chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Paralyzed from the neck down; Heart failure, had to be paddled, Up and down; This serious case was reported by a consumer via interactive digital media and described the occurrence of paralysis in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced paralysis (Verbatim: Paralyzed from the neck down) (serious criteria hospitalization and GSK medically significant) and cardiac failure (Verbatim: Heart failure, had to be paddled, Up and down) (serious criteria hospitalization and GSK medically significant). The outcome of the paralysis was recovering/resolving and the outcome of the cardiac failure was not reported.   It was unknown if the reporter considered the paralysis and cardiac failure to be related to Shingles vaccine.   It was unknown if the company considered the paralysis and cardiac failure to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-MAR-2023 This case was reported by a patient's family member via interactive digital media. The patient had her shingle shot and 2 weeks later paralyzed from the neck down.  The reporter stated that ambulance rode to hospital, had to be paddled (heart failure) a few days later.  The reporter further stated that up and down, today opened her eyes and wiggled her toes and praying for a turnaround. The follow up would not possible as no contact details were available.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Jan2021 at 13:30 as dose 1, single (Lot number: EL3248), in left arm, on 02Feb2021 at 13:30 as dose 2, single (Lot number: EN5318), in left arm and on 05Oct2021 at 14:30 as dose 3 (booster), single (Lot number: EW0186) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Well controlled hypertension" (unspecified if ongoing), notes: Well controlled hypertension. Concomitant medication(s) included: NORVASC. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Apr2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Apr2022) Positive.   Clinical course: COVID related heart attack on 18Apr2022 after testing positive for COVID on 08Apr2022 with cardiac arrest x2 stent occlusion 2 hours after placement CCU stay with intubation, defribillation and temporary pacemaker. Treatment received for events Cardiac arrest and Heart attack included Catherization, stent, defribillation, intubation.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Vaccination failure, Covid 19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
ASYMPTOMATIC; ADMITTED FOR AMS X 1 DAY (1/6/22) ATTRIBUTED TO HEPATIC ENCEPHALOPATHY
expired Typhim Vi vaccine that was administered to a patient with no adverse event; Initial information received  on 02-Nov-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who received expired Typhoid Vi Polysaccharide Vaccine [Typhim Vi] vaccine, with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in 2023, the patient received a dose of suspect expired Typhoid Vi Polysaccharide Vaccine, solution for injection (lot number: not reported, expiry date: 28-Oct-2023) via unknown route in unknown administration site for immunization), with no adverse event (expired product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the 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.
With 15 minutes of receiving the JandJ covid vaccine  my left arm ached from my shoulder to my hand.  I also had extremely blurry vision that lasted about 30 minutes. About 4 hours later I had pain behind my left eye.  The next morning upon waking, my left arm, shoulder, and back of left leg ached.  Could not use my left hand or arm to lift or hold.  Left wrist and elbow swollen.  Ached behind both eyes comes and goes.
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 17-AUG-2017, the patient was vaccinated with VARIVAX (lot # N002204, expiration date 19-JAN-2019) (route, dosage and frequency were not reported) which was improperly stored. The sterile diluent used to reconstitute the VARIVAX was properly stored. No symptoms reported. The vaccine was stored at -1.6 degree centigrade for 15 hours. The vaccine had previous temperature excursion which was stored at a temperature from -9 degree centigrade to 8 degree centigrade for 30 hours and 15 minutes. Data logger was involved. No further information was provided. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA010756: US-009507513-1708USA010757: US-009507513-1708USA010758: US-009507513-1708USA010759: US-009507513-1708USA010760: US-009507513-1708USA010761: US-009507513-1708USA010762.
