chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (horrible pain in the heart area, chest, left side), BACK PAIN (horrible pain in back), MOBILITY DECREASED (couldn't change side when she was lying on bed), DYSPEPSIA (susceptible to heartburn.) and PAIN IN EXTREMITY (mild soreness in the arm) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A, 007AM20A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), FAMOTIDINE, ALPRAZOLAM (XANAX), ALPRAZOLAM (XANAX), AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Dec-2021, the patient experienced CHEST PAIN (horrible pain in the heart area, chest, left side), BACK PAIN (horrible pain in back), MOBILITY DECREASED (couldn't change side when she was lying on bed), DYSPEPSIA (susceptible to heartburn.), PAIN IN EXTREMITY (mild soreness in the arm), FEELING ABNORMAL (stabbing feeling on the left), FEAR (scary) and PAIN (shooting pain through the heart). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, CHEST PAIN (horrible pain in the heart area, chest, left side), BACK PAIN (horrible pain in back), MOBILITY DECREASED (couldn't change side when she was lying on bed), DYSPEPSIA (susceptible to heartburn.), PAIN IN EXTREMITY (mild soreness in the arm), FEELING ABNORMAL (stabbing feeling on the left), FEAR (scary) and PAIN (shooting pain through the heart) outcome was unknown. Treatment Self medicated with Tylenol and a muscle relaxant. Patient said that she omitted Adderall.
The doctor told the patient to wait 3 months to get the second dose; tested positive for Covid 19 after receiving the first dose of the Pfizer Covid 19 vaccine; This is a spontaneous report from a Pfizer-sponsored program, support from a contactable pharmacist. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EP7534; Expiration Date: 31Jul2021), intramuscular, administered in arm left on 18Mar2021 (at the age of 47-years-old) as 1st dose, 0.3 ml single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Pharmacist had a 47-year-old female patient who tested positive for Covid 19 after receiving the first dose of the Pfizer Covid 19 vaccine on 18Mar2021. Her doctor said to wait 3 months before getting the second dose of the vaccine. Pharmacist is trying to get the patient to come in for it now however she is hesitant. Was asking if it is okay to get it now and if it is suggested to wait 2 or three months after testing positive to get it. The doctor said to wait two months before getting the next dose. Was asking if the patient should get the vaccine and if it is suggested to wait 2 months after testing positive for Covid. The patient was told that she needed to wait three months and is hesitant to get it. The pharmacist suggests she get the vaccine. The patient does not have any no long-term effects and is isolated. She is super nervous. There was nothing on the web about this. A couple of different doctors said a couple of different things. The patient has recovered and no lingering symptoms. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 21Mar2021. The outcome of the event was recovered on an unspecified date in 2021.  Information on lot/batch number was available. Additional information has been requested.
Swollen throat glands, swollen arm, hives, itching and burning and stinging, swollen muscle
This spontaneous report as received from a nurse refers to unspecified patients of unknown demographics. No information about medical history concurrent conditions and concomitant medications was reported. The reporter stated that it is possible that ROTATEQ (dose strength, route, was not reported) dose was administered to the patients on an unspecified date after a cumulative temperature excursion of 123 hrs at 10C. No adverse effect reported. The outcome of the events reported is unknown. No product quality complaint was involved. Nurse also informed that with multiple excursion for three different sites with the vaccine reported. Nurse requested letter of evaluation data by e-mail to her. It was also reported that adverse event was filed as one site may have administered product involved in cumulative excursion. No product quality complaint. 10C was sum or total 122.5 hours ROTATEQ no, product was received January 2014. 51 hours at 10C ROTATEQ No.1.2C for 11 hours ROTATEQ yes. This case is linked to the cases 1404USA015151, 1404USA005087, 1405USA005088 via same reporter link. Additional information is not expected.
patient was given the Dtap/IPOL portion of the vaccine without HIB component with no reported adverse event; failing to mix both components of the vaccine and was administered as 2 separate injections with no reported adverse event; Initial information received on 30-Dec-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 15 months old male patient who was given the dtap/ipol portion of the vaccine without hib component with no reported adverse event and failed to mix both components of the vaccine and was administered as 2 separate injections with no reported adverse event after receiving Diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [pentacel (vero)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 30-Dec-2022, the patient received a (Series-4)dose of suspect Diphtheria/tetanus/5 hybrid ac Pertussis/ipv(vero)/hib(prp/t) vaccine(Dose-0.5mL)(Frequency- Total)( Strength = standard)(Formulation: Suspension for injection)( Drug Treatment Duration: NA)( Lot # UJ682AA, U7331AA) via intramuscular route in the left thigh (Left thigh Dtap-ipv, right thigh) for Immunization.  On 30-Dec-2022 the patient developed a non-serious events patient was given the dtap/ipol portion of the vaccine without hib component with no reported adverse event (incorrect product formulation administered), failing to mix both components of the vaccine and was administered as 2 separate injections with no reported adverse event (product preparation error)  following the administration of Diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine.(Latency-same day)  It was reported HIB PORTION o Dose = 0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test 0.25 mL. Indications = Immunization or TB skin test. Strength = standard except for Fluzone High Dose Quadrivalent. Nurse states that she gave the patient the HIB vaccine in the other leg.  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 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.
