chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Info has been received from an RN concerning a 5 year old male pt with no allergies and no pertinent medical history, who immigrated from another country, who on 8/1/05 was vaccinated with a dose of varicella virus vaccine live. On 8/18/05, the pt had a titer drawn which showed varicella antibody response failure. It was also noted that the same child was vaccinated with a 2nd, IM, dose of MMRII (lot 649241/0032R) on 7/18/05 and failed to seroconvert for mumps. There was no illness at the time of vaccination and no adverse events following prior vaccination. There was no product quality complaint reported. The pt sought unspecified medical attention. Additional info is not expected.
Initial unsolicited report received from a Nurse (LPN) on 21-May-2018. This case involves a patient (age and gender was not reported), who was vaccinated with an expired dose of ADACEL (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. It was a case of actual medication error due to expired vaccine used because one expired dose was given to the patient. 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 holder's 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. Documents held by sender: none
Pt felt warm and face felt tingly. drank water and ate snacks, felt better after resting a few minutes
Guillain-Barre Syndrome/acute infective polyneuritis; acute inflammatory demyelinating polyneuropathy; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a male patient of unknown age. His concurrent conditions, medical history and concomitant medications were not provided. In or around 04-MAR-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dose, injection anatomical location and route of administration were not reported), for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), he suffered progressive weakness in his lower extremities and shortness of breath as well as upper extremity symptoms. The patient was hospitalized and diagnosed with Guillain-Barre Syndrome/acute infective polyneuritis and acute inflammatory demyelinating polyneuropathy (demyelinating polyneuropathy). As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX), his symptoms had resulted in physical limitations not present prior to using the vaccine. He also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, he suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, he had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome for the events was not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  It was considered by the reporter that demyelinating polyneuropathy and Guillain-Barre Syndrome were disabling events.  Upon internal review, the demyelinating polyneuropathy and Guillain-Barre Syndrome were medically significant events.
COVID-19; Catching cold; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (COVID-19) and NASOPHARYNGITIS (Catching cold) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced SUSPECTED COVID-19 (COVID-19) and NASOPHARYNGITIS (Catching cold). At the time of the report, SUSPECTED COVID-19 (COVID-19) and NASOPHARYNGITIS (Catching cold) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Feb-2021, SARS-CoV-2 antibody test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment: got infusion in hospital.before he left, he was told he tested negative for COVID-19   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow-up received on 15-06-2021: Lab data  was added,
Patient waited the 15 minute time frame no symptoms or signs, patient was well and no swelling in area, notice wrong dose was given once patient was gone
Several rather rare and odd autoimmune diseases; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of AUTOIMMUNE DISORDER (Several rather rare and odd autoimmune diseases) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AUTOIMMUNE DISORDER (Several rather rare and odd autoimmune diseases) (seriousness criterion medically significant). At the time of the report, AUTOIMMUNE DISORDER (Several rather rare and odd autoimmune diseases) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.  Company comment: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded.; Sender's Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded
Patient noted upper lip tingling at 12 minutes after dose. She subsequently noticed tingling down her left arm.  Her BP was recorded at 139/81, Po2 97%, pulse: 80, T: 98.8 Also right hand felt cold for 2 minutes. Prior to exit, tingling resolved.  Discharged at 2:32p
This spontaneous report was received from a healthcare worker refers to an unspecified patients of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored GARDASIL, (lot #, strength, dose and frequency were unknown). No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No further information was provided. This is one of several reports from the same reporter. Additional information has been requested.
improperly stored dose of proquad; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy details were not reported.       On 23-DEC-2019, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) at a dose of 0.5 milliliter, lot # s013712, expiry date 01-NOV-2020, via unknown route for prophylaxis (product storage error). The vaccine was reconstituted with well stored sterile diluent. The vaccine was exposed to a temperature of -12.2 degree Celsius at a time frame of 25 minutes. No previous temperature excursion was reported. The call was due to digital data logger. No additional information was reported.
