were in the 200s, now they dropped to 60 and then on repeat blood test it went to 700. Every time her goes the numbers are from 70-600, with wild variations. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Swelling and irritation in left arm, gotten worse in over 24 hours. Sever headaches, irritability, fatigue,  nausea.
Pt developed fever of 101.2 F PO and mild headache approximately 12 hours post-administration. Complaint reported by pt's mother via telephone. Fever decreased to 99.8 F PO at 8:30 am the following day. No treatment recommended aside from watch and wait.
It's been more than a month since I got my Janssen shot. My left arm's injection area is sometimes red and itchy.  At the same location, I have 6 other TB shots. I am not sure if they have reactions between Janssen and TB shots.  Also, the red itchy area has expanded toward my neck and upper back area.
Got the flu shot was sick with the flu for 3 weeks; Initial information received on 16-Nov-2020 regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (consumer).  This case involved an unknown age patient for whom it was reported got the flu shot was sick with the flu for 3 weeks (illness), after receiving vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, unknown latency, after the patient got the flu shot was sick with the flu for 3 weeks (illness).  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome of the event of illness was unknown.  There will be no information available on the batch number for this case.
Patient received vaccine at 2:20 PM and showed no symptoms initially. His wife was having syncopal symptoms and he helped care for her while paramedics were on their way. After they arrived he experienced lightheadedness and blurry vision. He was evaluated by they team and they determined the cause to be vasovagal syncope. He recovered and declined transport. He left on his own accord after 40 minutes feeling back to normal.
Information has been received from a consumer concerning an 8 year old patient who may have been vaccinated with a dose of varicella virus vaccine live. Subsequently the patient experienced a mild case of chickenpox and died while recovering from the chickenpox. The exact cause of the patients death was not determined, but local officials say they doubt chickenpox is to blame. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 26-NOV-2014 the patient was inadvertently vaccinated with an expired dose of VAQTA (0.5 ml, intramuscular, lot # 0271AE, expiration date 20-NOV-2014). No adverse effects reported. Additional information has been requested.
Pt c/o nausea/HA/fever/myalgia x 4 days.  Pt states his sx have resolved today and needed a rtw note.
Symptoms started Friday, 11-23-2012, Stiffness to right side of neck- by Saturday pain in left neck radiated to elbow; shoulders very painful. Took Ibuprofen and alternated with acetaminophen, took left over hydrocodone-dulled, never took away. Had appt -ENT gave oxycodone-made appt for neurologist. Scheduled for MRI's 13th/14th if December. Called it Brachial Neuritis or Parsonage Turner.
Narrative:  A 45yo female presented to the ER to establish care reported to nurse Moderna Covid-19 vaccine induced throat swelling which occurred immediately after she received the vaccine . Nursing note indicated the patient received the first Moderna covid - 19 vaccine on April 15, 2021 and reported she was advised not to take the second dose or the boosters. No other detailed information regarding the vaccine were reported. The report did not include whether the patient received any treatments for the swelling.
in addition to pain/swelling at injection site, I have noted a large rash, approximately 3 inches in diameter
Pt recv vax on 2/10/99; 36 hr post vax pt exp nausea, vomiting & headache x 12 hr
vomiting began 3 days after vaccination fever up to 102 began 4 days after vaccination sore throat, congestion, body aches persist 5 days after
Pt received the Moderna vax on 1/20/2021and 2/17/2021. Pt states that she felt "perfectly fine"  the first two days and began to notice sever hair loss day 3- 8 after the vaccine. Pt States that she did not experience any other symptoms besides hair loss. her hair loss lasted 5-7 days following her vaccine.
Permanent hearing loss on left ear; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEAFNESS UNILATERAL (Permanent hearing loss on left ear) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced DEAFNESS UNILATERAL (Permanent hearing loss on left ear) (seriousness criterion disability). At the time of the report, DEAFNESS UNILATERAL (Permanent hearing loss on left ear) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging head: no infections or tumors (normal) No infections or tumors.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  The patient has been evaluated by ENT several times and was given steroid treatment in response to the event.; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the reported events, a causal relationship cannot be excluded.
On the day of both shots, arms were sore.; And there was a considerable increase of energy and alertness felt.; This is a spontaneous report from a contactable Nurse (Patient).  A 29-year-old non-pregnant female patient received BNT162B2 (BNT162B2 Formulation: Solution For injection Batch/Lot number: Unknown Expiration Date: Unknown) via intramuscular route of administration, administered in Right Arm on 27Jan2021 10:30 (at the age of 29-year-old) as DOSE 1, SINGLE and received BNT162B2 (BNT162B2 Formulation: Solution For injection Batch/Lot number: Unknown Expiration Date: Unknown) via an unspecified route of administration, administered in Left Arm on 22Feb2021 as DOSE 2, SINGLE for COVID-19 immunization. No COVID prior vaccination and Patient was not tested for COVID-19 post vaccination. Patients Medical history and concomitant medications were not reported. No known allergies. On the day of both shots, arms were sore. And there was a considerable increase of energy and alertness felt on 27Jan2021 10:30. No treatment received. Outcome of both the events was recovered.  Information about lot/batch number has been requested.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
B/L rash on arms 4 days after vaccines, spreading from injection sites down both arms.
