chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AEs; HCP reports patient received PROQUAD and VARIVAX at same visit. / "The MMR II and PROQUAD vials have the same color metal on the vial once the flip cap is removed and look the same without the flip cap in place"; patient received PROQUAD and VARIVAX at same visit.Caller states error was human error; The MMR II and PROQUAD vials have the same color metal on the vial once the flip cap is removed and look the same without the flip cap in place; This spontaneous report has been received from a registered nurse referring to a patient of unknown age or gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were not reported.  On 06-JUL-2023, at the same vasit, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status recombinant human albumin (rHA)) (PROQUAD) subcutaneous injection, 0.5 milliliter, lot #W034213, expiration date: 24-APR-2024, administered subcutaneously (SQ) at right thigh for prophylaxis (strength was not provided); and varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #W011625, expiration date reported as 11-OCT-2024 but upon internal validation established as 06-APR-2024, administered SQ at right thigh for prophylaxis (strength and dose was not provided) (accidental overdose). The reporter stated it was a human error, but also stated the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) vials had the same color metal on the vial once the flip cap removed and looked the same without the flip cap in place (product packaging confusion, wrong product administered). No other information was provided. No additional adverse events or PQC was reported.
103 degree fever for 2 days right arm and shoulder paralysis for 1.5 weeks
This case was reported via medical records and a statement of injuries forwarded by a lawyer and described the occurrence of hearing loss in a female subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of LYMERIX (unknown). According to the statement of injuries, at an unspecified time after vaccination with LYMERIX, the subject experienced hearing loss, vertigo, flu-like symptoms, headaches, possible memory loss, possible neurological injuries, possible autoimmune disease, and decreased activities of daily life. At the time of reporting the outcome of the events was unspecified. This case was assessed as medically serious by GSK. The following information was received via medical records. The subject was noted to have left-sided Meniere's disease and underwent a myringotomy and micro-wick placement with steroid administration on an unspecified date, followed by persistent 20 percent posterosuperior tympanic membrane perforation. On 16 March 2004, she underwent a left paper patch tympanoplasty. According to a patient history record dated 02 August 2004, the subject had a "Meniere's-like syndrome" affecting the left ear, left ear tinnitus, and questionable hearing loss. On 24 June 2005, it was noted that the patient had on and off numbness involving the ulnar nerve distribution of her right hand with chronic medial pain. On 05 July 2005, electromyograph and nerve conduction studies showed mild ulnar neuropathy. Between December 2006 and February 2008 the subject was seen for ongoing right elbow and right shoulder pain, with resulting impressions of symptomatic right shoulder rotator cuff tendinosis with underlying arthralgias and right elbow medial epicondylitis with underlying arthralgias and synovitis. Treatment included LIDOCAINE and KENALOG injections and NAPROXEN. The subject was evaluated on 07 May 2008 with a new complaint of significant numbness radiating down her right upper extremity below the elbow, with sharp severe medial elbow pain and difficulty with activities of daily living. Impression was right upper extremity numbness with probable cubital tunnel syndrome and/or carpal tunnel syndrome, and planned treatment included an over the counter anti-inflammatory medication, activity modification, and diagnostic testing. These events were assessed to be incidental findings based upon medical record review.
Light headed, heart fluttering, anxiety, hyperventilating. EMS evaluated and cleared patient.
I am having severe burning in my stomach and feel my heartbeat in my stomach. I have nausea, pain, and cramping. CT scan showed problems with the pancreas showing EPI. I am very limited now on what I can eat. I still need more exams by the gastrologist which I am seeing next month.
A report has been received from a Health Professional concerning a 7 year old, Female subject, who had been receiving Nasal FLUMIST Quadrivalent (Intranasal), 0.2 Millilitres. FLUMIST Quadrivalent (Intranasal) started on 11-Mar-2016. It was reported that the patient received FLUMIST on 11-Mar-2016 that expired on 09-Mar-2016. The outcome of the event of expired dose (medication error) is unknown. The reporter's description of the event(s) was as follows: No medical or prescription history. No chronic illness. The report was considered to be non-serious.
