chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report has been received from a Health Professional concerning a 2 year old, female subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on 09-DEC-2014. The patient was administered with expired FLUMIST Quadrivalent which started on 09-DEC-2014. The outcome of the event of inadvertently administered expired FLUMIST Quadrivalent to a patient is unknown. The report was considered to be non-serious.
Oral blisters; Autoimmune condition; mucous membrane pemphigoid; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 26May2021 13:00 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history was reported as none. Patient was not pregnant, and has no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included cephalexin (CEFALEXIN) received within 2 weeks of vaccination. The patient experienced oral blisters, autoimmune condition and mucous membrane pemphigoid, all on 09Jun2021 12:00. It was however reported that patient was diagnosed with mucous membrane pemphigoid by biopsy in Aug2021. The events were reported as serious, disability. Events resulted in Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has been tested for COVID-19 with unknown results. The patient underwent lab tests and procedures which included biopsy: diagnosed with mucous membrane pemphigoid in Aug2021, and sars-cov-2 test (nasal swab): unknown results in 2021. Treatment for the events included steroids. Patient received the second dose of BNT162b2 on an unspecified date in 2021. The outcome of the events was not recovered.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
covid-19; covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 05Apr2021 at 12:00 as dose 2, single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 30Oct2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07Jul2022, outcome "unknown" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jul2022) Negative; (15Jul2022) Negative; (16Jul2022) Negative; (17Jul2022) Positive; (07Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient has no known allergies and other medical history. The patient had not received any other medication in 2 weeks. The patient reported Paxlovid rebound. Patient's symptoms started on 07Jul2022. She tested positive and started Paxlovid on 08Jul2022. It was taken exactly as prescribed with course completed on 13Jul2022. Symptoms abated by 13Jul2022 and tested negative with Binax on 14Jul2022, 15Jul2022 and 16Jul2022. Symptoms then returned on evening of 16Jul2022. On 17Jul2022, the patient tested positive for COVID-19 using Binax. The patient also had Paxlovid mouth (metallic taste) every time after she took each dose and lasted approximately 3 hours after each dose.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
About 8 hours after injection, began to have flu like symptoms and they continually worsened into severe symptoms; body aches, fever, cough, tiredness.  Took Tylenol for these symtoms.
exposed to daughter on 17Feb2021 who tested positive for covid on 18Feb2021; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 75 (age unit unknown) old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via unknown route on 04Feb2021 at single dose for covid-19 immunisation. The patient is scheduled for second Pfizer COVID vaccine on 25Feb2021. Patient was exposed to daughter on 17Feb2021 who tested positive for COVID on 18Feb2021. Reportedly, patient had no symptoms of COVID but was asking if it's okay to go ahead with her appointment for the second Pfizer COVID vaccine on 25Feb2021. The outcome of the event was unknown.   Information on lot number/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Allergic reaction to tape around vaccination site with erythemia and itching eight days after vaccination.  Opsite removed and instructed to cover only with 2x2 gauze and use paper tape.  Also suggested a holiday from dressing and to wear long sleeves.
Left Arm started with pronounced soreness, pain & bruising, which did not occur with 1st Covid shot or any other previous & numerous vaccinations in the past.  Over the last 36 hours, it has developed into a more pronounced red rash that has extended from the side of the arm around to the rear of the arm with a burning sensation. It not only itches, but burns and the appearance of the rash continues to spread.
Severe headache, fever of 100.7, nausea, vomiting, muscle aches, fatigue
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 11-APR-2016 the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB, (dosing regimen unspecified) lot # K026666, expiry date-22-OCT-2016. No adverse effects reported. No laboratory tests were reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Came home after the vax...all was well until a wave of overwhelming weariness came over me...i sat on the couch to close my eyes and slept 5 hours.  Moved into bed around 8pm and slept til 4am on the 29th...was up for a matter of hours then slept for maybe 15 hours total...morning of the 30th i am feeling much better.  This was not sleep...more like passing out.