ACUTE DVT OF RIGHT PERONEAL VEIN ACUTE PULMONARY EMBOLISM
Information was received on 26-SEP-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age, who on 18-OCT-2016, received a dose of the ZOSTAVAX vaccine for it's intended purpose: the prevention of shingles. A few days later, the patient began to develop a rash on her shoulder, both ears, and scalp, characterized by blistering, pain and redness, as well as joint pain and fatigue. The patient was diagnosed with herpes zoster. The patient still suffers from this condition and medicine does not help. As a direct and proximate result of the defective ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations from, and seriousness of her condition. As a result, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of the use of ZOSTAVAX. Herpes zoster was considered disabling. Additional information has been requested.
Error of expired Janssen dose given. Janssen vial opened 11/4 at 1915. Doses are normally discarded when clinic closes for the night but this time it was not. Vial was left in refrigerator. Patient received Jannsen 0.5 mL IM 11/5 at 1128 (~10 hours expired). Dose was stored in refrigerator. Spoke with Janssen who stated they did not have any additional information on the stability and to consider the vaccine expired. They said to defer to provider to make a clinical decision. Janssen case file (redacted). Same day care manager called patient to relay that does was expired and physician recommended a repeat dose (ID provider Dr.). Patient lives far away and did not want to come back for a second dose. No active side effects as of phone call to patient on 11/10 per manager
Chronic arm pain at injection site, and entire arm weakness and soreness extending down to wrist and up to shoulder. This has lasted since the time of receiving vaccine and has not resolved after 7 weeks.
Death Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 82 and had a PMH significant for parkinsonism w/ dementia, difficulty walking and performing daily tasks, CAD, afib, and osteomyelitis. Patient was authorized for home health aide on 3/18/21 after wife overwhelmed with his care. Listed cause of death on death certificate says "unknown-history of dementia and heart conditions"
Injection site turned red, hot, and slightly itchy on 1/11/2021, one week and two days after receiving the first dose of the vaccine.
10/9 Client developed itching to injection site. Fluzone Intradermal was adminstered to left arm. 10/10 Itching increase then redness noted at injection site. 10/11 Client C/O nausea and pain to left arm radiating to left breast and axillary area and unable to raise left arm. 10/12 C/O headaches, eyes pain, bodyache, diarrhea, nausea and cough. 10/15 Seen by MD. Rx given for pain and nausea. Client indicated her MD stated her symptoms are possibly as a result of the influenza vaccination.
Pt. came in today with red bump/spots all over body - scattered. Itchy to Pt. Dr. saw pt. today. Gave ATARAX to treat for itching.
Vomiting periodically throuout the night.  At least 6 episodes.  Violent/severe in nature.  Could not retain any fluids.  Throwing up yellow bile from the second episode on.  Severe chills.  Severe perspiring throughout the night.  Fatigue.
Vaccinated with dose #2 on 1/17. On 1/20, developed a headache, dizziness, and sore throat. She states it felt the same covid symptoms she had in October (test for covid + on 10/09/2020). Swabbed at medical center on 1/21/2021. Swab returned a not detected result. Symptoms have resolved.
ADMINISTRATION OF EXPIRED VACCINE TO 3 FEMALES; This spontaneous report received from a health care professional concerned multiple patients.  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: 207A21A, expiry: 21/SEP/2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-SEP-2021, the patient experienced administration of expired vaccine to 3 females. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine to 3 females was not reported. This report was non-serious. This case, from the same reporter is linked to 20210955823.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 01-JUL-2011, the patient was inoculated with ZOSTAVAX (Dose, route of administration, site of administration, Lot number and expiration date were not provided) at a medical group office (by an unspecified health care professional) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 26-JUL-2012, the patient was treated by a physician at an office facility for a blistering vesicular outbreak, which was diagnosed as shingles. The patient has been prescribed acyclovir and oxycodone to help manage her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
Mild fever; bodyaches; chills; weakness; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 34-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 at 13:30 as dose 1, single (Batch/Lot number: unknown) intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "history of TB" (unspecified if ongoing). Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation, start date: 20Sep2023, stop date: 20Sep2023. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 11Oct2023 at 01:00, outcome "recovering", described as "Mild fever"; PAIN (non-serious) with onset 11Oct2023 at 01:00, outcome "recovering", described as "bodyaches"; CHILLS (non-serious) with onset 11Oct2023 at 01:00, outcome "recovering"; ASTHENIA (non-serious) with onset 11Oct2023 at 01:00, outcome "recovering", described as "weakness". Therapeutic measures were not taken as a result of pyrexia, pain, chills, asthenia.  Additional information: It was reported that the patient received other vaccination (flu vaccine) and medication (multivitamin once a day) in two weeks. The patient was not tested COVID prior or post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The patient said next day she felt as if a truck ran her over. Hurt all over and was mentally "out-of-it." This feeling lasted for days after injection. She consulted with her primary care md. She stayed home and rested but I do not know if pcp prescribed any medications. Unknown patient not answering phone.
Ecchymosis began around 8pm left upper arm. Morning of 7/24/10 increased ecchymosis measuring 3inches X 3 1/2inches. Taken to urgent care facility around 1pm was told to ice the area and use Tylenol or Benadryl prn. by 7pm 7/24 fluid filled blisters started forming within the bruised area (blister area is about 1 inch the total of bruised area) c/o pain with palpation.
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Mild, Additional Details: Patient returned 4 days after recieving injections and was encouraged to see physician.