chrisvoncsefalvay/vaers-outcomes huggingface dataset:
white spots forming on arm post vaccine injection; This is a spontaneous report from a contactable Pharmacist (patient) via a manufacturer sales representative.   A patient of unknown age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unknown date at single dose for COVID-19 immunisation. Medical history and concomitant medications were none. The patient complains of white spots forming on arm post vaccine injection of first dose. Outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
nurse failed to mix the powder substance with the liquid before injecting the patient with Pentacel vaccine and HIB portion was not received, with no adverse event; nurse failed to mix the powder substance with the liquid before injecting the patient with Pentacel vaccine, with no adverse event; Initial and additional information received on 26-Feb-2021 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a two years old female patient who's nurse failed to mix the powder substance with the liquid before injecting the patient with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] dose: 0.5 ml (batch number and expiry date not reported) via an unknown route in unknown administration site on an unknown date in Dec-2020 for prophylactic vaccination and HIB portion of the vaccine was not received by the patient (product preparation issue and wrong technique in product usage process)  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   It was an actual medication error due to inappropriate reconstitution technique and wrong injection technique (latency: same day).  Potential Product Technique Complain: No. Description: The caller would like to know how to proceed in caring for the patient. The caller would like to know the effects this will have on his daughter and how to proceed to ensure that she has the complete vaccine. Reporter relationship: Caregiver. Product used. Caller is consumer father and he is calling back to update information for potential Adverse event (AE) 00495357. Caller providing additional information for previously reported AE (00495357) to provide nurse practitioner.  At the time of reporting no adverse event was 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 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.  There will be no information on the batch number for this case.
Tdap vaccine given - Men B should have been given. Client also received Meningococcal Conj and HPV9.
Resident developed and was being treated for pneumonia on  or about  February 14, 2021, He was admitted to hospital on March 6, 2021 for low potassium and returned to the facility about March 11,2021. He returned with a diagnosis of pneumonia. He was admitted hospital on 4-1-2021 and returned to the facility on 4-7-2021 with a diagnosis of CVA. He was admitted to hospital again on 4-12-2021 with a diagnosis of aspiration pneumonia. He returned to the facility on 4-21-2021 and expired at the facility on 4-26-2021
2 month old male accompanied by parents with upper respiratory infection symptoms x 1 days.  Per parents, patient went at 10:45 AM today to get vaccine shots and then subsequently got a fever. Symptoms viewed as moderate by parents. Better with nothing, worse with nothing.  No history of other contacts with same symptoms. No travel.
Patient came in for routine 15 month wellness visit. While reviewing the vaccines with the patient's parents, recommended the next dose of the COVID-19 vaccine.  The immunization records furnished to our office demonstrated that had received only two COVID-19 Pfizer 6mo-<4 yrs monovalent vaccines, so verbally confirmed this with the mother. Mother verbally confirmed that child had received two COVID-19 vaccines. So recommended the next dose which is now the COVID-19 Pfizer 6mo-<4yrs bivalent booster.  After the visit was completed, mother called our office to inform us that had actually already received a third Pfizer 6mo-<4yrs monovalent vaccine, so she was not due. Dr. called the mother to review the vaccine administration error. It was found that had a completely different mother's maiden name attached to record and so not all the immunizations could be retrieved on our system. We are working to resolve this issue and correct the patient's immunization records.
Was getting flu symptoms every year with the flu shot; Initial information regarding this unsolicited valid non-serious case received from a consumer (patient) via social media, public post on the Sanofi flu shot campaign The Race to 200M on 12-Nov-2020.  This case involved an unknown demographic patient who reported that the patient was getting flu symptoms every year with the flu shot (Influenza), while received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, vaccination and family history of the patient were not provided. Concomitant medication was not reported.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date (unknown latency), the patient was getting flu symptoms every year with the flu shot (Influenza), while received vaccine INFLUENZA VACCINE.   No relevant laboratory test was reported.  It was not reported if the patient received a corrective treatment.  The outcome was reported as unknown.
