chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 46-year-old patient received BNT162b2 (BNT162B2), on 02Oct2021 as dose number unknown, single (Lot number: FC3182) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 30Aug2022, outcome "not recovered", described as "Covid rebound following Paxlovid. Tested positive 2 days after negative test and am still positive 5 days out from the original positive rebound test"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (2022) Negative, notes: Tested positive 2 days after negative; (2022) Positive, notes: still positive 5 days out from the original positive rebound test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were not taken as a result of disease recurrence. Clinical Information: Adverse event: Patient started Paxlovid on 20Aug2022 for Covid 19 Treatment and stop on 25Aug2022. Covid rebound following Paxlovid. Tested positive 2 days after negative test and was still positive 5 days out from the original positive rebound test. Adverse event start date was 30Aug2022. Adverse event resulted in None of the above. Patient was not recovered. Taken no treatment for AE. Other medical history: Diabetes, high blood pressure, high cholesterol.
Initial information received on 29-Aug-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case 17 years old male patient who was vaccinated with a 0.5 ml expired dose of vaccine MENACTRA (Batch number: U5416AB, expiration date: 20-Oct-2017), via intramuscular route in Left arm 28-Aug-2018. The patients medical history and concomitant medications were not reported. It was an actual medication error due to expired vaccine used. No AE symptoms were reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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. List of documents held by sender: none.
Covid test result was positive; Covid test result was positive; This is a spontaneous report from a contactable health professional (patient).   This 56-year-old male Health Professional(patient) reported for himself who received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EL3247), via intramuscular route, administered in left arm on 03Feb2021 (at the age of 55-years-old), as dose 1, single for covid-19 immunization and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EL3247), via intramuscular route, administered in left arm on 02Mar2021 (at the age of 55-years-old), as dose 2, single for covid-19 immunization at workplace clinic facility. Medical history included benign prostatic hyperplasia (BHP). Known allergies were reported as no. The patient's concomitant medication was not provided. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient did not have any other medications within 2 weeks of vaccination. On 18Sep2021 at 13:00, patient experienced sneezing, running nose and aching. On 19Sep2021, patient underwent lab tests and procedures which included Binax nasal swab test which resulted in positive COVID-19. Therapeutic measures were reported as no. The outcome of the event Covid test result was positive was reported as not recovered and other event was unknown.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Vaccination Failure and Covid 19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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.
Soreness in arm at injection site (no red-inflame - or reaction at site - just sore).
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown ages and genders who were vaccinated with an improperly stored doses of ROTATEQ (lot # reported as K007247, expiration date 30-MAR-2016 or Lot # K008140, expiration date 28-APR-2016, oral) (dose not reported) on either 29-MAR-2015 or 30-MAR-2015. No adverse effect reported. It was unknown if the patients sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Patient was under-dosed and given 0.25mL rather than the required 0.5mL dosage
Initial vaccine gien on 7/25/2008.Redness and warmth with induration reported on 7/30/2008. Initially fine first 4 days, 5th day several small red raised areas, itching and swelling (soft), some pain with palpation. Diphenhydramine and cold packs evening and next day. By 4 pm on 7/31 area is red and indurated 7 cm in diameter. Afebrile, no itching but tender to palpation. Started on Medrol dose pack.
pt recvd vax & 45 mins later exp cyanosis of lt arm from inject site down; lt arm was cool to touch; 16SEP93 arm & hand were observed & found to be nl in color & temp;
Left deltoid swollen, hard, hot & red where vaccine given.  6 cm / 5 1/2 cm.  Circ. 23 cm.
feeling unwell, soreness in arm, fever, tiredness, achy, this lasted from 5pm that night and still feeling them over 36 hours later.
On 9/21/2011 I received an New Hire Employee workup. I rec'd a TB skin test on my left forearm, the site became immediately bruised. I then received a Tetanus shot in my right arm the injection stinged a little. Later in the day I received a Flu shot at employee health. Later in the evening when I got home I noticed my skin became itchy and later I developed welps and my skin was hot and red it appeared on my legs, arms, back and stomach. I presented on Thursday, 9/22/11 to my employee immediate care for medical attention. They administered a dose of Benadryl intramuscular and sent me home for a few days ordering me to take 50 mg of Benadryl often. On Friday, 9/23/11 around 11 am, I represented to the Employee Health Suite to have the TB results read. They were negative..but I still have a bruise at the injection site. Friday, 9/23/11 around 1:00 AM, I presented to the ER due to severe itching. They prescribed me a 6 day dose of MethylPrednisolone Tablets 4 mg taper. To-date, I am still itchy and have red welps on my entire body.