January 22nd I noted start of headache and mild fatigue.  January 23rd early am (~2am) awoke with chills, dry heaves, intense headache, significant nausea.  January 24th ongoing intense headache and fatigue- called into work and took day off.  By afternoon headache was improving but still present.  January 25th went to work, noted mild headache and scratchy throat, mild fatigue.  By that evening increased headache, fatigue.  January 26th awoke with extreme headache, fatigue, sinus congestion.  Complete Binax home Covid Test and immediately positive.  Went into quarentine with ongoing headache, fatigue, sinus congestion, had intermittent diarrhea, stomach ache as well. Cough also started during this time and increased throughout that duration during daytime primarily. Headache was very intense as well as fatigue through  January 31st.  Resumed half days of work on Feb 1st with milder headache, fatigue, lack of appetite.  Headache did not resolve until nearly 3 weeks.  On February 4th I did go to urgent care as sinus congestion had improved but then resumed with increased headache, cough.  Chest xray was completed and negative for pneumonia.  Suspected start of sinus infection as well as airway irritation- prescribed antibiotic for sinus infection, albuteral inhaler as needed for cough.   Sinus symptoms improved within 3-4 days (took full dose course of treatment prescribed) and cough did improve with inhaler.  My energy level has not yet returned to what it was prior- I go to bed earlier than usual, my muscles get sore more quickly with activity as do my joints.  I work as a physical therapist and am used to being very active in general, as well as at work in outpatient orthopedic care setting.  Most days I am still quite tired after work/activity.   2-24-22  I noted same type of intense headache again and fatigue.  If I try to increase my activity, then the headache and fatigue resume.
Patient states that his entire life has been turned upside down. Unable to use arm or do anything with it. Now says a cyst in arm after MRI.
The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Agency recommends being revaccinated at their earliest convenience.
get the flu; sore throat; Runny nose; Runny eyes; Fever was 102; Initial information received on 21-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves an elderly female patient who get the flu (Influenza) with symptoms sore throat (oropharyngeal pain), fever was 102 (pyrexia), runny nose and eyes (rhinorrhea) (lacrimation increased) while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past vaccination included flu shot every year and from the last 15 years (has not gotten a cold or flu). The patient's past medical history, medical treatment(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (injection) (lot number and expiry date not reported) via unknown route in the arm.  On an unknown date the patient developed a non-serious flu (Influenza), sore throat (oropharyngeal pain), fever was 102 (pyrexia), runny nose (rhinorrhea) and runny eyes (lacrimation increased) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. It was reported that the patient got the Fluzone HD 2 weeks ago and started with a sore throat initially and she thought it was due to the vinegar and oil she eats that caused the sore throat. This continued for 4 days and then woke up on Saturday morning a week ago with fever, runny nose and eyes. Her fever was 102 and next day she did not have fever came back but it has not been over 100.  Relevant laboratory test results included: On an unknown date the body temperature showed that the fever was 102.  Final diagnosis was Influenza.   It was not reported if the patient received a corrective treatment.  The outcome for all the events were not reported.
This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 75-year-old female patient who received SHINGRIX (batch number 9XC39, expiry date 30th January 2020). Concomitant products included BREO, PRILOSEC, trazodone, ARMOUR THYROID, azithromycin, ethambutol, Metoprolol, Rifampin, rosuvastatin, TRAVATAN Z and triamcinolone. On 13th December 2017, the patient received the 1st dose of SHINGRIX. In December 2017, less than a week after receiving SHINGRIX, the patient experienced pain in arm, swelling arm and erythema of extremities. On an unknown date, the outcome of the pain in arm, swelling arm and erythema of extremities were unknown. The reporter considered the pain in arm, swelling arm and erythema of extremities to be almost certainly related to SHINGRIX. Additional details were provided as follows: This case was not previously reported to anyone. Concomitant products also included CLODERM and hormone replacement therapy. The patient received SHINGRIX on the left arm and experienced pain in her left arm, redness on her left arm, and swelling on her left arm. This case has been linked with US2017GSK200906, reported by same reporter.
