chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pharmacist stated a flu shot (Fluzone HD) may have been mis-administered outside of the target area/ No AE; Initial information received on 13-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 72 years old male patient who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ232AA, expiry date- 10-04-2020 via unknown route in the arm (bicep) on an unknown date, may have been mis-administered outside of the target area.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to vaccine administered at inappropriate site.  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.
Extreme lethargy, stomach pain, nausea, vomiting, sever headache, memory fog or forgetfulness, fever; Extreme lethargy, stomach pain, nausea, vomiting, sever headache, memory fog or forgetfulness, fever; Extreme lethargy, stomach pain, nausea, vomiting, sever headache, memory fog or forgetfulness, fever; Extreme lethargy, stomach pain, nausea, vomiting, sever headache, memory fog or forgetfulness, fever; Extreme lethargy, stomach pain, nausea, vomiting, sever headache, memory fog or forgetfulness, fever; Extreme lethargy, stomach pain, nausea, vomiting, sever headache, memory fog or forgetfulness, fever; Extreme lethargy, stomach pain, nausea, vomiting, sever headache, memory fog or forgetfulness, fever; This spontaneous report was received from a consumer and referred to a 11-year-old white male patient. There was no information about the patient's concurrent conditions, allergies, drug reactions or medical history provided. Concomitant therapies included amphetamine aspartate (+) amphetamine sulfate (+) dextroamphetamine saccharate (+) dextroamphetamine sulfate (ADDERALL XR).  On 21-OCT-2019, at 9:30, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) needle and syringe (not further specified), in the right arm  for prophylaxis (exact dose, lot #, expiration date, route of administration were not reported).  On 21-OCT-2019 at 20:00, the patient experienced extreme lethargy, stomach pain, nausea, vomiting, sever headache, memory fog or forgetfulness, fever. This had happened several times in two days(comes and goes). No labs or tests had been performed yet. The outcome of the events was reported as not recovered/not resolved.  The causality assessment between the events and suspect therapy was not provided.  Follow-up information has been received from an unspecified person from the physician's office on 09-NOV-2020. The reporter stated that the office received a "VAERS form" from Merck but that she could not fill it out without the patient's name and date of birth. The reporter provided MARRS# 2010USA009715 and the case was reviewed. The patient's name and date of birth were anonymized in this case and could not be provided to assist with follow up. The reporter was unable to provide any follow up information and was thanked for her time. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
got a terrible rash; pain even a month later I still have pain; This case was reported by a consumer and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of rash (1st dose received on an unknown date and experienced terrible rash and pain, refer case US2021AMR175232).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than 2 months after receiving Shingles vaccine, the patient experienced rash and pain. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the rash was unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the rash and pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient reported that, he/she had the shots of Shingles vaccine and still got a terrible rash and pain even a month later the patient still had pain.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR175232:Same reporter
Shortness of breath Severe chest pain Strong heart beat Fever Headache Severe stomach pain Unable to sleep
Student had gotten a flu vaccine on 10/21/20. He came to the campus flu clinic on 1/26/21 and received another flu vaccine, his first dose being unbeknownst to the flu clinic staff.
s/p vaccine c/o shortness of breath, "clammy", lightheaded, near syncopol, pale
after vaccination, I sat there for 15 minutes and started to drive home, stopped to get food, driving down the street I stopped somewhere and ended up sitting there for 6-8 hours according to the restaurant manager. I went to the hospital they said that I had a weird heart attack and I was dehydrated.
This spontaneous report as received from a registered nurse refers to an 4 year old patient of unknown gender who, on an unspecified date of 2014, was vaccinated with a dose of PROQUAD (lot#: J014238, expiration date: 07-MAY-2015) which on 20-FEB-2014, 25-MAR-2014 and 26-MAR-2014 were exposed to unspecified temperature excursions not exceeding 11F and for no more than 2 hours at a time. The vaccines were supported by Merck's stability data. The reporter stated that she does not believe that any patients have experienced any adverse effects. This is one of several reports (MARRS# 1403USA013236, 1404USA005557, 1404USA005558, 1404USA005560, 1404USA005561, 1404USA005562 and 1404USA005563) from the same source. Additional information has been requested.
Seizure like movements followed by fatigue. No treatment as resolved spontaneously. Parents did not report until 3 months later.
5 hours after influenza vaccine, developed dry, hacky cough. Over the next hours, bilateral eye swelling with whitish, yellow drainage, erythemia and tenderness of chest wall and nipples, chills, swelling of tongue and gums. Felt like tongue was "on fire". No SOB or wheezing. Took one Singulair tab. Sx mostly subsided over 24 hours.
Headache, body aches, fatigue, sore arm, redness and hot to touch on injection site
Patient came into pharmacy today complaining of sore left arm ever since receiving Shingrix vaccine from his doctor. He stated his arm has been extremely sore ever since. He's taken aleve to help which takes away some of the pain. Nothing really seems to make it worse or better. He described it as being an achy, bothersome pain that doesn't go away. He will be seeing his doctor during the week and will follow up at that time.