Tested COVID+ on 8/18/21, hospitalized on 8/24/21 with Shortness of breath requiring 2L oxygen.
Received the first dose on 05Mar2021, unable to receive the second dose of the vaccine in time because she was traveling; Arm soreness; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Arm soreness) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the first dose on 05Mar2021, unable to receive the second dose of the vaccine in time because she was traveling) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the first dose on 05Mar2021, unable to receive the second dose of the vaccine in time because she was traveling). On 08-Mar-2021, PAIN IN EXTREMITY (Arm soreness) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the first dose on 05Mar2021, unable to receive the second dose of the vaccine in time because she was traveling) outcome was unknown.        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.   No concomitant and treatment medication information was reported.
Strong pain in injection arm; Chills; Sweats; Full body aches; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 40 year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular, administered in left arm, administration date 30Nov2021 at 12:00 (Lot number: 330308BD) at the age of 40 years as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 30Nov2021 at 23:00, outcome "recovering", described as "Strong pain in injection arm"; CHILLS (non-serious) with onset 30Nov2021 at 23:00, outcome "recovering", described as "Chills"; HYPERHIDROSIS (non-serious) with onset 30Nov2021 at 23:00, outcome "recovering", described as "Sweats"; PAIN (non-serious) with onset 30Nov2021 at 23:00, outcome "recovering", described as "Full body aches"; HEADACHE (non-serious) with onset 30Nov2021 at 23:00, outcome "recovering", described as "Headache". Therapeutic measures were taken as a result of pain in extremity, chills, hyperhidrosis, pain and headache which included over the counter (OTC) Advil.  Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.
Pt received Hep-B #1 and PPD on 1/8/03. Pt awoke at 02:00 the following AM c/o abdominal cramping, nausea and dizziness. Pt self medicated with tablet Pepto-Bismol with turned her tongue black. Returned to clinic on 1/9/03 for evaluation. Pt denies any complaints of nausea or cramping on 1/10/03 and dizziness improved.
This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced a hard lump in arms. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from a hard lump in arms. This report was non-serious.
is arm was sore following the vaccinations; This spontaneous report as received from a pharmacist on 05-OCT-2021 refers to a male patient of unknown age.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On 01-OCT-2021 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (dose regimen details, indication, lot # and expiration date were not provided).  Other suspect therapies included influenza vaccine and varicella zoster vaccine rge (cho)(SHINGRIX) (dose regimen details, indication, lot # and expiration date were not provided).  On the same day, the patient experienced soreness in the arm..  The outcome of the event and the causality assessment were not provided.
Itch in the injection site; Redness in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itch in the injection site) and VACCINATION SITE ERYTHEMA (Redness in the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.     On 14-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced VACCINATION SITE PRURITUS (Itch in the injection site) and VACCINATION SITE ERYTHEMA (Redness in the injection site). The patient was treated with ALCOHOL for Itchy, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Itch in the injection site) and VACCINATION SITE ERYTHEMA (Redness in the injection site) outcome was unknown.            Patient took unknown concomitant medication for blood pressure.
Vaccine was administered at 9:35. at approximately 9:40 pt. reported " I am dizzy and I see trails", RN had pt. sit down. Pt became diaphoretic was unconscious for less than 30 seconds.  Ice pack was applied to back of his neck and bottle of water was offered. Pt reported he felt better. Pt than became diaphoretic and reported feeling "dizzy" Nursing staffed called EMS at 9:42 and EMS arrived on scene at 9:45  EMS observed and evaluated patient. Pt's father was present and called patient's mother who declined allowing EMS to take patient to hospital. Patient was escorted to personal vehicle by father and EMS.
The pt became faint after the vaccines were administered, The pt experienced sweating, cold skin, shaking, paleness, dizziness. Treated with Benadryl and rest.
13Jan98 Pt recv 1 dose vax. 19Jan98 Pt devel approx 50 lesions, malaise & low grade fever.
I had the shingles vaccination and later had shingles/suspected vaccination failure; extremely severe version of shingles; This 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had the shingles vaccination and later, had an extremely severe version of the shingles for 2 months.  The vaccine could not help but wonder if the vaccine caused the patient to get the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available.
