chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st dose 07Jan2021; no 2nd dose; flushing; light headed; difficulty swallowing her saliva; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of FLUSHING (flushing), DIZZINESS (light headed) and DYSPHAGIA (difficulty swallowing her saliva) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 07-Jan-2021, the patient experienced FLUSHING (flushing) (seriousness criterion medically significant), DIZZINESS (light headed) (seriousness criterion medically significant) and DYSPHAGIA (difficulty swallowing her saliva) (seriousness criterion medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (1st dose 07Jan2021; no 2nd dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form and OXYGEN on 07-Jan-2021 at a dose of 1 dosage form. On 07-Jan-2021, FLUSHING (flushing), DIZZINESS (light headed) and DYSPHAGIA (difficulty swallowing her saliva) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (1st dose 07Jan2021; no 2nd dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2021, Blood pressure systolic: 133 to188 (High) from 133 to188. On 07-Jan-2021, Heart rate: 74 to 118 (High) heart rate went up from 74 to 118.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant information was not provided by reporter.  Patient  was given Benadryl and O2 but the symptoms persisted so patient was taken to the emergency room (ER). At the ER, she was given steroids and O2.  Company Comment : This report refers to a case of Product dose omission issue with associated AEs. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: This report refers to a case of Product dose omission issue with associated AEs. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report as received from a 74 year old male patient with cholesterol regarding himself. On an unknown date in May 2009 the patient was vaccinated with ZOSTAVAX (lot number and expiry date not reported) (dosing regimen unknown) 1 time vaccine. Concomitant therapies included PLAVIX, ECOTRIN, EDARBI, metoprolol (Manufacturer unknown), LESCOL XL, ZETIA, pantoprazole (Manufacturer unknown) ZANTAC, tamsulosin hydrochloride (Manufacturer unknown) and levomefolate calcium, mecobalamin, METANX. On an unknown date in August 2013 the patient experienced shingles. The patient sought medical attention. The patient was treated with Valacyclovir (VALTREX) by his clinician. The outcome of shingles was reported as recovering. The relatedness of the events to the therapy with ZOSTAVAX was unknown. Additional information has been requested.
Patient's reaction(s) noted during COVID vaccine observation period:  pt stated she felt diaphoretic and lips felt a little tingly after 15 minutes of receiving vaccine    Actions Taken:  VS obtained 0845 HR 77, BP 129/63, T 98.1, O2 99%.  Pt states she is feeling better now.  VS at 0851: HR 93, BP 118/60, O2 97% Pt declined further medical observation. States she will take benadryl once she leaves if she feels she needs to.    Disposition: pt walked out of clinic after observation
Swelling, difficulty to breath, scratchy. Immediately patientwas taken to emergency room, epinephrine shot.; Difficulty to breath; Scratchy; This case was reported by a physician via call center representative and described the occurrence of swelling in a 29-month-old male patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) (batch number 2SM24, expiry date unknown) for prophylaxis.   Previously administered products included Fluarix (Last year,2019, this patient received Fluarix with any problem), Fluarix (received in November 2018) and Fluarix (received in December 2018).   On 10th October 2020, the patient received FluLaval Tetra 2020-2021 season. On 10th October 2020, less than a day after receiving FluLaval Tetra 2020-2021 season, the patient experienced swelling (serious criteria clinically significant/intervention required), difficulty breathing (serious criteria clinically significant/intervention required) and scratch (serious criteria clinically significant/intervention required). The patient was treated with epinephrine. On an unknown date, the outcome of the swelling, difficulty breathing and scratch were unknown.   It was unknown if the reporter considered the swelling, difficulty breathing and scratch to be related to FluLaval Tetra 2020-2021 season.  Additional case details were reported as follows: The age at vaccination was not reported. The patient avoid egg. The patient experienced swelling, difficulty to breath, scratchy. The patient immediately taken to emergency room, and epinephrine was given. This case has been link with US2020202326, US2020204781 and US2020AMR206612 reported by same reporter. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020202326:same reporter US-GLAXOSMITHKLINE-US2020204781:same reporter US-GLAXOSMITHKLINE-US2020AMR206612:same reporter, several patient case
My sister and I and our husbands we all got the vaccine and had a little sore arm after; This is a spontaneous report from a contactable consumer. The female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE,Batch/Lot number and Expiration date: unknown), via an unspecified route of administration on an unknown date as 1st dose single for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. Patient reported that her sister and patient and their husbands they all got the vaccine and had a little sore arm after. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected. ;
Expired Covid-19 vaccine was administered. So far no ADR's reported and no symptoms noted. Will re-vaccinate in other arm to ensure full dose was administered.