This spontaneous report was received from a consumer (the patient's mother) who posted the information on social media via a company representative and refers to a 13 year old female patient. No information about the patient's medical history, concomitant medications and drug reactions or allergies was reported. On an unknown date, the patient was vaccinated with GARDASIL 9 injection (dose, route of administration, anatomical location, lot # and expiry date were not specified) as a vaccination against Human Papilloma Virus (HPV). On an unknown date, the patient experienced hematoma in the muscle of the arm where she received the GARDASIL 9 injection. The patient also experienced headaches, nausea, vomiting and severe fatigue on an unknown dates. The patient sought medical attention by contacting a physician. The outcome of the events was unknown. The reporter did not provide the causality assessment between the events and GARDASIL 9. Upon internal review, the event of hematoma in the muscle was considered to be medically significant. Additional information is not expected as there was no consent for further contact given.
Patient reports developing shivering, shakes, muscle aches, and headache the afternoon and evening of the administration date, and the next day she was very fatigued and slept most of the next day. On the following day she felt normal.
MEDICATION ADMINISTRATION ERROR..  PATIENT GIVEN AN UNDILLUTED DOSE OF PEDIATRIC PFIZER.
I had a sore arm, then it went away, and one week later it came back extremely itchy, red and raised, 4x2 rash. which lasted 4-5 days
Hot itchy and red at injection site within 30 minutes. Hard and painful for 4 days, then faded on 6th day came back, warm to touch, hard to touch and odd shaped, red and itchy. It's manageable  but reporting to aid in tracking side effects.
mild shortness of breath, tested positive in Nursing home , sent to hospital tested positive on 1/22/22.
I received the following doses of the COVID Vaccine 1st dose:  Pfizer EN6204 on 3/13/21 2nd dose:  Pfizer ER5234 on 4/5/21 3rd dose: Pfizer FF8839 on 10/5/21 4th dose: COVID 19 Moderna Updated Booster 12+ on 1/23/23 I did not have any lingering effects from any of the shots until a week after I received the Moderna Updated Booster on 1/23/23 . A few days after that shot the ringing in my ears was intermittent. But 9 days after that shot (2/1/23) I began to have constant ringing in my ears (tinnitus) that has not stopped since.
Scar tissue from 14 years ago inside lower lip swelled up, was bright red and raw; Scar tissue from 14 years ago inside lower lip swelled up, was bright red and raw; itchy at the injection site; rash at injection site; burning at the injection site; Muscle ache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Scar tissue from 14 years ago inside lower lip swelled up, was bright red and raw), LIP ERYTHEMA (Scar tissue from 14 years ago inside lower lip swelled up, was bright red and raw), INJECTION SITE PRURITUS (itchy at the injection site), INJECTION SITE RASH (rash at injection site) and INJECTION SITE PAIN (burning at the injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and ESCITALOPRAM OXALATE (AVESTALO) for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced MYALGIA (Muscle ache) and FATIGUE (fatigue). On 12-Mar-2021, the patient experienced LIP SWELLING (Scar tissue from 14 years ago inside lower lip swelled up, was bright red and raw), INJECTION SITE PRURITUS (itchy at the injection site), INJECTION SITE RASH (rash at injection site) and INJECTION SITE PAIN (burning at the injection site). 12-Mar-2021, the patient experienced LIP ERYTHEMA (Scar tissue from 14 years ago inside lower lip swelled up, was bright red and raw). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. On 12-Mar-2021, MYALGIA (Muscle ache) had resolved. At the time of the report, LIP SWELLING (Scar tissue from 14 years ago inside lower lip swelled up, was bright red and raw) and LIP ERYTHEMA (Scar tissue from 14 years ago inside lower lip swelled up, was bright red and raw) was resolving, INJECTION SITE PRURITUS (itchy at the injection site) and INJECTION SITE PAIN (burning at the injection site) outcome was unknown and INJECTION SITE RASH (rash at injection site) and FATIGUE (fatigue) had resolved.            Concomitant medications were not provided.  Action taken with mRNA-1273 in response to the event was not applicable   This case was linked to MOD-2021-079367 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Provided the Email address.
DTAP was given in left arm above hemangioma. 24 hours, post vax, mom reported swelling and warmth in the arm. Arm measurement was 9" in left arm and right arm was 7 1/2".
CDC reports: 4 mo infant developed fever to 104 & screaming episode following DTP/OPV immunization, duration of illness 1 day.