My blood pressure was 140/80; feel lightheaded; my vision seemed slightly impaired and started to tunnel inward; my color had gone grey; felt pressure in the backs of my eyes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 54-year-old female patient received BNT162b2 (BNT162B2), administered in arm left, administration date 08Apr2021 12:00 (Lot number: ER8735) at the age of 54 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergies" (unspecified if ongoing), notes: Allergies to cats; "Allergies: sensitivity to medication" (unspecified if ongoing), notes: sensitivity to medication; "Allergies: fire ant bites" (unspecified if ongoing), notes: Allergies to bites; "Allergies: Latex" (unspecified if ongoing), notes: Allergies to latex. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, lot number=EP6955, administration time=01:30 PM, Left arm), administration date: 17Mar2021, when the patient was 54 years old, for Covid-19 Immunization, reaction(s): "No reaction on previous exposure to vaccine". The following information was reported: BLOOD PRESSURE ABNORMAL (non-serious) with onset 08Apr2021 12:15, outcome "recovered", described as "My blood pressure was 140/80"; DIZZINESS (non-serious) with onset 08Apr2021 12:15, outcome "recovered", described as "feel lightheaded"; VISUAL IMPAIRMENT (non-serious) with onset 08Apr2021 12:15, outcome "recovered", described as "my vision seemed slightly impaired and started to tunnel inward"; EYE COLOUR CHANGE (non-serious) with onset 08Apr2021 12:15, outcome "recovered", described as "my color had gone grey"; OCULAR DISCOMFORT (non-serious) with onset 08Apr2021 12:15, outcome "recovered", described as "felt pressure in the backs of my eyes". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of blood pressure abnormal, dizziness, visual impairment, eye colour change, ocular discomfort.  Additional information: Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive other medications within 2 weeks of vaccination. Patient was not diagnosed with COVID-19 prior to vaccination.  No follow-up attempts are possible. No further information is expected.
The patient presented to the clinic for his 2nd Hepatitis A vaccine for school entry. After I administered the vaccine the mother, patient and other child proceeded to the check out window to receive updated shot record. As they were waiting, the mother yelled that something was wrong and it was paged overhead for the nurses to come to the waiting room. The mother reported that the child loss consciousness, had seizure activity and fell to the floor. Nurses and myself, as well as, ANP went to the front, one of the nurse was the first to the front. We brought the child back into a patient room where ANP assessed him. The child was also given water, juice and a small snack as the mother reported the he had not eaten since breakfast. The patient stayed in the clinic an additional 20 minutes and after having ANP assess him a 2nd time the mother and patient left the clinic.
blindness left eye; exacerbation of stromal keratitis; fever; cold sores; throat swollen; This serious case was reported by a consumer via call center representative and described the occurrence of blind left eye in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included keratitis (Stromal Keratitis).   On 17-OCT-2023, the patient received the 2nd dose of Shingrix. On 17-OCT-2023, less than a day after receiving Shingrix, the patient experienced fever (Verbatim: fever), cold sores (Verbatim: cold sores) and throat swelling (Verbatim: throat swollen). On 18-OCT-2023, the patient experienced blind left eye (Verbatim: blindness left eye) (serious criteria GSK medically significant) and condition aggravated (Verbatim: exacerbation of stromal keratitis). The outcome of the blind left eye, fever, cold sores, throat swelling and condition aggravated were unknown.   It was unknown if the reporter considered the blind left eye, fever, cold sores, throat swelling and condition aggravated to be related to Shingrix.     It was unknown if the company considered the blind left eye, fever, cold sores, throat swelling and condition aggravated to be related to Shingrix.
Myocarditis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 16-year-old male patient received BNT162B2 (BNT162B2), administered in arm right, administration date 13Dec2021 17:00 (Lot number: FJ1620, Expiration Date: Feb2022) at the age of 16 years as dose 3 (booster), single for COVID-19 immunization. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162B2 (dose 1, single; lot number: EW0186; site: left upper arm; time: 09:00), administration date: 14May2021, when the patient was 15 years old, for COVID-19 immunization; BNT162B2 (dose 2, single; lot number: EW0191; site: maybe right upper arm; time: 09:00), administration date: 03Jun2021, when the patient was 15 years old, for COVID-19 immunization. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The following information was reported: MYOCARDITIS (hospitalization, medically significant) with onset 16Dec2021, outcome "unknown", described as "Myocarditis". The patient was hospitalized for myocarditis (start date: 16Dec2021, discharge date: 18Dec2021, hospitalization duration: 2 day(s)). The patient underwent the following laboratory tests and procedures: echocardiogram: myocarditis; electrocardiogram: myocarditis; troponin: myocarditis. Clinical course: The patient had a lot of tests during hospitalization. All of the tests showed myocarditis. The tests included troponin, EKG, and echoes.  Follow-up attempts are completed. No further information is expected.
