chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received dose of Janssen COVID 19 vaccine after denying (written documentation on form 4260 and verbal confirmation of written responses during nurse interview). Upon entering documentation in , documentation of previous vaccination discovered for Moderna COVID 19 1st dose (lot 939676) on 07/14/2021   @ the  Clinic., Regional Medical Director fornotified of occurrence. No further orders received.
This spontaneous report was received from a nurse and refers to a 22 year old female patient. No information about concomitant medication, concurrent conditions and medical history was provided. On an unspecified dates, the patient had received all three doses in the series of GARDASIL injection, (dose, frequency, lot # and expiration date not reported) for HPV prevention. On unspecified dates after the administration of GARDASIL, the patient experienced heavy and continous menstrual bleeding and pain during intercourse On an unspecified date, the patient sought medical attention, she visited unspecified physician. The physician performed a pap test on the patient and the results were positive for a mild case of HPV, (unspecified strain). The outcome of all events was not reported. The relatedness between GARDASIL adn all events was not specified by reporter. Additional information has been requested.
Also received STAMARIL (Adverse Report form submitted per protocol)-swollen lips, diff breathing, tachycardia, redness and itching of face-seen in ER with BENADRYL IV. Better today. Leaving on trip in AM.
This case was reported by a nurse via call center representative and described the occurrence of general physical health deterioration in a adult male patient who received FLUARIX QUADRIVALENT (batch number ZG3S5, expiry date 6th June 2017) for prophylaxis. In November 2016, the patient received FLUARIX QUADRIVALENT. On an unknown date, unknown after receiving FLUARIX QUADRIVALENT, the patient experienced general physical health deterioration. On an unknown date, the outcome of the general physical health deterioration was unknown. It was unknown if the reporter considered the general physical health deterioration to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The reported batch number ZG355 was corrected to ZG3S5 as per sales data review. The healthcare professional reported that, the patient received the FLUARIX QIV. After receiving the vaccine, the patient health deteriorated. The patient believed that it was from mercury in the medication. The letter was send to healthcare professional stating that, the FLUARIX does not contain thimerosal/mercury. No additional information was provided.
temperature excursion; received Comirnaty (orange cap) vaccines after the "excursion."; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), outcome "unknown", described as "temperature excursion"; POOR QUALITY PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "received Comirnaty (orange cap) vaccines after the "excursion."  Additional information: Physician Assistant calling to report a temperature excursion for Comirnaty (orange cap and gray cap) and stated all product was being stored under refrigeration and experienced a first time temperature excursion lasting 2 hours, 54 minutes and reaching a maximum temperature of 49.1 F. Seven children received Comirnaty (orange cap) vaccines after the "excursion."  The lot number for bnt162b2 was not provided and will be requested during follow up.
56 adults patients received doses after its expiration date Jul 13, 2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications are reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case (1 of 56 patient)
pt called 2JUL93 states broke out in hives 24hrs p/Hep B 1st dose; no sx of resp distress; hives all over body lasted 1-2 wks inc w/itching; did not see MD did not use anything ie DPH; states NKA to meds, Thimersol, yeast, seafoods;
has not been herself; bad diarrhea; chills; could not eat; feeling "very, very sick; general weakness; This is a spontaneous report from a contactable consumer. An 89-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from 11Jan2021 to 11Jan2021 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. It was reported that the patient has not been herself and having bad diarrhea, chills, and general weakness. It was also reported that the patient could not eat and was feeling very, very sick. The outcome of the events was unknown.  Information on lot/batch number has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 71-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Sep2023 at 12:00 as dose 1, single (Lot number: HH7595) at the age of 71 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 6 (BOOSTER); SINGLE, UNKNOWN MANUFACTURER), for Covid-19 Immunization; Covid-19 vaccine (DOSE 5 (BOOSTER); SINGLE, UNKNOWN MANUFACTURER), for Covid-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); SINGLE, UNKNOWN MANUFACTURER), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); SINGLE, UNKNOWN MANUFACTURER), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2; SINGLE, UNKNOWN MANUFACTURER), for Covid-19 Immunization; Covid-19 vaccine (DOSE 1; SINGLE, UNKNOWN MANUFACTURER), for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Oct2023 at 08:00, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Oct2023) Positive; (30Oct2023) Positive; (26Oct2023) Negative; (21Oct2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient received Paxlovid (lot number: GJ7161) from 21Oct2023, the first day patient had symptoms and tested positive, Both PCR and antigen test, completed five day doses dosage 25Oct2023. Symptoms improved by day two and three. Tested negative on 26Oct2023. Symptoms resumed early in the morning of 30Oct2023, and antigen tested with a strong positive. Patient had no Known allergies.