States he started feeling hot, lowered to the ground. Did hit his head. states this has happened in the past with blood draws. Has allergies to PCN= Hives. Awake and alert x 3 99% O2, RR 18, BP 156/84, HR 88 Feels better while sitting in observation Only medical history hypertension and patient doesn't take any meds
pt recvd vax & became less reponsive & would not eat; vaccinated @ between 2-3PM was taken to hosp 8PM; pt examined ER & told to keep trying to awake; next day still hard to arouse & dec eating;
Nausea; Headache; Chills; Dizziness; Feeling unwell; Tiredness; Pain at injection site; Could not sleep the night of thesecond vaccine.; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old-female non-pregnant patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205), via an unspecified route of administration in the left arm on 06Mar2021 at 01:45 for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medications included DYAZIDE, vitamin C (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN), fish Oil (MANUFACTURER UNKNOWN), biotin (MANUFACTURER UNKNOWN) and flavonoid (MANUFACTURER UNKNOWN); all were taken for unknown indication from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9266), via an unspecified route of administration in the left arm on 13Feb2021 at 01:45 for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was tested for COVID-19. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. On 06Mar2021, the patient could not sleep the night of the second vaccine and experienced nausea, headache, chills, dizziness, feeling unwell, tiredness and pain at injection site at night. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatment was received for the adverse events. The clinical outcome of the events could not sleep the night of the second vaccine, nausea, headache, chills, dizziness, feeling unwell, tiredness and pain at injection site was recovered (all for a couple of days) at the time of reporting.   No follow-up attempts are needed. No further information is expected.
received Menveo reconstituted with Pfizer Covid diluent; received Menveo reconstituted with Pfizer Covid diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA569A, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Menveo lyophilized powder portion after being reconstituted with pfizer covid diluent when the patient was supposed to get the covid pfizer, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. No reactions reported. The reporter consented to follow up. This case was linked with 12 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR243469:Same reporter US-GLAXOSMITHKLINE-US2021AMR243472:Same reporter US-GLAXOSMITHKLINE-US2021AMR243470:Same reporter US-GLAXOSMITHKLINE-US2021AMR243474:Same reporter US-GLAXOSMITHKLINE-US2021AMR243475:Same reporter US-GLAXOSMITHKLINE-US2021AMR243476:Same reporter US-GLAXOSMITHKLINE-US2021AMR243477:Same reporter US-GLAXOSMITHKLINE-US2021AMR243478:Same reporter US-GLAXOSMITHKLINE-US2021AMR243479:Same reporter US-GLAXOSMITHKLINE-US2021AMR243480:Same reporter US-GLAXOSMITHKLINE-US2021240689:Same reporter
Pt received vaccines at morning appt on 11/22/21. She reports intermittent right hand tremor began that afternoon. Experienced intermittent bilateral hand tremor the next day. Seen in the office on 11/24 reports symptoms are improving. In
I usually suffer anxiety and panic attack;  It induced the panic attack; I felt a bit sluggish; get tired; I felt a bit sluggish; get tired; my arm was sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Jun2021 15:00 (Lot number: EW0182) at the age of 29 years as dose 2, single dose for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1st, Batch/lot number  : EW0173    , Anatomical Site : Left arm), administration date: 06May2021, for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 08Jun2021, outcome "unknown", described as "my arm was sore"; SLUGGISHNESS (non-serious), FATIGUE (non-serious) all with onset 09Jun2021, outcome "unknown" and all described as "I felt a bit sluggish; get tired"; PANIC REACTION (non-serious), outcome "unknown", described as "I usually suffer anxiety and panic attack;  It induced the panic attack". Therapeutic measures were not taken as a result of pain in extremity, sluggishness, fatigue, panic reaction.  Additional information: Consumer stated, Okay so yesterday he got it on 3 obviously his arm was sore that's given he was okay, this morning its in for today at work he felt a bit sluggish and that's all you know the doc said you get tired you know really sluggish but he usually suffer anxiety and panic attack. It induced the panic attack which you know he haven't heard of anybody having panic attack. So he don't know if its because he usually have panic attack but so it kind slowly brought the panic attack all at work and then sent him up. Patient not taken any other vaccines 4 weeks Prior Vaccination.  No follow-up attempts are possible. No further information is expected.