weakness; shoulder and lower back pain; shoulder and lower back pain; fatigue; having shortness of breath; loosing her voiced; This is a spontaneous report from a contactable consumer, based on information received by Pfizer(manufacturer control number: EC-2021-089111), for BNT162B2. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date, as unknown, single dose for COVID-19 immunization ; lenvatinib mesilate (LENVIMA), via an unspecified route of administration from 26Feb2021 (Batch/Lot number was not reported) to an unspecified date, at 20 mg, daily for endometrial cancer. Medical history included ongoing blood pressure increased , endometrial cancer from an unknown date and unknown if ongoing receiving radiation. The patient's concomitant medications were not reported. Patient reported that on08May2021, she has not been feeling lately and has been having shortness of breath, weakness, loosing her voiced and healthcare provider prescribed her with Steriod but patient was unsure of the name or dosage of the steriod as her daughter normally takes care of her medications. Patient previously reported continued increased blood pressure and patient went to the Emergency Room about a week ago (around 22Mar2021) for increased blood pressure as previously reported and patient had continued to have fatigue and headaches since starting Lenvima as well (symptom onset around 26Feb2021). Patient previously voiced that since starting Lenvima she has continued to have weakness, shoulder and lower back pain as well as fatigue, but patient was unsure if that was also due to receiving radiation and first COVID vaccine just prior to starting Lenvima. Diagnosis: Endometrial Cancer C54.1. The outcome of the events was unknown.
Expired Vaccine used; Product storage error; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) and PRODUCT STORAGE ERROR (Product storage error) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) and PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment  medications were reported. Date of refrigeration was reported as 03-Nov-2021.
DIARRHEA; This spontaneous report received from a patient concerned a 78 year old female. The patient's weight was 120 pounds, and height was 65 inches. The patient's past medical history included: dog bite, and concurrent conditions included: bipolar disorder, asthma, apples, eggs, chicken, wheat, all fruits (except carrots, potatoes, asparagus), lima beans, abstains from alcohol, and non-smoker, and other pre-existing medical conditions included: The patient not experiencing any soreness in arm. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 19-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 20-AUG-2021, the patient experienced diarrhea. Treatment medications (dates unspecified) included: electrolytes nos/glucose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from diarrhea. This report was non-serious.
pt recvd vax; uncontrolled crying from 6pm to midnoc inspite of apap, followed by lethargy;
NEUROPATHY 9/4/2022 & 9/27/2022 -- RECURRENCE OF SAME SYMPTOMS
Patient was given Pfizer Bio Tech 5-11years old instead of Pfizer Bio Tech 12 years old
Information has been received from a physician concerning an 11 month old male who on an unspecified date was vaccinated with 2 doses of hepatitis B virus vaccine (+) HIB conjugate vaccine. The physician reported that he did not think the patient had received the proper HIB dosing. The physician reported that to my knowledge the child did receive 2 doses of hepatitis B virus vaccine (+) HIB conjugate vaccine and had not yet received the booster dose. On an unspecified date the patient developed Haemophilus Influenzae Type B epiglottitis. On an unspecified date the patient was hospitalized and treated. At the time of this report, the outcome of the event was unknown. Additional information has been requested.
Rcn started approx 1:45 am on 10/11/08-ears began to swell and progressed to cheeks and eventually to throat (soreness). Pt sought medical care approx noon on 10/11 was given BENADRYL- Condition has improved. She will be seeing an allergist for F/u. (Pt has had similar experience with NAPROXEN and DIAMOX)
began with site pain, redness and swelling turning to hard lump 4 inch circular and 1/2 inch protruding in 4 hours - headache and light perspiration in 5 hours - exhaustion, intestinal distress and light vertigo in 7 hours - disoriented in 8 hours, losing track of activity and thoughts - difficulty sleeping for arm pain with added joint pain - next morning all same symptoms with increase disorientation and unable to drive, cook, do most tasks with little recall of full day or night - better sleep second night - next day less headache, no intestinal distress, less arm pain and swelling, no joint pain but unable to focus or recall most of activities in day - third night sound sleep - next day  much improved arm but new itching sensation that worsened, better mental ability but remained exhausted - fourth night difficult sleep with injection site itching but less swelling - next morning decreased itching, better mental and energy returned - foggy mind continued two more days while all pain subsided and itching gone by 6th day - bump remains at injection site
Swelling over left clavicle, probably lymph node according to my doctor.  I still have it.  Also-Approximately 10 days after the initial vaccination, my arm had a large red welt that was hot to the touch that took about a week to resolve.
This spontaneous report as received from a Certified Medical Assistant refers to unknown number of patients of unknown demographics. There was no information about the patients' concurrent conditions, concomitant therapies, drug reactions or allergies and medical history provided. On unknown dates, the patients were inadvertently administered GARDASIL 9 (lot # M016193, expiration date 24-APR-2018, route of administration and dose were not reported) that had been improperly stored. No adverse effects were reported. The vaccine experienced a temperature excursion of 47 Fahrenheit degrees (F) for 5 minutes, which was detected by a digital data logger. There was no previous temperature excursion. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish to be contacted. Sender's Comments: US-009507513-1701USA002060: US-009507513-1701USA002061: US-009507513-1612USA012239.
pt recvd vax;began itching in arm, shoulders, back & legs and top of feet;face became flushed; hands tingly & throat dry; pt given dph;
I developed Bell's Palsy 12/09/2021 after I received the Moderna vaccine 10/05/2021.