Congestion, cough, fatigue, body aches, 1 night it felt like I was breathing really fast. I was pretty sick for about 2 weeks but getting better. I took Mucinex, Robitussin, soup, tea to treat myself but it wasn't getting better, and I went to get the COVID-19 test and the nurse sent me to the hospital to get a complete checkup. At the hospital they said I still had a sinus infection and gave me Augmentin antibiotic, Mucinex and Flonase. I'm improving but still with a little cough and nasal congestion.
On 12/12/2022 I did not feel well I left work and tested positive the same day for COVID-19, on 12/14/2022 I had a miscarriage.
This spontaneous report was received from the nurse regarding a patient of unknown age. Past medical history, drug reactions/allergies and concomitant medications were not reported. On 27-JUL-2016, the patient received GARDASIL for prophylaxis. On 12-MAR-2018, the patient received GARDASIL 9 lot# N020138 with expiry date of 14-FEB-2020 for prophylaxis. No product quality complaint was involved.
Weakness, Fall, Rhabdomyolysis Narrative: Patient presented following a fall at home within 24 hours of the second COVID vaccine. Pt reported chills, weakness leading to fall, subsequently developed rhabdomyolysis requiring hospitalization due to weakness/prolonged period down after fall.
(R) deltoid reddened 4 1/2" x 5", blanched dime size at injection site, warm to touch, cold compresses 3-5-08 and 3-6-08 by parents, Tylenol given by parents to be seen after assessment at health department by pediatrician.
Shingles rash developed around right under arm about three days after soreness and burning began on 6/6. Rash appeared on 6/9 and I received diagnosis as Shingles and given valacyclovir on 6/11.  Finished course of medicine (7 days) and Rash is still healing as of  6/25
Lump and redness around injection site approximatekyl 1.2 inches in diameter. Muscle soreness and stiffness.
little waves of shock up back, neck, bones, and down sides; foot and toes felt numb and tingly; foot and toes felt numb and tingly; little pains rotating around body; leg felt heavier; A spontaneous report was received from a consumer concerning a 54-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events leg felt heavier, foot and toes felt numb and tingly, little pains rotating around body, little waves of shock up back, neck, bones, and down sides.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 17 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 023M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  The patient reported on 23-Mar-2021 that she got her first shot on 17Mar2021 in her left arm. The minute they gave it to her, her leg that has edema felt heavier and her foot and toes felt numb and tingly. It didn't wear off until she walked around for a couple of hours. At night, she started to experience little pains rotating around her body. It felt like little waves of shock going up her back, neck, bones, and down her sides. She described that pain as strong originally and then it tapered down. The patient did suffer from photophobia and she had experienced that from the different medications that she was on.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), leg felt heavier, foot and toes felt numb and tingly, little pains rotating around body, little waves of shock up back, neck, bones, and down sides was unknown.; Reporter's Comments: Based on the current available information which includes a strong temporal association between the use of the product and the start date of the reported event, and excluding any other etiology, a causal relationship with the event cannot be excluded.
Case number PHEH2014US017616 is an initial spontaneous report received from a nurse on 28 Aug 2014. This report refers to a 16 year old female patient. Past medical history and concomitant medications was not reported. She received only Men A lyophilized conjugate component of MENVEO (batch number: A13015), intramuscularly reconstituted with a sterile diluent instead of MenCYW-135 liquid component on 27 Aug 2014. No adverse reaction was reported following this administration error.
A report was received from a health care professional on 22Nov02 concerning a group of vaccinees less than 4 years old of unk demography who inadvertently received Fluvirin from approx 07Nov02 onwards. From 07Nov02 Fluvirin was administered to vaccinees less than 4 years old. There were no reported adverse events. There was insufficient information to determine the reporters causality assessment. Update 1 10Dec02: A follow up report was received by a health professional indicating that a 24 month old male vaccinee was inadvertently administered Fluvirin IM on 23Nov02. Cross reference with: PJP200200848, PJP200200849,PJP200200850,PJP200200805,PJP200200852, PJP200200853,PJP200200854, PJP200200855, PJP200200856, PJP200200857, PJP200200858, PJP200200859,PJP200200860, PJP200200861,PJP200200862, PJP200200863,PJP200200864, PJP200200865,PJP200200866,PJP200200867,PJP200200868,PJP200200869, PJP200200870, PJP200200871,PJP200200872,PJP200200873,PJP200200874,PJP200200875,PJP200200876,PJP200200877.