?covid arm? developing into cellulitis in my arm. Headache for 11 days fever of 103 for about 30 hrs  Received cephalexin 500 mg  for 10 days to treat arm.
Tingling of the arms and legs; This spontaneous case was reported by a pharmacist and describes the occurrence of PARAESTHESIA (Tingling of the arms and legs) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PARAESTHESIA (Tingling of the arms and legs). At the time of the report, PARAESTHESIA (Tingling of the arms and legs) had resolved. Not Provided      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 medication was reported.  Treatment information was not provided.
Fever the morning after the 2nd dose, muscle pains. I took analgesic and I got better.
Patient developed hives and lethargy 6 hours after receiving Prevnar and Hepatitis A
PAIN IN ARM; ELEVATED HEART RATE; FEVER; BODY ACHES; DIFFICULTY SLEEPING; This spontaneous report received from a pharmacist concerned an 18 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, non-alcoholic, and drug allergy, and other pre-existing medical conditions included patient had no significant medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-MAY-2021 14:00 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included diphenhydramine hydrochloride. On 03-MAY-2021, the subject experienced body aches. On 03-MAY-2021, the subject experienced difficulty sleeping. On 03-MAY-2021, the subject experienced fever. On 04-MAY-2021, Laboratory data included: Heart rate (NR: not provided) 105-120 bpm, 110 bpm. On 04-MAY-2021 02:00, the subject experienced elevated heart rate. On 04-MAY-2021 02:30, treatment medications included: paracetamol. On an unspecified date, the subject experienced pain in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from difficulty sleeping on MAY-2021, was recovering from body aches, had not recovered from elevated heart rate, and the outcome of fever and pain in arm was not reported. This report was non-serious.
Eyes puffy; Fast breathing; Rash on arms, legs, back, and face; This spontaneous case was reported by a consumer and describes the occurrence of PERIORBITAL SWELLING (Eyes puffy), TACHYPNOEA (Fast breathing) and RASH (Rash on arms, legs, back, and face) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced RASH (Rash on arms, legs, back, and face). On an unknown date, the patient experienced PERIORBITAL SWELLING (Eyes puffy) and TACHYPNOEA (Fast breathing). At the time of the report, PERIORBITAL SWELLING (Eyes puffy), TACHYPNOEA (Fast breathing) and RASH (Rash on arms, legs, back, and face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was unknown.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 72-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Sep2023 as dose 1, single (Lot number: HH7595) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Diltiazem for Hypertension, notes: Hypertension - under control w/ Diltiazem; Atorvastatin for Hyperlipidemia, notes: Hyperlipidemia, under control with atorvastatin. Vaccination history included: bnt162b2 (vaccine brand=Pfizer / BioNTech,, Vaccine brand unknown=False,, Vaccine administration date=07Oct2022,, Vaccine lot number=GJ6665,, Vaccine lot unknown=False,, Vaccine dose number=5,, Vaccine dose number unknown=False), administration date: 07Oct2022, when the patient was 71-year-old, for COVID-19 immunization; bnt162b2 (vaccine brand=Pfizer / BioNTech,, Vaccine brand unknown=False,, Vaccine administration date=11Apr2022,, Vaccine lot number=FK9894,, Vaccine lot unknown=False,, Vaccine dose number=4,, Vaccine dose number unknown=False), administration date: 11Apr2022, when the patient was 71-year-old, for COVID-19 immunization; bnt162b2 (vaccine brand=Pfizer / BioNTech,, Vaccine brand unknown=False,, Vaccine administration date=26Sep2021,, Vaccine administration date=26Sep2021,, Vaccine lot number=FC3181,, Vaccine lot unknown=False,, Vaccine dose number=3,, Vaccine dose number unknown=False), administration date: 26Sep2021, when the patient was 