DECREASED APPETITE; FLU LIKE SYMPTOMS; COLD CHILLS; TIREDNESS; INJECTION SITE PAIN; HEADACHE; This spontaneous report received from a patient concerned a 56 year old female. The patient's weight was 170 pounds, and height was 165.1 centimeters. The patient's concurrent conditions included alcohol user, and non smoker, and other pre-existing medical conditions included no medical history. The patient did not have any history of vaccine allergy, drug abuse and did not have acute illness 30 days prior to vaccination. The patient did not have significant family history of diseases or hospitalizations. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 13:08 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced cold chills. On 11-MAR-2021, the subject experienced tiredness. On 11-MAR-2021, the subject experienced injection site pain. On 11-MAR-2021, the subject experienced headache. On 11-MAR-2021 20:00, the subject experienced flu like symptoms. On 12-MAR-2021, the subject experienced decreased appetite. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 12-MAR-2021, was recovering from cold chills, and flu like symptoms, and had not recovered from decreased appetite, tiredness, and injection site pain. This report was non-serious.; Sender's Comments: v0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
Chills, mild headache, racing heart all night long, couldn?t sleep as a result.
03/01/23 presents to ED for "shortness of breath". PMHx of "CLL, emphysema, COPD, s/p rectal cancer 2022"
Information has been received from a physician's business manager referring to 2 patients of unknown age and gender. The patients' drug reactions/allergies and pertinent medical history were not reported. On unspecified dates from 03-MAR-2015 to 15-APR-2015, the patients were vaccinated with (Oka/Merck) VARIVAX (dose, frequency, route and lot # were not reported) which were improperly stored. No symptoms were reported. Additional information has been requested.
Nine days after shot, what looked like rash developed and then moved into my mouth as blood blisters. Went to emergency room; blood test showed blood platelet level at 1000. Hospitalized and given Gamma Globulin intravenously, Prednisone and Ranitidine. Was discharged early because of no insurance when platelet level had reached 16000. I am now being seen as an outpatient. Medical records state hematoma. msv
Per parent report within 4-6 hrs after immunization began having SOB and blurred vision. Sx self resolved with intervention.
I never got Covid, UNTIL 26May; I never got Covid, UNTIL 26May; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) 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) all with onset 26May2023, outcome "unknown" and all described as "I never got Covid, UNTIL 26May". The patient believed the patient was part of the survey that ended in April or early May this year, the patient never got Covid, Until 26May. Since the survey ended, The patient was unable to report it. + (positive) Covid test, The patient stated. "Grateful I was vaccinated including the bivalent." The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300290740 same patient/drug, different dose/event;
pt recv vax; a few mins p/ vax, pt asleep & noted to be flaccid & unable to awaken; pt had similar episode in past associated vax;
On the night of 1/13 she developed an itchy maculopapular rash on her bilateral arms and the back of her neck. She is also complaining of a burning sensation. Recent med changes include taking gabapentin and Augmentin starting 1/6, but she has taken these medications in the past and did not report developing a rash when on these meds before
Developed a rash after first typhoid oral pill. Rash disappeared after several hours. No rash appeared with subsequent doses, though a low grade fever (99.6) developed an hour after administration of the second pill. It disappeared with ibuprofen.
Covid arm- onset 7 days post vaccine.  Onset of chills followed by covid arm with large area ( approx. 6? in length and almost circumferential around entire arm) of redness and itch, heat .  Redness and itch persisting for a week- redness just starting to decrease 8 days after onset.
Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04AP21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and High cholesterol.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication includes Blood pressure and Cholesterol medications.
On 01/08/2001 the patient developed a "rash like chicken pox" on his legs and back. The school nurse reports that many children in the school currently have Varicella. The patient's brother had a similar experience following exposure to varicella virus vaccine live. Follow up has been received from a physician who reports the patient information given is not enough for him to identify the patient. No further information is expected.
Approx 2 hr after Flu shot, pt started itching on her neck and arms, a red rash then developed and continued to itch. No prob with breathing but thought she might have hives on the back of her neck. called Dr - took BENADRYL and rash disappeared along with itching the same night.
