chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received a first dose of Menveo on 6-11-2020 and received second dose of Menveo on 6-12-2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 14-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Previously administered products included Menveo (On 11th June 2020, received first dose (0.5 ml) intramuscularly on unknown arm).   On 12-JUN-2023, the patient received the 2nd dose of Menveo (intramuscular, unknown arm) .5 ml. On 12-JUN-2023, an unknown time after receiving Menveo, the patient experienced drug dose administration interval too long (Verbatim: Patient received a first dose of Menveo on 6-11-2020 and received second dose of Menveo on 6-12-2023). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 13-JUN-2023 The reporter did consent to follow up. The patient received 2nd dose of Menveo late than recommended time frame, which led to lengthening of vaccination schedule.
Shot at 11:30am.  Soreness in arm developed within a few hours.  Difficulty staying asleep.  Extremely drowsy upon waking at 7:30am (20 hours post vaccination) with general malaise and headache.  Headache persisted throughout day.  Despite multiple temperature checks through day, no fever (97.6 average temp).  40 hours post vaccination (Monday morning) started displaying symptoms of depression including uncontrollable emotions, loss of interest, daytime drowsiness, irritability and insomnia.  Had a coincidentally scheduled counseling appointment the Monday following vaccination and discussed newly developed depressive symptoms but did not change medication levels.  Depressive symptoms persisted for the next three days and subsided 120 hours after vaccination (Thursday evening).   Felt "normal" by Sunday April 4, eight days after vaccination.
according to mom, pt rant 105 ax temp PM p/vax;AM 27MAR97 mom reports pt had bulging fontanel;advised to go to PMD now;was adm per MD to hosp & was treated;d/c 30MAR97;
I got shingles after getting the vaccine; I got shingles after getting the vaccine; This serious case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I got shingles after getting the vaccine) (serious criteria GSK medically significant) and shingles (Verbatim: I got shingles after getting the vaccine). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-Mar-2023 The patient got shingles after getting the vaccine. The reporter said you could get them do not believe everything you were reading. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Pt complained of fever (unable to take at hm. for accurate temp reading), weakness in body, headache, described S/S as "Flu-like" per pt. started at 3AM 2-23-16, pt got vaccine for travel at end of yr. Was advised to take TYLENOL for fever.
brain fog; left arm injection site was sore; fatigue; body aches; fever; chills; fatigued/Tired; body aches; left arm injection site was sore; This spontaneous case was reported by a patient and describes the occurrence of DEPRESSED LEVEL OF CONSCIOUSNESS (brain fog) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history per source document.). Concomitant products included PARACETAMOL (ACETAMINOPHEN) for an unknown indication.    On 20-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced the first episode of VACCINATION SITE PAIN (left arm injection site was sore), FATIGUE (fatigued/Tired) and the first episode of MYALGIA (body aches). On 20-May-2021, the patient experienced FATIGUE (fatigue), the second episode of MYALGIA (body aches), PYREXIA (fever), CHILLS (chills) and the second episode of VACCINATION SITE PAIN (left arm injection site was sore). On 24-May-2021, the patient experienced DEPRESSED LEVEL OF CONSCIOUSNESS (brain fog) (seriousness criterion medically significant). On 27-Apr-2021, FATIGUE (fatigued/Tired) had resolved. On 23-May-2021, FATIGUE (fatigue), the last episode of MYALGIA (body aches) and the last episode of VACCINATION SITE PAIN (left arm injection site was sore) had resolved. At the time of the report, DEPRESSED LEVEL OF CONSCIOUSNESS (brain fog), PYREXIA (fever) and CHILLS (chills) outcome was unknown.            Patient received both Moderna Covid-19 vaccine in his left arm shoulder deltoid muscle.  Action taken with mRNA-1273 in response to the events was not applicable.  Treatment medication was not provided.  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: 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 initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. During 2016, the patient was inoculated with ZOSTAVAX at a pharmacy for routine adult health maintenance and the intended purpose for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine is intended to prevent. On or about 01-JUN-2016, the patient was treated at a hospital for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles.  As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, she has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcomes of vaccination failure and herpes zoster were unknown. The lawyer considered vaccination failure and herpes zoster to be related to ZOSTAVAX. Additional information has been requested.