Bumps and dots on stomach; Redness on stomach; Itchiness on both arms; Bumps on both arms; Redness on both arms; Sweating profusely; Itchiness on back; Bumps and dots on back; Redness on back; Itchiness on stomach; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Mar-2021 and was forwarded to Moderna on 22-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness on back), KERATOSIS PILARIS (Bumps and dots on back), ERYTHEMA (Redness on back), PRURITUS (Itchiness on stomach) and KERATOSIS PILARIS (Bumps and dots on stomach) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Codeine) and Blood pressure high. Concomitant products included CANDESARTAN for Blood pressure high.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced PRURITUS (Itchiness on back), KERATOSIS PILARIS (Bumps and dots on back), ERYTHEMA (Redness on back) and PRURITUS (Itchiness on stomach). On an unknown date, the patient experienced KERATOSIS PILARIS (Bumps and dots on stomach), ERYTHEMA (Redness on stomach), PRURITUS (Itchiness on both arms), KERATOSIS PILARIS (Bumps on both arms), ERYTHEMA (Redness on both arms) and HYPERHIDROSIS (Sweating profusely). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency and CORTISONE (topical) at an unspecified dose and frequency. At the time of the report, PRURITUS (Itchiness on back), KERATOSIS PILARIS (Bumps and dots on back), ERYTHEMA (Redness on back), PRURITUS (Itchiness on stomach), KERATOSIS PILARIS (Bumps and dots on stomach), ERYTHEMA (Redness on stomach), PRURITUS (Itchiness on both arms), KERATOSIS PILARIS (Bumps on both arms), ERYTHEMA (Redness on both arms) and HYPERHIDROSIS (Sweating profusely) outcome was unknown. Not Provided          Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: ADR form
FELT LIGHTHEADED NAUSEA. THEN ATE CRAKERS AND JUICE AND STATES SHE VOMITED APPROX 2 MINUTES AFTER EATING. VITAL SIGNS WERE CHECKED AND STABLE. BP 131/89, P90, TEMP 97.9.
This spontaneous report was received from a physician via a company representative refers to a 21 year old female patient. Approximately on an unknown date in April 2009 (reported as 4 years ago) the patient was vaccinated with dose 1, GARDASIL (lot # and expiration date not reported), intramuscularly (reported as standard route). The patient's father reported that since the beginning of college late in August 2012 his daughter has begun displaying symptoms of aluminum toxicity. Symptoms included increases stress and tiredness. The physician reported that the patient had written a ten-page report regarding the issue basing his information on two websites. The father claimed that his daughter had an allergy to cats which left her with a compromised immune system leading to the aluminum toxicity. He was requesting further tests to confirm his belief. The physician noted that no adverse symptoms had been reported until after patient began college. The outcome of the reported events were unknown. Patient sought an unspecified medical attention. Causality was not reported. Additional information has been requested.
Information has been received from a consumer concerning her 15 year old son with allergy to eggs and oatmeal and patient's mother with SJOREN'S syndrome who on 26-MAR-2008 was vaccinated with the first dose of measles virus vaccine. There was no concomitant medication. On 02-APR-2008, "seven days after receiving his first dose", the patient developed a hot, red face, limping, gait, decreased urination, loose stools, increased drooling. The patient also exhibited "unusual behavior" such as staring and rocking as well as hitting his arms and legs. The patient was examined by his unspecified physician but no treatment was recommended. The symptoms resolved without treatment in one month.  The mother also reported that subsequently the patient exhibited similar symptoms seven days after receiving is first dose of VARIVAX (Merck) (WAES # 0903USA00002).  Follow-up information received from the patient's mother which reported that in approximately March 2009, "recently", her son was diagnosed with celiac disease and this might be the reason he experienced the adverse event.  The mother reported in follow up that her other son had a similar reaction when he got HIB (OMPC) and PREVENAR concomitantly (WAES# 0903USA02851).  No further information is available.
Narrative:  Patient had 1st covid moderna vaccine on 2/26/21. He had no adverse effects. He had 2nd vaccine dose on 3/26/21. He presented to podiatry appointment on 4/5 complaining of right leg and calf swelling much greater than his left and is painful for him. Podiatry ordered US which showed R Leg DVT. Patient was taken to the ER and started on rivaroxaban starter pack. Thrombophilia panel was drawn and was negative. History of complicated orthopedic trauma to his right lower extremity. Also course is complicated by multiple surgical procedures of the right knee including total knee arthroplasty and osteotomy. Patient reports being on Coumadin in the past for DVT prophylaxis, but is vehemently denying history of deep vein thrombosis. No history of COVID infection.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 31-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 24-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment product information was not provided. The vaccines were stored in freezer and they took out one to two vials and placed in fridge each day as needed.