patient states that the day after immunization her vision is blurry for both near and far vision.  I told patient that I will contact her later today and if not any better, that she would need to seek medical attention
High fever up to 104 for 48 hours, severe body aches, migraine, severe hot cold chills, extreme fatigue,  body shaking constantly extremely sore arm. Started 6 hours after shot
low-grade fever; mild to intense headache; muscles soreness; fatigue; on and off sweats; chills; difficulty sleeping; mild soreness at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient received BNT162b2 (BNT162B2), on 19Nov2021 at 10:45 as dose 3 (booster), single (Lot number: FH8030) at the age of 27 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: BLISOVI 24 FE oral taken for contraception, start date: 2018 (ongoing). Vaccination history included: BNT162b2 (DOSE 1; Lot number: EL3247; 10:00 in right arm), administration date: 04Mar2021, when the patient was 26-year-old, for COVID-19 immunization, reaction(s): "low-grade fever", "mild to intense headache", "muscles soreness", "fatigue", "on and off sweats", "chills", "difficulty sleeping", "mild soreness at the injection site"; BNT162b2 (DOSE 2; Lot number: EP6955; 09:30 in right arm), administration date: 25Mar2021, when the patient was 26-year-old, for COVID-19 immunization, reaction(s): "low-grade fever", "mild to intense headache", "muscles soreness", "fatigue", "on and off sweats", "chills", "difficulty sleeping", "mild soreness at the injection site". The following information was reported: CHILLS (non-serious) with onset 19Nov2021 at 21:00, outcome "recovered"; INSOMNIA (non-serious) with onset 19Nov2021 at 21:00, outcome "recovered", described as "difficulty sleeping"; FATIGUE (non-serious) with onset 19Nov2021 at 21:00, outcome "recovered"; PYREXIA (non-serious) with onset 19Nov2021 at 21:00, outcome "recovered", described as "low-grade fever"; VACCINATION SITE PAIN (non-serious) with onset 19Nov2021 at 21:00, outcome "recovered", described as "mild soreness at the injection site"; HEADACHE (non-serious) with onset 19Nov2021 at 21:00, outcome "recovered", described as "mild to intense headache"; MYALGIA (non-serious) with onset 19Nov2021 at 21:00, outcome "recovered", described as "muscles soreness"; HYPERHIDROSIS (non-serious) with onset 19Nov2021 at 21:00, outcome "recovered", described as "on and off sweats". Therapeutic measures were taken as a result of pyrexia, headache, myalgia, fatigue, hyperhidrosis, chills, vaccination site pain.  Additional information: Following vaccination (primary dose, second dose, and both boosters),  the patient experienced a low-grade fever, mild to intense headache, muscles soreness and fatigue, on and off sweats/chills, difficulty sleeping due to side effects after getting the vaccine, and mild soreness at the injection site. The onset of side effects began in the evening and continued through the night and into the next day. The patient recalls that the side effects following the 3rd (booster) dose were the most severe and lasted more than 24 hours. She took acetaminophen in all instances as recommended and recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300029954 same patient/events, different dose;US-PFIZER INC-2021336635 same patient/events, different dose;
Information has been received from a physician concerning a 7 year old male with autism who on 02/26/98 was vaccinated with varicella virus vaccine live (Lot # 624450/1423E).  On 02/14/04 the pt developed a varicella rash with 10 vesicular lesions and a sore throat. There was no fever or URI symptoms. The pt sought unspecified medical attention. There was no product quality complaint involved. The pt recovered. It was noted that the pt did not experience any adverse symptoms following prior vaccinations. There were no relevant diagnostic tests or lab data. Additional information has been requested.
Allergic reaction within 20 minutes went to ER. Treated then back to the ER several times then admitted to the hospital for two days. Treatedd with 125 mg. Prednisone IV and zantac and bendryl. Ended up back at ER and admitted again for two days Tremors horrible headache treated with antibiotic had spinal tap done. Still Having allergic reaction 10 weeks later. Still on prednisone bendryl and zantac. Still having allergic reation. Red burning face itching, swollen neck face and throat. Tremors still, and cant swallow sometimes, blurry vision. I was given the HPV Vaccine by accident then given the flu shot right after. I was supposed two have the flu shot only.  12/28/07 Reviewed hospital ER medical records of 10/2/2007 which reveal patient experienced facial swelling, redness, itchy skin, dizziness, anxiety & dyspnea x 1 day.  Tx w/steroids & antihistamine.  Improved & d/c to home. FINAL DX: allergic reaction w/angioedema & bronchospasm, secondary to drug.
Fever, myalgia (neck and mid back pain) - onset 24 hours after vaccine. Headache 2 days later. Fever up to 103 degrees. Symptoms lasted 6 days.
Swelling for 3 weeks.; Warm to touch; Required felt malaise for minimum three days; This case was reported by a other health professional via sales rep and described the occurrence of swelling in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced swelling, skin warm and malaise. On an unknown date, the outcome of the swelling, skin warm and malaise were unknown.   It was unknown if the reporter considered the swelling, skin warm and malaise to be related to Shingrix.     Additional Information: GSK Receipt Date: 26-APR-2022 Reporter's Comments: The patient was reported swelling for 3 weeks and Warm to touch and required felt malaise for minimum three days. The reporter did not give consented to follow up.
No additional AE/PQC reported.; Nurse calling to report adverse event regarding an administration of an expired dose of MMR II.  Nurse stated that the MMR II dose had a labeled lot / expiry of U031359 10/7/2023, and the dose was inadvertently administered on 10/11/2023.  Nurse conf; This spontaneous report was received from Other Health Professional and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 11-OCT-2023, the patient started therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 0.5 ml / two dose series, lot #U031359, expiration date: 07-OCT-2023, administered for prophylaxis (strength, and route of administration were not provided).  On 07-OCT-2023, Nurse called to report adverse event regarding an administration of an expired dose of MMR II.  Nurse stated that the MMR II dose had a labeled lot / expiry of U031359 07-OCT-2023, and the dose was inadvertently administered on 11-OCT-2023. Nurse confirmed this was the patient's first dose in the series, and that the patient has not reported any medical concerns or symptoms due to being administered the expired dose of MMR II. No additional information provided regarding this adverse event. Nurse consents to correspondence regarding this adverse event. Case number provided. No additional AE/PQC reported.
Patient called the pharmacy stating that she had a fever (101 F), diarrhea, and a sore arm after receiving her second Pfizer COVID-19 vaccine on 2/26/21