Pt called and came to clinic for evaluation due to Tdap vaccine reaction, 7 x 4 1/2 inches, redness/induration, tenderness since 10/27/10. Pt started on ZYRTEC on 10/27/10. BENADRYL 50mg p.o. 10mg 6-8hrs prn given by MD and referred to Urgent Care.
sore arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were received as follows: The age at vaccination was not applicable for this report. The reporter stated that, almost everyone complained of a sore arm after Flu shot similar to what people feel after the flu shot. The reporter did not consented to follow up.  The reporter could not provide any additional details regarding patients.  This case was linked with case US2020050262 (Shingrix vaccine case), reported by the same reporter.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 15Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FJ4989) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 25Feb2021 as dose 1, single (Lot number: 015m20A), on 25Mar2021 as dose 2, single (Lot number: 018B21A) and on 23Oct2021 as dose 3, single (Lot number: 058e21A) for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing). Concomitant medication(s) included: CRESTOR; LOSARTAN; LEXAPRO. 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: Negative; Positive. Therapeutic measures were taken as a result of covid-19.  Clinical Course: Anti viral details: Product COVID 19 Treatment, brand Pfizer, treatment start date on 01May2022, treatment stop date on 06May2022, indication, treatment of COVID-19. The patient was prescribed Paxlovid as for 5 days it worked to help with the symptoms. On day 9 of infection he was finally tested totally negative on home antigen test then day 10 tested strong positive and all symptoms came back stronger than before still testing positive on day 11.  No follow up attempts are possible. No further information is expected.
mild soreness at injection site which lasted for 2 days; This is a spontaneous report from a contactable Other HCP. A 28-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9262) dose 1 via an unspecified route of administration, administered in Arm Left on 24Jan2021 11:00 (at the age of 28 years old) at dose 1, single for covid-19 immunisation. Medical history included ongoing rhinitis allergic and uterine leiomyoma from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient previously took feraheme and experienced drug hypersensitivity. The patient received other medications within 2 weeks of vaccination. On 24Jan2021, the patient experienced mild soreness at injection site which lasted for 2 days. The patient was did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was not recovered on an unspecified date 2021.   Follow-up (13May2021): Follow-up attempts completed. No further information expected.
On March 1st 2021 I got the shot and on my way home I got bumps from my head to my toes. I took two Benadryl and went to the bed. I woke up not feeling well but went on with my day then on March the 3rd I had an increased heart rate and went to the hospital. I was at the hospital for three days. They put me on blood thinners and really this shot created a mess. I am wearing a heart monitor now today.
This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a 5-year-old male patient who received Flu vaccine Quadrivalent. On an unknown date, the patient received Influenza vaccine Quadrivalent. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to Influenza vaccine Quadrivalent. Additional information was reported as follows: The age at vaccination was not reported. The patient had a reaction to the flu vaccine in 2015 (unknown manufacturer). This case has also been linked with case US2017189700, reported by the same reporter for the same patient.
Pt received two shots on 9/24/18. FLUZONE was in right arm and PNEUMOVAX in the left arm. She states that 2 to 3  hours after receiving shots her left arm showed redness and became warm to touch. She experienced pain and saw a doctor on 9/25/18. He prescribed Amoxicillin 250mg three times daily for 5 days.
Pt is a 33 y/o female receiving 1st dose of Moderna vaccine today. Pt reported tingling in her left arm. Pt received vaccine in left deltoid. Pt has circulation and sensation present w/ full ROM.  Symptoms reported as minor. No other symptoms reported. All Pt questions were asked and answered.  Pt released w/ instructions to contact PCP if symptoms worsen  or do not go away.
Muscle tension all over body especially in neck, back, low back, and arms. Intense headache and fatigue. Sore injection site, tender to the touch.  Moments of Dizziness and zoning out.
No other adverse events reported; improperly stored MMR II were administered; This spontaneous report was received from a registered medical assistant (RMA) and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 28-SEP-2021, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) 1 dose, lot # T016197, expiration date 11-MAY-2022 (exact dose, dose number, vaccination site and route of administration were not provided) for prophylaxis.  Administered dose of vaccine was exposed to the temperature excursions of 10.5 degrees Celsius for 6 hours and 46 minutes and 8.5 degrees Celsius for 1 hour and 24 minutes. There was no previous temperature excursion. No other adverse events were reported.  This is one of two reports received from the same reporter (cross-referenced with US-009507513-2109USA007552).; Sender's Comments:  US-009507513-2109USA007552:
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Herpes, allergies" (unspecified if ongoing), notes: Herpes, allergies; "allergies" (unspecified if ongoing), notes: allergies. Concomitant medication(s) included: ACYCLOVIR [ACICLOVIR SODIUM]; LORATADINE. Vaccination history included: Covid-19 vaccine (Dose Number: 2, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose Number: 1, Manufacturer: Unknown), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Paxlovid: Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, Covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Started with mild body aches and fatigue and inflamation & swelling at the injection site.  This was the day after receiving the Tetanus vaccine.  On Friday the 16th I along with the avove effects I also developes swollen glands, hives, chills and a temperature of 102.6 at which point I started a recement of Tylenol and Benedryl which reduced the fever and inflamation. Continued to run a mild fever on Saturday the 17th of 100.4 which subsided completely by Sunday the 18th.  To date I still have very minor glandular swelling & swelling at injection site.  All other symptoms have disappeared