I exp low grade fever, very exhausted, weak, lethargic for about 5 days. I was hospitalized on April 10, 2021 for 4 days.
exacerbation of joint pain; arthritis; mental health issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2 NOS), 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: ARTHRALGIA (non-serious), outcome "unknown", described as "exacerbation of joint pain"; ARTHRITIS (non-serious), outcome "unknown"; MENTAL DISORDER (non-serious), outcome "unknown", described as "mental health issues".  Additional information: She knows a woman who has had an exacerbation of joint pain who had a medical condition like arthritis and also had mental health issues, and they don't know if these issues are from taking the Pfizer Covid vaccine or because she had Covid. Call provides feedback that Pfizer should make a medication to treat long Covid syndrome. Caller stated that there should be TV advertisements that list all the potential side effects for the vaccines.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt recv vax 2OCT92 & 7AUG95 pt presented w/h/a, vomiting & t105;pt adm to hosp for work/up;LP neg, but BC was pos for Haemophilus B;pt discharged fr hosp on 10AUG95 prior to results of the BC being known-readmitted 36hr later sz worse
patients that received Moderna vaccines that had been stored in the refrigerator > 30 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients that received Moderna vaccines that had been stored in the refrigerator > 30 days) 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 EXPIRED PRODUCT ADMINISTERED (patients that received Moderna vaccines that had been stored in the refrigerator > 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients that received Moderna vaccines that had been stored in the refrigerator > 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was provided.
dose that was reconstituted with a sterile water diluent; pt received a dose that was reconstituted with a sterile water diluent; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 32-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA658A, expiry date 31st January 2023) for prophylaxis.   On 20th June 2022, the patient received Menveo. On 20th June 2022, unknown after receiving Menveo, the patient experienced inappropriate dose of vaccine administered and wrong solution used in drug reconstitution. On an unknown date, the outcome of the inappropriate dose of vaccine administered and wrong solution used in drug reconstitution were unknown.   Additional Information: GSK Receipt Date: 22-JUN-2022 Reporter's Comments: The patient received a dose of Menveo that was reconstituted with a sterile water diluent vs the MenCYW-135 liquid conjugate vaccine component. The Vaccine Administration Facility was the same as Primary Reporter. Outside phone number for GlaxoSmithKline Medical Information given for future reference and warm transfer provided. The reporter gave consent to follow up. Additional supportive Information: The patient received a dose of Menveo that was reconstituted with a sterile water diluent which led to inappropriate dose of vaccine administered and wrong solution used in drug reconstitution.
hospitalization from allergic reactions to the Covid 19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A male patient received bnt162b2 (BNT162B2) (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: HYPERSENSITIVITY (hospitalization), outcome "unknown", described as "hospitalization from allergic reactions to the Covid 19 vaccine".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Case number PHEH2014US023378 is an initial spontaneous report received from a pharmacist on 19 Nov 2014. This report refers to a 46 year old male patient. Past medical history and concomitant medications was not reported. He received only Men A lyophilized conjugate component of MENVEO (batch number: A14030), intramuscularly reconstituted with a sterile water instead of MenCYW-135 liquid component on 21 Aug 2014. No adverse reaction was reported following this administration error.
PT REPORTED AFTER RECEIVING VACCINE HE WAS A LITTLE FATIGUE & ONCE HE GOT HOME HE REPORT SEIZURE ACTIVITY. HE STATED FOR APPROXIMATELY 40 MINUTES "HE WAS JUST IN A DAZE & STARING" AND AFTERWARDS HE WAS FINE.
I started having a runny nose and unrelenting cough on Tuesday May 31, 2022. I took the Home COVID-19 Test on Wednesday June 01, 2022, the positive T line was faint. I took some Tylenol and Robitussin. On Thursday I still felt unwell and took a second home COVID-19 TEST,  the positive T line came back positive only darker this time. I called Urgent Care but they advised me to call my Primary Care as they were very busy. Before I called my Primary Care Physician I took a third home COVID-19 test, the T line came back positive and darker. I had a telemedicine with my Primary Care Physician who verified my results and advised me to go to the ER if my oxygen went into the 80's on my oximeter. I was prescribed Paxlovid and Codeine cough syrup. I picked both up late Friday afternoon.  I do feel that Friday was the worst day of my whole time being ill. But as of today, June 06. 2022, I still get winded, but I am not as achy as I was, the coughing has subsided, and I'm still a little stuffy.
Started to get irritated eyes a couple hours after vaccination.  About 5 hours after vaccination he had red, itchy eyes, burning throat, and cough.  Seen by provider and given Solumedrol injection, Benadryl and Prednisone prescription.
