chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diarrhea; Cough; Loss appetite/no hungry; Sleep a lot; Tired; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), DECREASED APPETITE (Loss appetite/no hungry), HYPERSOMNIA (Sleep a lot), DIARRHOEA (Diarrhea) and FATIGUE (Tired) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced DECREASED APPETITE (Loss appetite/no hungry), HYPERSOMNIA (Sleep a lot) and FATIGUE (Tired). On 07-Feb-2021, the patient experienced COUGH (Cough). On 08-Feb-2021, the patient experienced DIARRHOEA (Diarrhea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COUGH (Cough), DECREASED APPETITE (Loss appetite/no hungry), HYPERSOMNIA (Sleep a lot), DIARRHOEA (Diarrhea) and FATIGUE (Tired) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment medication included Tylenol and Rubinstein.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Follow up received on 26APR2021, updated reporter details and 2nd dose details
Vaccine Administration Error: Client was given adult Havrix/Hep A vaccine instead of what she should have received, Pediatric Havrix.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Oct2022 at 11:00 as dose 5 (booster), single (Lot number: GH9697) at the age of 62 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Reactive airway" (unspecified if ongoing); "Bronchitis" (unspecified if ongoing); "Over weight" (unspecified if ongoing); "combination pain medications" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Levaquin, reaction(s): "Known allergies: Levaquin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid (start date: 12Jul2023 and stop date: 16Jul2023.; Sender's Comments: Based on the information in the case report and known drug safety profile, a possible causal relationship between the events Drug ineffective, COVID-19 and suspect product cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202300257123 Same patient, different drug, different event;
Vx expired on 11/07/2021 was administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-month-old male patient who received Hib (Hiberix) (batch number 3DK94, expiry date 7th November 2021) for prophylaxis.   On 1st December 2021, the patient received Hiberix. On 1st December 2021, unknown after receiving Hiberix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were reported as follows: The patient received dose of Hiberix that already got expired on 7th November 2021, which led to expired vaccine used. Health care professional gave consent for the safety team to follow up. The reporter consented to follow up.
One day following vaccine pt developed malaise and body aches; she had mental status change 6 days later and was found by family in bed 8 days later lying in feces and urine. She has no recollection of time period between 6 and 9 days after vaccine. Hospitalization could not determine reason for mental status change.
Arm swelled significantly from shoulder to elbow, skin from shoulder to elbow very red and hot to the touch.
headache; This is a spontaneous report received from a contactable consumer reported for herself. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at single dose on 2021 for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the first dose of the vaccine on Thursday and developed a headache on Saturday. Outcome of the event was unknown. The case was reported as non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
sore arm; This is a spontaneous report received from a contactable (patient). A male patient of an unspecified age (reported as "51", unit not provided, pending clarification) received BNT162B2 (BIONTECH COVID-19 VACCINE lot number and expiry date not provided), via an unspecified route of administration, on 07Jan2021, at single dose, for COVID-19 immunization. Medical history included ongoing glucose-6-phosphate dehydrogenase (G6PD) deficiency. The patient reported that he and his brother both have G6PD. The patient's concomitant medications were not reported. The patient received the vaccine last Thursday, 07Jan2021, and experienced sore arm on an unspecified date in Jan2021. The patient was wondering if he and his brother are eligible to receive the vaccine, or if there is any data on the vaccine and people with their condition. The outcome of the event was unknown.  Information about lot/batch number has been requested.
All events occurred the day after my shot. Fever of 100.8 at 3:45am until 9:30am, chills and body aches all day, major fatigue, arm pain in the deltoid and shoulder joint, inflammation and pain in the armpit, and headaches with eye aches.