"frog in her throat"/sore throat; left ear became "really hot", and her neck felt warm; being very thirsty; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT, THIRST, and OROPHARYNGEAL PAIN in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     The patient's past medical history included Anxiety and Depression. Concurrent medical conditions included Hypertension. Concomitant products included METOPROLOL, HCTZ, and SERTRALINE for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced FEELING HOT, and THIRST. On 29-Mar-2021, the patient experienced OROPHARYNGEAL PAIN. The patient was treated with TYLENOL at an unspecified dose and frequency. At the time of the report, FEELING HOT, THIRST, and OROPHARYNGEAL PAIN outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment medications to the events includes drinking fluids. The consumer stated that the second dose in the series from Moderna's vaccine is scheduled for today (30Mar2021).
Information has been received from a registered nurse concerning a patient who on an unspecified date was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, the patient developed an undiagnosed rash. At the time of the report the patient's status was unknown. Additional information has been requested. This is one of several reports from the same source.
This initial spontaneous report was received from a 60 year old female patient referring to herself. Concurrent conditions included bipolar disorder. She was allergic to unspecified medications. Concomitant medications were PRISTIQ, lithium, LAMICTAL, and topiramate. On 31-AUG-2016, the patient received ZOSTAVAX, 0.65 ml, subcutaneously for the prevention of shingles (lot # not provided). She also received the sterile diluent (lot # not provided). The patient reported that she has had gradual hearing loss "ever since". She then report the onset to be in approximately February 2017 (reported as about six months after receiving the vaccine). The patient sought medical attention (she saw an audiologist). Her last hearing test conducted on 05-JUN-2018 showed mild to moderate hearing loss on her right side and moderate to severe hearing loss on her left side. No treatment was given. The event was not recovered at the time of the report. Causality assessment was not provided. The patient was requesting compensation. Upon internal review, deafness bilateral was considered medically significant. There was no consent to contact the reporter.
Patient presents to the ED with shortness of breath. Patient was admitted for covid and further evaluation and treated with remdesivir.
This case was reported by a nurse via sales rep and described the occurrence of fever in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: The case was reported by nurse for herself. The age at vaccination was not reported. The age group was not reported, but was captured as adult as per vaccine indication. The patient experienced fever of 101 degrees Fahrenheit which lasted 2 days. No additional information were provided. After 2nd dose of SHINGRIX the patient experienced fever for tolerance refer case US2018GSK185871.  Lab Comments: On an unspecified date, the patient's body temperature was measured.
Dizziness, hot, clammy hands, auditory overload, SOB, numbness, tingling
Hives all over face, also on chest and left arm; very itchy and red. Took 1 antihistamine and hives started fading and were mostly gone 1-2 hours later.
Pt devel lupus following vax of Hep b vax & no further details were provided;
only the liquid portion / was administrated; only the liquid portion / was administrated; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Previously administered products included Menveo (1st dose received on unknown date).   On an unknown date, the patient received the 2nd dose of Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provide are as follows: The age at vaccination was not reported. The patient received only the liquid portion of the Menveo vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter had no information regarding the patient, nor the date of the administration.  The reporter reported that they realized this happened due to the fact that they found a remaining powder portion of the vaccine without the accompanying diluent.  The reporter had no information for the lot number and expiration date of the portion administrated at the moment of the call. The reporter agreed to be contacted for follow-up through their email address. No further events were reported.  The reporter consented to follow-up. The case has been linked with case US2021AMR158869 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR158869:Same reporter
About 1 1/2days after injection of FluMist, go the flu, runny nose, congestion, minor cough, aches, and tight chest-every time I inhale to max it hurts in my chest.  Some movement hurts in my chest/heart area.