atrial fibrillation; This spontaneous case was reported by a nurse and describes the occurrence of ATRIAL FIBRILLATION (atrial fibrillation) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included Cardiac disorder NOS (20 years ago).    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (atrial fibrillation) 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.   No Treatment information were reported.  No concomitant medication was reported.  Patent did not have COVID-19 and she has no history of myocarditis or pericarditis.  Treatment for atrial fibrillation, cardiac ablation was placement of pacemaker.  Company comment: This case concerns a female patient of an unknown age, with previous relevant medical history of cardiac disorder, who experienced the unexpected event of atrial fibrillation. The event occurred on an unknown number of days after the first dose of mRNA-1273. The rechallenge was unknown since it is unknown the outcome of the event. The medical history cardiac disorder remains a confounder. The Benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-026566 (Patient Link).; Sender's Comments: This case concerns a female patient of an unknown age, with previous relevant medical history of cardiac disorder, who experienced the unexpected event of atrial fibrillation. The event occurred on an unknown number of days after the first dose of mRNA-1273. The rechallenge was unknown since it is unknown the outcome of the event. The medical history cardiac disorder remains a confounder. The Benefit-risk relationship of mRNA-1273 is not affected by this report.
The PCP had a cousin that died from the covid vaccine; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The reporter's new PCP recommended that she not take the COVID vaccine. The PCP had a cousin that died from the COVID vaccine. They had done all of the autopsy and everything and he had just died, so the doctor had kind of advised caller not to do it. The patient died on an unspecified date. The cause of death was not reported.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: died from the covid vaccine
Red circular ring around the injection site; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (Red circular ring around the injection site) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red circular ring around the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Red circular ring around the injection site) 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.   no concomitants were provided no treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: An additional document was received on 19 APR 2021 with email address updated
Left Eye is still twitching on the bottom lens Constantly  all day and night long.; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) in the left arm on 09Apr2021 at 11:00 (at the age of 51-year-old) as a single dose for COVID-19 immunisation and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) in the right arm on 03May2021 at 10:00 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any medication within two weeks of vaccination. No past drug therapy was provided. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 10Apr2021 at 16:00 the patient experienced left eye is still twitching on the bottom lens constantly  all day and night long. On 12Apr2021, the patient underwent  Rapid Antigen test and the result was negative. The clinical outcome of the event eyelid twitching was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Rt arm from shoulder - elbow, red, swollen, hot to touch.  C/o pain and itching to whole area. Started small area day after vaccination and gradually grown in size.
nurse reports that when she administered pentacel to a patient, she did not reconstituted the liquid dtap-ipv portion with the powder hib portion; states that she only administered the liquid dtap-ipv portion with no adverse event; Initial information received on 16-Aug-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 6 month old male patient and nurse reports that when administered diphtheria/tetanus/5 Hybrid AC Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] to a patient, she did not reconstituted the liquid dtap-ipv portion with the powder hib portion; states that only administered the liquid dtap-ipv portion with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Rotavirus Vaccine And Pneumococcal Vaccine Conj (Pneumococcal Conjugate Vaccine) for Prophylactic vaccination.  On 15-Aug-2023, the patient received a dose 3 at a dose of 0.5 ml of suspect DIPHTHERIAdiphtheria/tetanus/5 Hybrid AC Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (strength: standard, frequency: once, expiry date: 02-Apr-2024, lot UJ859AA) via intramuscular route in the left thigh for Prophylactic vaccination (immunization) and nurse did not reconstituted the liquid dtap-ipv portion with the powder hib portion; states that only administered the liquid dtap-ipv portion with no adverse event (Single component of a two-component product administered) (latency: same day)  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the events.   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 the guidelines. 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.
Vomit, Diarrhea for 12 hours Fever 100 for approximately 15 hours  Extreme Fatigue 48 hours
After about 5 minutes she got really nauseous and felt light headed.  Had her sit with her head down and try to relax. Took her blood pressure, it was low, she was still alert and oriented. She sat for another 10 and started feeling better, took blood pressure again it had come up.  She called her family to pick her up. After about 40 minutes her bp was  normal and she was feeling better she left with her mother.
This spontaneous report was received from a administrator and refers to a currently 21 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. In October 2013, the patient was vaccinated with the first dose of GARDASIL (dose, route, lot number and expiration date were not reported) and on 10-APR-2014, the patient was vaccinated with the second dose of GARDASIL (dose, route, lot number and expiration date were not reported), both for prophylaxis. At the time of reporting, the patient had not received the third dose of GARDASIL (schedule of drug administration). Additional information has been requested.
Patient had upper body nerve pains; followed by generalized rash over her entire body; followed by blisters. Was treated in office with PO steroids, IM steroids, PO Pepcid and PO Benadryl. Once blisters developed after treatment in office, patient was referred to the ER.
Morbilliform rash - generalized - Rx calamine - BENADRYL.
Left index finger from 2nd joint to too is numb and I frequently have tingling in my left index finger and left thumb. This started right after I had the vaccine and is ongoing.