70-year-old, for COVID-19 immunization; bnt162b2 (vaccine brand=Pfizer / BioNTech,, Vaccine brand unknown=False,, Vaccine administration date=08Mar2021,, Vaccine lot number=EN6205,, Vaccine lot unknown=False,, Vaccine dose number=2,, Vaccine dose number unknown=False), administration date: 08Mar2021, when the patient was 70-year-old, for COVID-19 immunization; bnt162b2 (vaccine brand=Pfizer / BioNTech,, Vaccine brand unknown=False,, Vaccine administration date=11Feb2021,, Vaccine lot number=EM9810,, Vaccine lot unknown=False,, Vaccine dose number=1,, Vaccine dose number unknown=False), administration date: 11Feb2021, when the patient was 69-year-old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Oct2023) Negative; (23Oct2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19, which included Paxlovid from 12Oct2023 to 16Oct2023 (Lot number=192534OA).
Tired after second vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 67-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Mar2021 (Batch/Lot number: unknown) at the age of 67 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "oral surgery", start date: Mar2020, stop date: Mar2020, notes: oral surgery in Mar2020 and was not able to eat because of the surgery. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, Lot: EN6199, Expiry Date of Covid vaccine: Unknown, Site: Caller thinks right arm, first vaccine she had no problem), administration date: 08Mar2021, when the patient was 67 years old, for Covid-19 Immunization, reaction(s): "No reaction on previous exposure to vaccine".  The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Tired after second vaccine".  Additional information: Reporter was a lab technician, stated that first vaccine she had no problem, and the second vaccine, she was tired. Caller explained that she had elective oral surgery in Mar2020 and was not able to eat because of the surgery and could not keep up her nutrition without her original teeth. The patient was Tired after second vaccine, ended within 24 hours. Facility where patient received vaccine was Covid clinic, hospital. The patient not received vaccine at a Facility. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient did not require to visit Emergency Room/Physician Office. No other vaccinations administered within four weeks prior to the first administration date of the suspect vaccine. No AE(s) following prior vaccinations. The patient had no medical History (including any illness at time of vaccination). Family Medical History Relevant to AE(s) was not provided. The patient had no relevant Tests.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a Registered Nurse referring to a 8 week old patient of unknown gender. Information about patient's concurrent conditions and medical history was not reported. On 24-JUN-2015 the patient was vaccinated with a dose of improperly stored PEDVAXHIB (route not reported, lot # reported as K025004, dose 0.5 (unit not provided). Concomitant medications were not provided. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
pt recvd vax & 10 days later exp a reticular macular rash, sl elevated on thighs & abdo & lower legs, & sparingly on face, back & arms; exp also a sl fever which lasted 4 days;
Information has been received regarding a case in litigation concerning a female who on 10-NOV-1995 was vaccinated with a first dose of Recombivax HB, and a second dose on 08 DEC 1995. On 12-APR-1996 the patient was seen by a physician for complaints of pins and needles in her left foot. On 20 APR 1996 the patient was seen by a physician for complaints that "numbness in her foot had crept up her body into her arm". It was reported that in the opinion of a neurologist that the Recombivax HB had caused the patient's atypical MS. It was noted that the onset of the MS was believed to be four months post vaccination with Recombivax HB. Upon internal review multiple sclerosis was considered to be an other medically important event (OME). Additional information is not expected.