late dose; Malaise; Body aches; This case was reported by a physician via sales rep and described the occurrence of malaise in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In November 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient received the 2nd dose of Shingrix. In November 2018, immediately after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced malaise and general body pain. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the malaise and general body pain were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the malaise and general body pain to be related to Shingrix.  Additional case details were provided as follows: Soon after receiving a dose of Shingrix, the patient began to experience significant malaise and body aches and due to which she had to stay in bed for 48 hours. From the reported information, it seems that, till the time of reporting, the patient did not receive her 2nd dose, which led to an incomplete course of vaccination. All symptoms were resolved after 48 hours. The sales representative indicated that, the reporter provided this information to her during a Congress she was attending and was unable to provide any additional details. This is 1 of the 4 cases reported by the same reporter. There was a discrepancy in the reported outcomes of the events body aches and malaise. In XML, outcome was mentioned as recovered/resolved with sequel and in Argus, it was reported as recovered/resolved. However outcome of these events is captured as per Argus.
Severe pain and heat radiating down right leg from the lower back down the buttock and front of right thigh
Client relates that on Saturday her right arm started to get very red, itchy and swell. The swelling and redness got worse over the weekend and she went to Urgent Care on campus as school today Monday April 17,2023.Client states that she has been taking  Ibuprofen and Benadryl 25 mg tablets every 8 hours. Client states that the Urgent care as instructed her to continue with what she has been doing and to call the clinic that gave her the shot. Client denies any other symptoms.
Patient is a very pleasant 31-year-old white male who previously healthy, he works with a maintenance crew, he was in his usual state of health last week, he did receive his 2nd dose of the COVID-19 Moderna vaccine on Thursday.  Over the next 24-48 hours he began experiencing myalgias malaise and fatigue, he self treated with ibuprofen and Tylenol as needed.  He felt a little bit better on Sunday and went to assist in picking up a brush more.  During the process he became  short of breath as well as midsternal chest discomfort. He presented to the ED.    Evaluation found a CRP of 112, elevated troponins and a  leukocytosis of approximately 20,000 along with elevated neutrophils.  His influenza a and influenza B testing have been negative and his SARS COVID the PCR was negative.  Given his elevated troponins, he was started on IV heparin and admitted for further evaluation.   On admission to the floor, he was chest pain free. We were concerned for potential myo/pericarditis given his history and laboratory study findings. Cardiac MRI was performed which suggested active myocarditis with biventricular systolic dysfunction (LVEF 34%, RVEF 37%). Given his new LV dysfunction he was started on low dose lisinopril and metoprolol succinate.  It is unclear whether this is atypical viral myocarditis or whether it potentially could be vaccine related, the MRI is consistent with that of myocarditis. We did not proceed with cardiac biopsy unless since there was no evidence for clinical decompensation, unstable heart rhythm or other worrisome features. He will plan to follow up with Dr. 1 week post hospitalization with repeat echocardiography and blood work.  If at that time there are any signs of instability we would proceed with more aggressive workup at that time.    Infectious disease was consulted who recommended infectious work up including serology testing for: parvovirus IgG and IgM was positive, Herpes Virus type 6, EBV, CMV (undetected) adenovirus, enterovirus (negative) and HIV (negative) .    He does not have any family history of cardiomyopathy.  There is no family history of sudden cardiac death, he states that his family has been quite healthy from a cardiac standpoint he was previously healthy before this episode.
Low grade fever and just didn't feel good. Body aches and wanted to lay down. The worst began on 2nd day after vacation. I don't remember taking anything to elevate the discomfort. Sleeping seemed to help the most. I had the low grade fever for four months. My doctor wanted to run test.
Hives on forehead/hives on right hand; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives on forehead/hives on right hand) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Bipolar disorder and Type 2 diabetes mellitus.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced URTICARIA (Hives on forehead/hives on right hand). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives on forehead/hives on right hand) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient developed hives on their right hand and forehead on 01-Apr-2021. On 14-Apr-2021, the hives on right hand and forehead have improved but were still present.  Reportedly, the patient took Benadryl as treatment medication.  Concomitant product use included unspecified medications for blood pressure, bipolar disorder and type-II diabetes mellitus.