Pt recv vax on unknown day; 2 - 3 wk post vax pt exp rash on chest & back (red bumps); tx=iodine applications
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose01/10/21 2nd dose02/07/21 Diagnosed covid positive:09/16/21 Symptom onset:09/15/21 Exposure: Symptoms:fatigue,sore throat,Runny nose,HA
This spontaneous report was received from a other health professional regarding unknown number of patients of unknown demographics. No concurrent condition and historical medication was reported. On an unknown date, unknown number of patients were vaccinated with improperly stored (Merck) VARIVAX lot number K018964, expiration date- 15-OCT-2016 and lot # K011800, expiration date- 12-AUG-2016. No adverse event was reported. No product quality complaint was involved. No concomitant medication was reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information is not expected because reporter did not want to get contacted.
Approximately nine minutes after pnemovax, complained of shortness of breath, face flushed, sweaty. BP 140/88, P 104, R 20. Oxygen via face mask, redned, no hives, no swelling, denied itching, pain. Reclined approximately fifteen minutes. Recovered without further complaints. History of passing out to pain(per patient).
Initial information received on 16-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 5 years old male patient who experienced nausea while he received vaccine IPV (VERO) [IPOL]. The patients past medical history, medical treatment, vaccination, concomitant medication and family history were not provided. It was also a case of an actual medication error due to overdose as medical assistant on 26-Jun-2018 gave ipol 3ml, or 6 times recommended 0.5ml dose, due to thinking it was single dose vial instead of mdv. On 26-Jun-2018, the patient received a 0.5ml dose of suspect IPV (VERO) lot number, expiry date not reported via unknown route in unknown administration site. On 26-Jun-2018, the patient developed a non-serious nausea with unknown latency following the administration of IPV (VERO). Patient was treated in emergency room. Final diagnosis was nausea and overdose. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for nausea. 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.
After 8 minutes I broke out in a cold sweat and immediately passed out for 30-45 seconds. I woke up laying on my back not knowing how I got there.
This spontaneous report has been received from a registered nurse concerning an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and pertinent medical history were not reported. On unspecified dates, the patients received an improperly stored dose of ROTATEQ with a lot # K016314 and expiration date of 05-JUN-2016, (strength, route of administration and dose were not provided). There was no concomitant therapy reported. No adverse event was reported and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient was vaccinated with 0.3 ml of the vaccine from a vial that was diluted with 2ml of 0.9% sodium chloride instead of the required 1.8ml.
Pfizer Bivalent 5 to 11 inadvertanly administered as 2nd dose in series
3 or 4 of soft stools( diarrhea), 5 soft stools; a couple of chills; got cold; goose bumps easily; This is a spontaneous report from a contactable Other Health Professional (patient). A 20-year-old female patient, not pregnant at the time of vaccination, received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1284), via an unspecified route of administration in right arm on 22Dec2020 16:00 at single dose for COVID-19 immunization. Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medication the patient received within 2 weeks of vaccination included cetirizine hydrochloride (CETRIZINE, 10 mg), 10mg, per day. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. Allergies to medications, food, or other products: No. The patient experienced 3 or 4 of soft stools( diarrhea), 5 soft stools, a couple of chills, got cold and goose bumps easily on 23Dec2020 11:00 AM with outcome of not recovered. The patient had about 3 or 4 of soft stools (diarrhea) on 23Dec2020. Had a couple of chills and sense of urgency going to the restroom and have had 5 soft stools(diarrhea) on 24Dec2020. The patient felt and got cold, chills, and goose bumps easily. AE resulted in none. No treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19. Identification of the case safety report: Serious: No. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No.
COVID positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID positive) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis (moderate to severe).   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID positive). At the time of the report, COVID-19 (COVID positive) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Concomitant medication of the patient was not reported.   Formulation of Humira (adalimumab) was reported as solution for injection in pre-filled pen.  Primary reporter did not have the lot number information of Humira (Adalimumab), because the packaging was discarded. It was unknown if the patient was enrolled in a COVID-19 vaccine trial.  Causality for Humira (adalimumab): The reporter's causality for the event of COVID positive with Humira (adalimumab) was no reasonable possibility.  No treatment information was provided by the reporter.  Company Comment: This is a spontaneous case concerning an adult female patient with no relevant medical history, who experienced the unexpected, non-serious, adverse event of special interest, COVID-19 which occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine and the co-suspect, non-company product Adalimumab (Humira). No further information on risk factors, co morbidities, clinical course and management of the events was available in the report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning an adult female patient with no relevant medical history, who experienced the unexpected, non-serious, adverse event of special interest, COVID-19 which occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine and the co-suspect, non-company product Adalimumab (Humira). No further information on risk factors, co morbidities, clinical course and management of the events was available in the report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.