Pfizer covid 19 Bio Tech vaccine administered at 11:20 am. At 11:40 am I began feeling odd- fuzzy and light headed. Ears began to ring loudly. Lips became tingly and numb. Throat and tongue became tingly and numb. At 11:50 we had returned to clinic. 50 milligrams of Benadryl were administered. Blood pressure 120 over 60 (a bit high for me but anxiety accounts for that) . Pulse 60- normal for me. After being observed for one hour symptoms diminished and we left clinic. After 2 more hours all symptoms gone.
Pain and weakness in the left arm from where vaccine was administered, she feels it about one third of the way down from her shoulder to her elbow, no elevated temperature or inflammation, no improvement in symptoms over time.
BODY ACHE/PAIN; ITCHY EYES; SKIN SENSITIVE TO TOUCH; FLU LIKE SYMPTOMS; CHILLS; GENERAL JOINT PAIN; MILD HEADACHE; FEELING TIRED; This spontaneous report received from a patient concerned a 48 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 01808978, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 14:00 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced body ache/pain. On 03-APR-2021, the subject experienced itchy eyes. On 03-APR-2021, the subject experienced skin sensitive to touch. On 03-APR-2021, the subject experienced mild headache. On 03-APR-2021, the subject experienced chills. On 03-APR-2021, the subject experienced feeling tired. On 03-APR-2021, the subject experienced flu like symptoms. On 03-APR-2021, the subject experienced general joint pain. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache/pain, itchy eyes, skin sensitive to touch, mild headache, chills, flu like symptoms, and general joint pain, and was recovering from feeling tired. This report was non-serious.
This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. Information about medical history or concurrent conditions was not provided. On 22-DEC-2014 the patient was vaccinated with an incorrect stored dose of GARDASIL 0.5 ml, intramuscular injection (frequency, lot number and expiration date were not provided), which had underwent a temperature excursion. Concomitant medications were not reported. No adverse effect was reported and there was no product quality complaint involved. This is one of several reports received from the same source. Additional information has been requested.
had my second shot and still not feel right including cramping and dizziness; had my second shot and still not feel right including cramping and dizziness; had my second shot and still not feel right including cramping and dizziness; still spotting; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (had my second shot and still not feel right including cramping and dizziness), DIZZINESS (had my second shot and still not feel right including cramping and dizziness), MALAISE (had my second shot and still not feel right including cramping and dizziness) and INTERMENSTRUAL BLEEDING (still spotting) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (had my second shot and still not feel right including cramping and dizziness), DIZZINESS (had my second shot and still not feel right including cramping and dizziness), MALAISE (had my second shot and still not feel right including cramping and dizziness) and INTERMENSTRUAL BLEEDING (still spotting). At the time of the report, MUSCLE SPASMS (had my second shot and still not feel right including cramping and dizziness), DIZZINESS (had my second shot and still not feel right including cramping and dizziness) and INTERMENSTRUAL BLEEDING (still spotting) had not resolved and MALAISE (had my second shot and still not feel right including cramping and dizziness) outcome was unknown.            The concomitant medication was not reported. The treatment history was not reported.   This case was linked to (Patient Link).
This spontaneous report was received from a pharmacist refers to a 60 year old male patient. No drug reaction were reported. The patient previously received PNEUMOVAX23 on 09-APR-2013 and no adverse reaction were reported. On 28-AUG-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J003798, expiry: 28-JUN-2014). On 30-AUG-2013 (reported as 2 to 3 days after vaccination), the patient developed an injection site reaction and rash following vaccination with ZOSTAVAX. The pharmacist reported that the injection site reaction which developed about 2 to 3 days after the vaccination. The injection site reaction was described initially as a red area at the injection site, which after a couple of days developed into a half-moon shape with raised bumps inside the half-moon shape, described as a rash (pharmacist had a photo of the adverse reaction site). The patient was instructed to use ice packs on the injection site as a treatment. The pharmacist reported that the patient went to see his physician today (name of physician unspecified). The outcome of the events were reported as not recovered. This is 1 of 2 reports received from the same reporter. Additional information has been requested.