1 - 10 days sysmptoms (Pain in the next, feeling tired, unwanted fast heart beat, pain in right arm where the vaccine inject. 11-14 difficulty in breating, easily getting tire, pain in chest (any area).
30MAR96 dx hives-DPH po as directed; 3APR96 rash persists-not itchy
This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 84-year-old male patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). On 30th January 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 1st February 2018, 2 days after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. The reporter considered the injection site pain to be probably related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX on the left arm. On 15th March 2018, the patient returned to the pharmacy complaining that he had a persistent dull pain at the injection site, which began approximately 2 days after he receiving the vaccine. The reporter reported that the patient did not have concomitant vaccines and known significant medical history.
Nausea, vomiting, headache, fatigue, achey body, fever.
Swelling at injection site, pain at injection site, swollen lymph nodes and pain of left mandible.  Next day body aches, nausea, and fevers.  Swelling at injection site grew larger and regressed by third day.
COVID 19; COVID 19; Dose: 5; Moderna vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EL9264), in left arm, on 17Feb2021 as dose 2, single (Lot number: EL9266), in left arm, on 30Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 19Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 65 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Sep2022 as dose 5 (booster), single (Lot number: AS7144B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. The patient took concomitant medications. Past drug history included: Macrodantin, reaction(s): "Known allergies: Macrodantin", notes: Known allergies: Macrodantin. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09Sep2022, outcome "unknown", described as "Dose: 5; Moderna vaccine"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 29Nov2022 to 03Dec2022,  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Had large, hard, 2 inch red welt for a week at site of injection. Headache. Woke in middle of night with teeth chattering coldness that could only be stopped in a hot bath. Aching arm .
This spontaneous report as received from a physician refers to two patients of unknown demographics. The patients' pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patients were vaccinated with GARDASIL (strength, dose, frequency, therapy route, indication and lot number were not reported) (unspecified if the product was GARDASIL or GARDASIL 9). Concomitant medications were not reported. The physician reported that, an unspecified patient mentioned that two patients died after receiving the vaccine. The cause of the death was not reported. The outcome of event was fatal. Causality assessment was not provided. No product quality complaint was reported. Upon internal review, death was considered as medically significant. Additional information has been requested.
Pt received first Moderna COVID vaccine on 1/14/22 and never received the second.  When in the office for a WCC on 8/19/22, we administered Pfizer COVID vaccine for what was the second vaccine in the primary series.
did not feel too good either; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (did not feel too good either) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced FEELING ABNORMAL (did not feel too good either). At the time of the report, FEELING ABNORMAL (did not feel too good either) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant drugs were not reported. Treatment medications were not provided.   This case was linked to MOD-2022-456197 (Patient Link).
EXPIRED VACCINE USED; This spontaneous report received from a health care professional concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A expiry: 21-SEP-2021) dose was not reported, administered on 04-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-OCT-2021, the patient experienced expired vaccine used. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine used was not reported. This report was non-serious. This case, from the same reporter is linked to 20211006668, 20211006798, 20211009653 and 20211009632.
sick with pancreatitis; sick with pancreatitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2), administration date Sep2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination or not. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine or not. The following information was reported: PANCREATITIS (medically significant), MALAISE (non-serious), outcome "not recovered" and all described as "sick with pancreatitis". The event "sick with pancreatitis" was evaluated at the physician office visit. The physician told the patient that this were one of the side effects of the vaccine. Therapeutic measures were taken as a result of pancreatitis and malaise which included unspecified medications. It was unknown if the patient was tested for COVID-19 since the vaccination or not.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Redness where shot was given; This case was reported by a consumer via media and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 8th September 2021, the patient received Shingles vaccine. In September 2021, less than a week after receiving Shingles vaccine, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself or himself. The age at vaccination was not reported. The patient received shingles shot on Wednesday and now there was redness where shot was given. The patient enquired if he or she should worry about this. No contact details were reported hence follow-up not possible.
pt recvd vax 930AM 20JAN93 & mom reports pt has been crying & screaming inconsolably since that time ( 6 hrs @ present); no fever or local reaction; mom consulted Pediatrician @ this point who requested seeing pt @ ER;
Patient got her second Shingrix shot  10 days after her first one.  She totally forgot that she got it.  She was having little fever last night and some body aches.  She is doing good today.
Initial misuse report received from a healthcare professional (pharmacist) on 06 February 2014. A patient whose demographics were not reported had received only the DTAP-IPV portion of PENTACEL. No adverse event was reported. List of documents held by sender: none.