Dose given during routine follow up appointment was only 23 days after 1st dose.  Will be rescheduled to repeat dose 2 in 28 days.
Since age 20, I've been healthy.  Had the flu maybe 3 times (the last time 40 years ago), rarely caught a cold.  No health issues, other than blood pressure, controlled by Atenelol.  In April 2021, age 67 and 3/4, I got 2 Pfizer Covid vaccines, and have had constant health issues since:  Nasty colds, intestinal issues, skin problems, breast issues and most recently, liver issues.  These vaccines have clearly ruined my immune system.
Rash on entire body, erythema macules, no pustules, no vesicles.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 03Dec2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". Covid rebounded on 03Jul2022 (tested positive). Symptoms: congested, no fever or chills, aches. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment of COVID-19 included Paxlovid from 20Jun2022 to 25Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Heart/chest pain. Admitted to hospital, stay for 3+ days, blood tests completed, EkG, CT Scan, x-rays, ultrasound, other tests. Diagnosis of Pericarditis. Recurrent chest pain late July 2021.
Patient reports immediate "ill" feeling with Dizziness, vertigo, fever. Today presents with sudden onset moderate right sided sensorineural hearing loss
Rash, Pruritis, Erythema. A nurse reported the occurrence of a rash in a 46-year old male who was vaccinated with hepatitis A vaccine inactivated (Havrix) for prophylaxis. The subject's medical history included allergy to hydrocodone bitartrate/paracetamol (Vicodin). Surgical history included unspecified back operations. Concurrent medications were not specified. The subject experienced no adverse events following previous immunizations. On 24 January 2003, the subject received his first injection of Havrix. Two days post-immunization on 26 January 2003, he experienced a generalized rash "all over his body". The rash was red, "very" itchy and worse at night. The reporting nurse considered the events to be probably related to Havrix administration. The Havrix immunization series was discontinued. The outcomes of the rash was not reported.
Fever, chills, achy body for about 18 hours.  It has effected my period, causing it to be late, and have different symptoms that my usual regular period. My period is lighter, and almost having no symptoms at all. I am not pregnant.
Pt. reports her entire bicep area became red, warm to the touch; this lasted 24 hrs. No treatment.
The patient experienced small red maccular papular lesions on trunk and face. They also c/o a fever.
This spontaneous report as received from a medical assistant refers to a 4 month old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 19-OCT-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # R007988, expiry date: 16-OCT-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868:Original Case : 1809USA002868; US-009507513-1902USA009324:Original Case : 1902USA009323; US-009507513-1902USA009325:Original Case : 1902USA009323; US-009507513-1902USA009323:Original Case : 1902USA009323.
approx 18hr p/vax devel temp 100 & higher, limp, vomiting, bad h/a, light headedness, unable to stay awake, legs hurting, pale, sweaty, moist, couldn't stand to be touched APAP given;skin warm & pink, dry touch, alert;
only soreness in her arm.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (only soreness in her arm.) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026021F) for COVID-19 vaccination.     No Medical History information was reported.    On 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, the patient experienced PAIN IN EXTREMITY (only soreness in her arm.). At the time of the report, PAIN IN EXTREMITY (only soreness in her arm.) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were provided.  No treatment medications were reported.   This case was linked to MOD-2021-325385 (Patient Link).
Rec'd call from Patient 11/12/09.  She reported that at the time of the injection she felt the usual amount of pain but 3 hours later she could not lift her arm.  Had an appointment with Dr. for a turned left ankle 11/6/2008.  While there asked about shoulder.  Ultra sound fx's ordered.  Shoulder continues to hurt.
"Approximately 2 minutes after vaccination the 17 year old female had a "tonic seizure".  Became unresponsive for about 2 minutes. Mother reports daughter has a history of fainting/seizure after blood draws ("she's afraid of needles")" Patient left with family ambulating.