39 year old patient who received Arexvy while pregnant; Live birth; 39 year old patient who received Arexvy while pregnant; This non-serious retrospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a 39-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: 39 year old patient who received Arexvy while pregnant), live birth (Verbatim: Live birth) and inappropriate age at vaccine administration (Verbatim: 39 year old patient who received Arexvy while pregnant). The outcome of the vaccine exposure during pregnancy, live birth and inappropriate age at vaccine administration were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Live neonate with no apparent congenital anomaly   Additional Information: GSK receipt date: 13-Nov-2023 Pharmacist had a patient who received Arexvy while pregnant (no date was available).  She already delivered and nursing the patient. No other details were available. Did not consent to follow-up. The pregnant patient received a dose of Arexvy at an inappropriate age, which led to vaccine exposure during pregnancy, inappropriate age at vaccine administration.
Loss of appetite; Slight muscle ache; Little bit of sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: DECREASED APPETITE (non-serious), outcome "unknown", described as "Loss of appetite"; MYALGIA (non-serious), outcome "unknown", described as "Slight muscle ache"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Little bit of sore arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This is a spontaneous report from a contactable nurse. A female patient of unknown age and race/ethnicity received first dose of TRUMENBA at single dose on an unknown date. Medical history and concomitant medications were not reported. After vaccination, on an unknown date, the patient became very rigid, almost like they were having a seizure (not just like a regular syncopal episode). The patient was not going to receive the second dose. The patient was currently in clinic. Her mother would like to know how effective it is going to be with her just getting the one dose of meningococcal group b rlp2086. Outcome was unknown. Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
FATIGUE, JOINT PAIN IN SHOULDERS, NECK, LUMBAR.  NUMBNESS IN ARMS, HANDS, LEGS, HEADACHE, NIGHT SWEATS., BLOOD IN URINE  DIAGNOSED WITH AUTOIMMUNE,  SERUM SICKNESS RELATED TO SHRINGRIX VAC.  2ND DOSE NOT ADMINISTERED. STERIOD AND HYDROCODINE PERSCRIBED.  SYMPTOMS SUBSIDED 8 MONTHS.
SORE ARM; This spontaneous report received from a patient concerned a 71-year-old elderly female. The patient's height, and weight were not reported.  The patient's past medical history included: tumors, hysterectomy, and breast surgery (SX), and concurrent conditions included: hypertension (HTN), arthritis, neurological issues, tendonitis, iodine allergy, red dye allergy, sulfa drugs allergy, mold allergy, seasonal allergies, some trees allergy, non-smoker, and non-alcoholic, and other pre-existing medical conditions included there was no drug abuse or illicit drug usage. Past medications were not reported. The patient previously received covid-19 vaccine ad26.cov2.s  (manufacturer unknown) (suspension for injection, route of admin, batch number: Unknown and expiry: unknown) 1 total, dose not reported, start therapy date were not reported for prophylactic vaccination (dose number in series 1). It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). No concomitant medications were reported. The patient received booster covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, and expiry: 20-MAR-2022) 1 total, dose was not reported, administered at right arm on 18-NOV-2021 for prophylactic vaccination (dose number in series 2).  On 18-NOV-2021, the patient experienced sore arm (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 25-NOV-2021. This report was non-serious. This case, from the same reporter is linked to 20211233315.