I am not sure if this is related to Vaccine howvever my period was 45 days late.; administration_date=03/Mar/2021 administration_date=21/Mar/2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 21Mar2021 11:00 (Lot number: ER8730) at the age of 52 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "bees" (unspecified if ongoing), notes: Known allergies: bees and Bayshrimp; "Bayshrimp" (unspecified if ongoing), notes: Known allergies: bees and Bayshrimp. The patient's concomitant medications include cholesterol meds. Vaccination history included: Bnt162b2 (Product: COVID 19, Brand: Pfizer, Lot number: EN6203, Lot unknown: False, Administration date: 03Mar2021, Administration time: 01:00 PM, Dose Number: 1, Vaccine location: Left arm), administration date: 03Mar2021, when the patient was 52 years old, for Covid-19 immunisation, reaction(s): "My period was 45 days late". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 21Mar2021, outcome "unknown", described as "administration_date=03/Mar/2021 administration_date=21/Mar/2021"; MENSTRUATION DELAYED (non-serious), outcome "recovered", described as "I am not sure if this is related to Vaccine howvever my period was 45 days late.". Therapeutic measures were not taken as a result of inappropriate schedule of product administration, menstruation delayed.  Additional Information: The patient did not receive other vaccine in four weeks. Patient did not experience covid prior to vaccination. Patient was not tested for covid post vaccination. Patient stated that she went to doctor thinking she was going through menopause due to her age. However she was confused that her period just stop them. Her period started back up 45 days late. Her last period was on 07Feb before it came again on 22Apr.   No follow-up attempts are possible. No further information is expected.
inappropriate schedule of vaccine administered; Irregular menstrual cycle now; Swelling in lymph nodes; developed a wet, raspy cough; This is a spontaneous report from a contactable nurse (patient). A 45-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN5318), via an intramuscular route of administration, administered in left arm on 05Feb2021 09:00 (at the age of 45-years) as dose 1, single for COVID-19 immunization. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL1283), via unspecified route of administration, administered in left arm on 05Feb2021 as dose 2, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medications taken in two weeks included ibuprofen (MOTRIN) taken for an unspecified indication, start and stop date were not reported and PROBIOTIC taken for an unspecified indication, start and stop date were not reported. The patient previously took Augmentin and experienced drug hypersensitivity, Acrylic and experienced drug hypersensitivity, Demerol and experienced drug hypersensitivity, Dilaudid and experienced drug hypersensitivity. The patient did not receive any other vaccine in four weeks. Prior vaccination patient did not have COVID-19. On 11Feb2021, patient experienced swelling in lymph nodes, developed a wet raspy cough, Irregular menstrual cycle. The adverse events resulted in visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. On 17Mar2021, the patient underwent nasal swab (SARS-CoV-2 test), and the test result was negative. Patient did not received treatment for adverse events. The outcome of the events was not recovered.
slight pressure in the front of my head; lightheaded spells; fast heart beat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 33 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 22Oct2021 15:00 (Lot number: 320308D) at the age of 33 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: Verbatim: High blood pressure. The patient took concomitant medications. The following information was reported: HEAD DISCOMFORT (non-serious), outcome "unknown", described as "slight pressure in the front of my head"; DIZZINESS (non-serious), outcome "unknown", described as "lightheaded spells"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "fast heart beat". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of head discomfort, dizziness, heart rate increased. Additional information The patient had been having since the first shot just over 2 weeks ago slight pressure in the front of head and lightheaded spells. He did experience a fast heart beat when had the lightheaded spells. No treatment and this has been going on since that shot its been constant for 2 weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a registered nurse and refers to a 20 year old male patient. Medical history and concomitant medications were not reported. The patient received his first dose of GARDASIL on 05-AUG-2013 and his second dose on 24-NOV-2014. No adverse experience was observed. Additional information has been requested.
Pt tolerated shot well at time of injection, but after 5 days then pt had notable swelling, redness and pain at site with warmth. No fever. Pt has been taking TYLENOL and drinking fluids. Reaction was delayed c/o nausea and weakness. Denies SOB, vomit or fever.
About 1 minute after the flu shot was administered, patient stated that he felt dizzy. He sat down on a chair with a glass of fluid in his hand. After a few minutes, he became unresponsive. 911 was called. Within a minute, he awoke with no knowledge of his blackout. We laid him down on the floor with his feet elevated on a chair, and he stated that he felt much better. He remained on the floor until the ambulance arrived. He was then seated in a chair and he starting sweating profusely and his BP was low. He was carted and taken to the ER where he was diagnosed with a vagal response possibly due to being afraid of needles. He was fine the next day around 10 AM when I talked to him.
Approx. 1 week, post vax, the pt developed fever, rash, chickenpox, behavior changes, paleness, weakness, hoarseness and swelling of glands.
arm is sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    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 PAIN IN EXTREMITY (arm is sore). At the time of the report, PAIN IN EXTREMITY (arm is sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment was reported for the events.