Patient received an expired dose of ACTHIB vaccine on 08/29/2023. Upon reconciling vaccine inventory, Nurse Manager, discovered that the vaccine inventory count was not correct. After further review it was discovered that the incorrect lot number was selected for a vaccine administered on 08/29/2023. The actual vaccine lot that was administered was ACTHIB lot UJ796AA that expired on 08/12/2023. Sanofi has been contacted to determine if ACTHIB lot UJ796AA was still viable on 08/29/2023 and their response was no. Attempted to contact patient's mother on 08/30/2023 at 3pm using in house interpreter. Patient's mother did not answer, voicemail was left. Will continue to call patient's mother until contact is made.
Mental state has changed since second dose. Alzheimer's symptoms have become very noticeably worse since second dose of Moderna Covid vaccine.
Numbness, lack of mobility, and stiffness in hands, wrists, and spreading up arms towards elbow.
Information has been received from an approximately 19 year old female patient with allergy to penicillin, CECLOR, AUGMENTING and erythromycin and not other pertinent medical history, who in 2005, "when she was 15 years old", was vaccinated with the first dose of GARDASIL (dose, route and lot number not provided). There was no concomitant therapy. On unknown dates, the patient received the 2nd and 3rd doses of GARDASIL (doses, routes and lot number not provided). On an unknown date, a DNA HPV test was performed and the result was positive for HPV type 16 after receiving all 3 doses of GARDASIL. The patient's outcome was unknown at the time of reporting. The patient sought unspecified medical attention. Additional information has been requested.
"Immunization given-15mins later while eyes were being examined child fell & hit head; MD checked everything fine; BP 120/80, p70;
I received my vaccine at 06:00pm and I had severe nausea and diarrhea about 5 minutes after the vaccine. I could see inflammation in my face and both arms.  I did not see a rash. But I got so dizzy. The set medic that was there advised me to drink water and take electrolytes. I called my doctor and he advised me to stay at the place where I was vaccinated until I felt better. I stayed for awhile because I felt so horrible.  After I got home I took the hydroxyzine and Benadryl and an extra Claritin.  I started to feel better at 10:15pm that night.
Swelling in the left hand the morning after the first shot and significant increase in blood pressure.  Ring finger on my left hand swollen to the point of fear of having to cut off ring.  I was able to get the ring off by soaking the left hand and using soap.  Swelling had not gone down within a few days.  Notified primary care Doctor on November 5 and a Neurologist on November 15.  Both advised it was safe to proceed with the second shot.  I did get the second shot on November 19.    Swelling seems to have increased after the second shot.  Blood pressure still elevated.
pt recv vax 19JAN99 & 6 days later pt devel fussiness & dec appetite & was not sleeping well;pt was seen by MD on 26JAN99 who noted pt was inconsolable;during abd exam pt arched back;28JAN99 pt began passing blood in stools;pt hosp;1/29/99 child diagnosed with intussusception.
Maculopapular rash on truck, UE, and LE sparing palms and soles, face and muscosal membrances. Itchy.
Chills; Body aches; Sore throat; Hot at the injection site; Itchy circle at the injection site; vaccination site erythema; This spontaneous case was reported by an other health care professional and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), VACCINATION SITE WARMTH (Hot at the injection site), VACCINATION SITE PRURITUS (Itchy circle at the injection site), VACCINATION SITE ERYTHEMA (vaccination site erythema) and CHILLS (Chills) in a 24-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.     No Medical History information was reported.    On 18-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 25-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), VACCINATION SITE WARMTH (Hot at the injection site), VACCINATION SITE PRURITUS (Itchy circle at the injection site), VACCINATION SITE ERYTHEMA (vaccination site erythema) and MYALGIA (Body aches). On 25-Feb-2021, the patient experienced CHILLS (Chills). The patient was treated with IBUPROFEN at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (Sore throat), VACCINATION SITE WARMTH (Hot at the injection site), VACCINATION SITE PRURITUS (Itchy circle at the injection site), VACCINATION SITE ERYTHEMA (vaccination site erythema), CHILLS (Chills) and MYALGIA (Body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
THE PATIENT PRESENT INFLAMATION IN THE FOREHEAD (IN THE CENTER) AND PASSAGE TO THE EYES, EYELIDS, NOSE, CHEEKS, LIPS AND NECK. IMMOBILITY OF THE LEFT ARM AND EDEMA IN THE PUNCTURE AREA. REQUIRED TREATMENT WITH PREDNISONE, LEVOPHED, FERROUS SULFATE, AUGMENTIN. HE WAS ON MECHANICAL VENTILATOR FROM MARCH 6, 2022 TO MARCH 23, 2022.