Dose administered post the expiration or beyond use date; The vials were placed in refrigerator on 17-May-2022 and administred on 19-May-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) and PRODUCT STORAGE ERROR (The vials were placed in refrigerator on 17-May-2022 and administred on 19-May-2022) in a 67-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 003K21-2A, 013L20A, 030M20A and 058F21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Blood pressure high.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) .5 milliliter. On 16-Feb-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to .5 milliliter. On 30-Oct-2021, received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to .25 milliliter. On 19-May-2022 at 2:10 PM, received fourth dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .25 milliliter. In May 2022, the patient experienced PRODUCT STORAGE ERROR (The vials were placed in refrigerator on 17-May-2022 and administred on 19-May-2022). On 19-May-2022 at 2:10 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) and PRODUCT STORAGE ERROR (The vials were placed in refrigerator on 17-May-2022 and administred on 19-May-2022) outcome was unknown.        For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (The vials were placed in refrigerator on 17-May-2022 and administred on 19-May-2022).    No concomitant medications was reported.  The medical history included Yodo.  The patient had no known allergies. It was unknown if the patient was diagnosed or tested positive for COVID-19. Also unknown if the patient had acute illnesses at the time of vaccination and up to one month before and unknown if prescriptions, over-the-counter medications, dietary supplements or herbal remedies were taken at time of vaccination and/or at the time of the adverse event. It was also unknown if the patient had experienced a similar event in the past.  The vaccines expired on 13-May-2022 and administered on 19-May-2022. The vials were placed in refrigerator on 17-May-2022.  No treatment drug details was reported.
Pt received Bexsero in left deltoid on 5/8/19 at 11:30 AM. On 5/8/19 at 5 PM pt started experiencing moderate to severe pain at injection site. redness, and swelling about the size of a half dollar. Pt also complains of itchy throat and itchy arms (bilateral). Pt received Benadryl and prednisone in the office. Pt was sent home with Rx of prednisone and hydroxyzine.
After the fourth injection, two weeks later I developed very high blood pressure. The pressure reading was 200 or above. We went to the emergency room immediately after we decided that the blood pressure was not coming down. I felt nauseous, some pain in my jaw, and pain on the left side of my face. After many different tests performed at the hospital, it was determined that I suffered a heart attack. The EKG was normal upon arrival at the hospital. A cauterization was performed to check my heart for any damage as a result of the cardiac event. The cauterization was normal with some evidence of plaque buildup as a result of age only. No significant issues were determined. I am currently on blood pressure medication, clothing medication, baby aspirin, and blood thinners. Medications that I have never taken.
Patient received Pfizer vac and booster, then second booster with Moderna vax.  He developed chest pain and shortness of breath three weeks later, then hemoptysis.  Large pulmonary embolism found on ED evaluation
Diarrhea; Tiredness; Redness around injection site; This spontaneous case was reported by a nurse and describes the occurrence of DIARRHOEA (Diarrhea), FATIGUE (Tiredness) and VACCINATION SITE ERYTHEMA (Redness around injection site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), FATIGUE (Tiredness) and VACCINATION SITE ERYTHEMA (Redness around injection site). On 23-Jan-2021, DIARRHOEA (Diarrhea) and FATIGUE (Tiredness) had resolved. On 28-Jan-2021, VACCINATION SITE ERYTHEMA (Redness around injection site) had resolved. Possible      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.
Information has been received from a nurse concerning a 4 year old male patient with an egg allergy who on 03APR2001 was vaccinated with measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live. Secondary suspect therapy included varicella virus vaccine live which was administered on 03APR2001 and hepatitis B vaccine rHBsAg (yeast) + Hib conj vaccine which was administered on 13APR2001. In November 2003, the patient presented with a generalized rash over his body. There were no other symptoms present and no treatment was required. Subsequently, within one week time, the patient's generalized rash resolved. The nurse also stated that the patient was not vaccinated at their office. No product quality complaint involved. Upon follow up a nurse indicated that "we do not have records for original event. Only by mothers report. I have contacted family practice, pediatrics and public health, no one claims to have any documentation regarding reaction during primary series as reported." No further information is available.
Low grade fever, body aches, one episode of vomiting, slight headache and eye sensitivity  Swabbed 12/31/2020 COVID positive 1/2/2021
Experienced pruritis and urticarial rash 2 weeks following Moderna booster. Symptoms periodic throughout the day, worsened with hot shower. Areas scratched would develop urticaria. Area on upper thigh consistently symptomatic and developed allopecia of leg hair. Symptoms treated with oral antihistamine. Symptoms wained over the course of 6 months.