Dad called reported that pt's RA was red and swollen-warm to touch-no pain, no itching. area 10 cm x 8 cm
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 20-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mast Cell Activation Syndrome" (unspecified if ongoing); "Known allergies: spinach" (unspecified if ongoing); "Known allergies: goat cheese" (unspecified if ongoing); "Known allergies: sulfonamide derivatives/Known allergies: sulfa" (unspecified if ongoing); "Known allergies: opium alkaloids" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Oxycodone, reaction(s): "Known allergies: Yes: oxycodone"; Trimethoprim, reaction(s): "Known allergies: trimethoprim". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional Information: Patient started PAXLOVID on 21Jul2022 for Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EN6202), at the age of 67, via an unspecified route of administration, right arm, on Mar 9, 2021, at 09:15, single dose, for COVID-19 immunisation. Medical history included allergy to penicillin and bee stings. Concomitant medications included tamsulosin hydrochloride 0.4mg for unknown indication from unknown date. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Apr 10, 2021, patient experienced joint, neck, back, shoulders, hips, muscles, legs and buttocks pain; and weakness in arms and legs. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures taken as a result of the events included prednisone. The clinical outcome of joint neck, back, shoulders, hips, muscles, legs and buttocks pain; and weakness in arms and legs: ongoing at the time of this report. No follow-up attempts needed. No further information expected.
Loss of appetite, slept 24 hrs. straight after vaccines were administered. Starting vomiting the day after. And patient did not went to eat. No fever, patient came in office 3/13/14 and 3/14/14 and is doing fine.
A patient received an expired dose of Fluzone Quadrivalent /No AE; Initial information was received on 17-Sep-2020 regarding an unsolicited valid non-serious case from a consumer (Practice manager).  This case is linked to cases 2020SA256509, 2020SA256508, 2020SA256507, 2020SA256510 and 2020SA256506.  This case involves a 20 years old female patient who was administered with an expired 0.5 mL dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Lot number: UJ295AA, expiration date: 30-Jun-2020) via intramuscular route at an left deltoid on 16-Sep-2020 for prophylactic vaccination (expired product administered).  Medical history, past medical treatments, past vaccination and family history were not provided.  Concomitant: None.  This was an actual medication error case due to expired vaccine used (latency on the same day).  Symptoms: None reported.  Reported asked do they need to revaccinate the patient and would like to know what needs to be done next.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
A physician reported that a male pt received an injection of Prevnar on an unspecified date and experienced drug ineffective, tonsillitis, strep infection, and decreased immune deficiency. The pt's concurrent illness includes developmental delay with a past history of recurrent infections. The reporter indicated that the child has an increased pain threshold. The reporter stated that the child has a history of "multiple problems." The pt received a dose on an unspecified date. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Pt was not taking concomitant therapy. An antibody test was performed on an unspecified date, the results revealed no antigenic reactivity after Prevnar injection. The physician, a geneticist and consultant, reported that the child has not responded to the Prevnar vaccine. The pt has had several "strep infections" including tonsillitis after receiving the vaccine. The pt has had several "strep infections" including tonsillitis after receiving the vaccine. The reporter stated that he is attempting to determine the "problem with the child's immune response." The physician indicated that he considers the events unrelated to the administration of Prevnar. This case was considered medically important (OMIC). No additional info was available at the time of this report.
This spontaneous report as received from an other health professional (healthcare worker) refers to unspecified number of unspecified patients. On unspecified dates since 28-OCT-2014 the patient received unspecified number of doses of GARDASIL, intramuscular, which had been improperly stored. The patients experienced incorrect product storage as all of them received improperly stored GARDASIL. No adverse effects were reported. No product quality complaint (PQC) was involved. Outcome of the event incorrect product storage was unknown. Reporter considered the event incorrect product storage to be not related to GARDASIL. This is one of several reports received from the same source (MARRS # 1502USA002229). Additional information has been requested.