When I woke up the day after (Day #2) being given the vaccine I was extremely tired exhausted, I had intense chills and hot flashes. Never a fever. I felt nauseated. Completely lethargic. Muscle aches all over my body, was hard to move. I couldn't stay awake. My eyes hurt. I had intense migraines.  And no appetite. My right arm hurt, but not as bad as many others' reported.  I took ibuprofen to help, it didn't. I drank lots of water and gatorade zero for the electrolytes. It didn't help either.  On day #3, this was when it got scary. The previous  symptoms carried over, minus the nausea and I was able to be mobile (less lethargic).  But something new started to happen. I took my dog out for a short walk, a slow pace, I am very athletic, and I had shortness of breath. I was winded from just walking slowly. Then the brain fog started to set in. This I hated the most. I wasn't able to comprehend things. I tried to assemble an item I bought from Amazon and it was extremely hard to follow simple instructions. I wasn't able to see clearly for some reason. And even comprehending emails that I was receiving was troublesome. I kept drinking water, and was able to eat a little. Had two more bottles of Gatorade Zero.  On day 3, most of all the symptoms subsided except that I still got winded from movement.  On day 4, I was fine.
This spontaneous report was received from the patient's mother and refers to a 2-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 04-DEC-2018, the patient was accidentally vaccinated with PNEUMOVAX 23 (Product administered to patient of inappropriate age) 1 injection for prophylaxis (lot #, expiration date and route of administration were not reported). No adverse effects were reported.
One week after I received the shot the injection site began to hurt again as it the next day after I received the shot.  Later that day it itched. The next morning, the injection site was red and swollen in a 2 inch diameter.  By the evening all symptoms disappeared and did not return.
felt more like a burning especially in my neck; Minutes after shot some sweating, first thought perhaps it is some anxiety related to having a vaccination. After monitoring period went back to the office. Started to get severe nausea; Minutes after shot some sweating, first thought perhaps it is some anxiety related to having a vaccination. After monitoring period went back to the office. Started to get severe nausea; Minutes after shot some sweating, first thought perhaps it is some anxiety related to having a vaccination. After monitoring period went back to the office. Started to get severe nausea; muscle pain that started in my neck, shoulder and then moved on to both legs; felt weak and had to go home; pain in my neck; leg pain; arm pain; This is a spontaneous report from a contactable Nurse. This Nurse reported for self that the 50-year-old female patient received first dose of bnt162b2 (BNT162B2, reported as PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via Intramuscular on left arm on 18Dec2020 03:15 PM at single dose for covid-19 immunisation. She is not Pregnant at the time of vaccination. Medical history included Known allergies to medications, food, or other products: Dust mites, nickel and recent iron deficiency anemia, esophageal ulceration, reactive airway disease. Concomitant medications included other medications the patient received within 2 weeks of vaccination included Omeprazole 40 mg BID (Twice a day), colecalciferol (VITAMIN D [COLECALCIFEROL]) and Albuterol. Facility type vaccine was Hospital. No other vaccine in four weeks. No other vaccine in two weeks. The patient experienced "Minutes after shot some sweating, first thought perhaps it is some anxiety related to having a vaccination. After monitoring period went back to the office. Started to get severe nausea and muscle pain that started in my neck, shoulder and then moved on to both legs. I felt weak and had to go home. The muscle pain was not like exercise pain - it felt more like a burning especially in my neck. The pain in my neck got better after Tylenol , the leg pain continued until 10 pm. The nausea was severe until 7:30 and was gone by 10 pm. I had to leave work 2 hours early because of side effects. The arm pain continued for two days, locally, minor and was gone on day three (21Dec2020)". The event started from 18Dec2020 03:30 PM. The outcome of the events was recovered. No treatment received. No covid prior vaccination. No covid tested post vaccination. Facility where the most recent COVID-19 vaccine was administered was Hospital. 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. Since the vaccination, the patient has not been tested for COVID-19. The events were assessed non-serious.
Eye pain in right eye, blurry vision and floaters, started a few hours, post vax. It got better and the pain in my right eye woke me up in the middle of the night. Had cloudy vision and floaters all day on Sunday. Still have neck pain.