On 5/10/2021, I woke up with deep muscle aches, waves of chills, overall fatigue and malaise, and a bad headache. That evening, at approximately 7:30-8pm, I suddenly got very lightheaded while sitting at the table. Then my heart started racing out of no where. Intense pain rose in the center of my chest and radiated down both of my arms, before I went completely limp. My husband reports that one minute, I was somewhat responsive, and the next I wasn't responding at all. He had to hold me up from falling out of the chair and immediately called 911. He said my head flopped lifelessly while they transported me, in a chair with straps, into the ambulance. I started to come to after a while, but had generalized weakness that slowly wore off. The attending physician said that I either had an adverse reaction to the Pfizer vaccine, or the vaccine and my migraine med (Ubrelvy) had a bad interaction with one another. I was treated with IV fluids (NACI) and injected with a dose of Toradol.
Info regarding Prevnar injection was received from a consumer regarding a 4 year old male pt who received Prevnar without parental knowledge. He reportedly would not eat for 3 days and developed diarrhea. At 4 years of age, the pt received the first dose on 8/12/05. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 8/12/05. Dose regimen was 1 dose, IM. Event Details: A mother reported that on 8/12/05, her son received Prevnar (first dose) without her knowledge (drug administration error). On 8/13/05, he developed diarrhea and would not eat (decreased appetite). She gave the child a "brat diet". The child's BCP was contacted and no further treatment was prescribed. On 8/15/05, all symptoms had abated. No additional info was available at the time of this report.
fever 104-2 days; swelling of lt side of face vomiting, diarrha; rash all over thigh where shot was given no appetite, crying;
Fatigue started on Day 10.  Fever Day 11-12 (as high as 102.3).  Fatigue through day 15.  Rash on left art at injection site day 15.  Severe headache on day 11. Mild nausea on day 12.
Headache, malaise (expected); developed eye pain, localized to left eye; saw ophthalmologist, no dx on 10/28/15. Developed shingles rash, blistering scalp, forehead, nose, around left eye by 11/3/15 saw PCP and ophthalmologist again, Dx rx - 7 days valacyclovir. PCP 11/3 3 dr visits: 10/28/15 and 11/3/15 and consulted w/neurologist 11/3/15.
On5/18/22, during a follow up call, the donor disclosed to the center that she experienced a migraine the day after she received her Hepatitis B immunization. She had not experienced any reactions following her first Hepatitis B immunization. She stated that following the second Hep B immunization she had a migraine where she had to close her eyes and that it would come and go and had been experiencing it for a week.
Ringing in my ears; It's not horrible but it's irritating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 40 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Aug2021 15:15 (Lot number: FC3183) at the age of 40 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: TINNITUS (non-serious) with onset 18Aug2021 15:30, outcome "not recovered", described as "Ringing in my ears"; IRRITABILITY (non-serious) with onset 18Aug2021, outcome "unknown", described as "It's not horrible but it's irritating". Therapeutic measures were not taken as a result of tinnitus.  Additional information: Patient got first dose on Wednesday last week and 4 hours later I had ringing in my ears. Patient thought it would go away the next day and it didn't. It was not gone away. It's like shooting a gun without ear protection. It's not horrible but it's irritating. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not received any treatment for the events.  No follow-up attempts are possible. No further information is expected.
Pt recvd vax on 23OCT90; next day pt's arm was red, swollen & tender; To MD offic 26OCT90 & dx of cellulitis made; tx Duricef; Lab eval revealed gram-negative rods; By 14NOV90 pt recovered;
pt recv vax;2 days p/ vaccine,pt recv allergy shot & exp cramping,vomiting & d;
Swelling and redness on the site of injection the day after. Forming a big ring and so itchy. Patient took some BENADRYL today and felt better.