REBOUND COVIDS/ COVID 19 Treatment; REBOUND COVIDS/ COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 as dose 5 (booster), single (Lot number: 6yk24) at the age of 79 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 23Jan2021 as dose 1, single (Lot number: EL3247), in left arm, on 15Feb2021 as dose 2, single (Lot number: EN9581), in left arm and on 24Sep2021 as dose 3 (booster), single (Lot number: FD8448) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 13Feb2022 as dose 4 (booster), single (Lot number: 056M21A), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VERAPAMIL; ATORVASTATIN. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 10Oct2022, outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Dec2022, outcome "recovering" and all described as "REBOUND COVIDS/ COVID 19 Treatment". Therapeutic measures were not taken as a result of vaccination failure, covid-19.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 51-year-old male patient 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 PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  It was reported that there have been no power outages that would have impacted the Moderna vaccine. However, reporter reiterated that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger that caller was unable to download for the months of DEC2021, JAN2022, and FEB2022. Reporter said that they are filling out a temperature excursion assessment with the State at this time and she was calling in to report the same to Moderna. Reporter confirmed that patients have been administered doses while the temperature excursion assessment has been ongoing. It was reported that no adverse reactions were reported by any patients.
Vaccine arm swollen, woke up with hand tingling, and red palm. Red palm and tingling went away within 30 minutes. But 2-3 hours later three fingers had peeling.  Also wrinkly fingers.  Increased water and added electrolytes. Notified doctor, who instructed to elevate and ice arm, and to start benadryl. Also take benadryl before next vaccine.  Left arm may still be slightly swollen, but most swelling gone by 12 hours.  Sore arm for a couple days, intermittent headache which took tylenol for. Fatigue, still.
Approximately 7 minutes after receiving vaccine patient complained of burning, mom noted hives on chest, arms.  I notified provider and gave a dose of Benadryl.  Hives and burning resolved within 5 minutes.
COVID-19; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID-19) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Patient not had any drug allergy.  Concurrent medical conditions included Blood pressure high.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 19-May-2022 to 23-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: negative Negative on the 4th day. In June 2022, SARS-CoV-2 test: positive Positive. On an unknown date, SARS-CoV-2 test: positive Positive for antigen..     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. It was reported that the patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. It was reported that patient had mild scratchy throat congestion and tested positive for antigen. Patient started Paxlovid very early. Symptoms improved on 3 days, tested negative on 4th day. Patient finished the Paxlovid and on 4-JUN-2022 started getting same symptoms 3 days after testing negative and tested positive again.  Company comment-This spontaneous case concerns an elderly patient aged 66 years of unknown gender, with no relevant medical history reported, who experienced the unexpected non serious of Covid 19 on an unknown date after receiving the 2nd dose of mRNA-1273 vaccine in the covid 19 vaccination series. Patient reported covid symptoms, tested positive for antigen on an unknown date and was treated with Paxlovid from 19th May 2022 to 23rd May2022 for 5 days. Symptoms improved after 3 days with a negative test on 4th day. Three days later was tested positive again with recurrence of symptoms. The current pandemic situation of COVID 19 may remain as confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement.; Sender's Comments: This spontaneous case concerns an elderly patient aged 66 years of unknown gender, with no relevant medical history reported, who experienced the unexpected non serious of Covid 19 on an unknown date after receiving the 2nd dose of mRNA-1273 vaccine in the covid 19 vaccination series. Patient reported covid symptoms, tested positive for antigen on an unknown date and was treated with Paxlovid from 19th May 2022 to 23rd May2022 for 5 days. Symptoms improved after 3 days with a negative test on 4th day. Three days later was tested positive again with recurrence of symptoms. The current pandemic situation of COVID 19 may remain as confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement.
redness at vaccination site/measured 6" long by 4 " wide; itchy reaction at the injection site; the injection site that was warm to the touch; raised at injection site; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE ERYTHEMA (redness at vaccination site/measured 6" long by 4 " wide), VACCINATION SITE PRURITUS (itchy reaction at the injection site), VACCINATION SITE WARMTH (the injection site that was warm to the touch) and VACCINATION SITE SWELLING (raised at injection site) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (redness at vaccination site/measured 6" long by 4 " wide), VACCINATION SITE PRURITUS (itchy reaction at the injection site), VACCINATION SITE WARMTH (the injection site that was warm to the touch) and VACCINATION SITE SWELLING (raised at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (redness at vaccination site/measured 6" long by 4 " wide), VACCINATION SITE PRURITUS (itchy reaction at the injection site), VACCINATION SITE WARMTH (the injection site that was warm to the touch) and VACCINATION SITE SWELLING (raised at injection site) had resolved.        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.   No relevant concomitant medications were reported. No treatment information was provided.
Leg is red hard warm to touch and hurts, in right leg. Leg is swollen.