LGF noticed 2-3 hrs p/receiving vax dizziness, generalized malaise for several wks; accompanied by generalized shaking 20-30 seconds occurred 4x over 20 day period; also sharp abdominal pains; fever 101, disorientation & fatigue;
This spontaneous report was received from a physician, via a company representative, concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 04-APR-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 with lot # L007720 Expiration date: 08-JUL-2018, 0.5 ml (route and anatomical location of administration were not reported). On unspecified dates, the PNEUMOVAX 23 vaccine had six temperature excursions of 0 Celsius Degrees (32 Fahrenheit) for 328 hours, 0.55 Celsius Degrees (33 Fahrenheit) for 128 hours, -1.11 Celsius Degrees (30 Fahrenheit) for 288 hours, -1.66 Celsius Degrees (29 Fahrenheit) for 256 hours, -0.55 Celsius Degrees (31 Fahrenheit) for 552 hours, and 1.11 Celsius Degrees (34 Fahrenheit) for 72 hours, respectively. The vaccine status was reported as "in excursion" and the type of excursion and storage criteria were reported as "refrigerator (R)". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
FEVER; 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 not reported, batch number: Unknown) dose, start therapy date were not reported 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 subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
35 yo female received the first dose of the Moderna COVID-19 vaccination on 12/29/20. Received second dose on 1/27/2021. Pt undergoes COVID-19 testing with no known symptoms. Nasopharyngeal swab obtained 4/6 at 1550. Coronavirus PCR test resulted positive a few hours later. Pt meets the criteria to receive bamlanivimab/etesevimab infusion and receives this medication therapy on 4/7.
Received shot on 4/17 Saturday afternoon at 1 pm and on Monday morning 4/19 at ~9 am I started to get ringing in my ears.  Has not stopped.  Went to doctor and he has me start taking prednisone, still taking the steroids for the next 5-6 days.
skin was dry; chills; fever; rash on chest; This spontaneous case was reported by a patient and describes the occurrence of DRY SKIN (skin was dry), CHILLS (chills), PYREXIA (fever) and RASH (rash on chest) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DRY SKIN (skin was dry), CHILLS (chills), PYREXIA (fever) and RASH (rash on chest). At the time of the report, DRY SKIN (skin was dry), CHILLS (chills), PYREXIA (fever) and RASH (rash on chest) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was provided.  Patient had received second dose on 06 Mar 2021 and first booster on 22 Oct 2021.  Treatment medications included skin lotion which was used for dry skin.   Reporter did not allow further contact
Patient given multiple immunization 4/3/07. Patient brought in on 4/4/07 with blister at one injection site left deltoid region
Before this vax, patient was diagnosed with shingles 11 years prior and has herpes upon taking Zoster. No herpes or shingles outbreak. Valtrex is used for both. Wasn't taking Valtrex for 11 years because she recovered. Patient had Shingrix shot on 8/22 and experienced shingles and herpes outbreak. Takes the medicine and it goes away. When she does not take medication, her outbreak appears. Herpes on the lip, shingles on her back. "This shot is not working!!" Seen doctor and has appointment coming up. Also has part 2 of Shingrix vax coming up.
102 degree fever, chills, skin felt like it was "on fire", lasted 2-3 days.
Systemic effects post-smallpox vax beginning 3/2/03 and lasting approx 48 hrs. Consisting of fatigue, myalgia, low-grade fever, lymphadenopathy, headache, and malaise. Headache occurred from 3/2 to 3/7/03.
After first dose, got hives around injection site on left arm about 12 days later. Went away over night, but reappeared briefly a couple days later. After second dose, got same hives around injection site a couple days after vaccination. Comes and goes. On 2/22 got hives on left and right arms, back, and chest.
Given double dose IM in right thigh= total volume 1.0mL thought to have diluent vial + vaccine vial
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Minor sore arm) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Irritable bowel syndrome. Concomitant products included ATORVASTATIN and CITALOPRAM for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Minor sore arm). At the time of the report, PAIN IN EXTREMITY (Minor sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product was also taken for irritable bowel syndrome.  No treatment medication was provided.   This case was linked to MOD-2021-335133.