chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, 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: "Immunocompromised" (ongoing). Concomitant medication(s) included: ACTEMRA taken for immunodeficiency (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid from Jun2023 to Jun2023. Clinical course: Unknown for Other medication in 2weeks. Unknown Known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300227961 same patient, different drug/event;
lost weight; lack appetite; Patient is taken to the hospital with chest pain, it like a knife going in chest; arm pain; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (Patient is taken to the hospital with chest pain, it like a knife going in chest), WEIGHT DECREASED (lost weight) and DECREASED APPETITE (lack appetite) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.     On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-May-2021, the patient experienced CHEST PAIN (Patient is taken to the hospital with chest pain, it like a knife going in chest) (seriousness criterion hospitalization). On an unknown date, the patient experienced WEIGHT DECREASED (lost weight) (seriousness criterion hospitalization), DECREASED APPETITE (lack appetite) (seriousness criterion hospitalization), PAIN IN EXTREMITY (arm pain) and CHILLS (Chills). The patient was hospitalized on 09-May-2021 due to CHEST PAIN, DECREASED APPETITE and WEIGHT DECREASED. The patient was treated with BISMUTH SUBSALICYLATE, CALCIUM CARBONATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE;CALCIUM CARBONATE]) ongoing since an unknown date at a dose of UNK dosage form and CALCIUM CARBONATE (MYLANTA [CALCIUM CARBONATE]) ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, CHEST PAIN (Patient is taken to the hospital with chest pain, it like a knife going in chest), WEIGHT DECREASED (lost weight), DECREASED APPETITE (lack appetite), PAIN IN EXTREMITY (arm pain) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-May-2021, Electrocardiogram: normal (normal) arteries are clean and blood pressure is ok.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. The patient's concomitant medication included sterile diluent. On 21-FEB-2019, the patient was vaccinated with improperly stored VARIVAX (lot # R021098, expiration date was 23-JUL-2010; lot # R023502, expiration date: 16-AUG-2020; dose, route and frequency were unknown) for prophylaxis. The administered VARIVAX was stored under the temperature ranging from 6 Fahrenheit degrees to 14 Fahrenheit degrees (5.53 Fahrenheit degrees) for 15 minutes. The temperature excursion occurred as a result of a reading from a digital data logger. Moreover, there was no occurrence of previous temperature excursion. The sterile diluent used to reconstitute VARIVAX was stored appropriately. No adverse effects reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1902USA009575.
I have had nerve, joint and muscle pain primarily in my left arm down through my fingers and occasionally in my left leg from my hip down through my foot. It comes and goes and often varies in intensity from nothing to more significant pain.
pt says she started having trouble breathing so went to an Urgent Care where she was told she had allergies and prescribed some allergy medication.  She continued to decline so on 4/28/21 she went ER.   They did Chest X-Rays and other test and was diagnosed w/ blood clots in both lungs.  She was admitted and stayed overnight.  She was released and told to FU w/ Pulmonologist on 5/4/2021 @ 1 PM.
Patient is experiencing symptoms of tennis elbow. Patient has pain radiating from elbow to wrist.
onset of sx 2 days p/vax;sx onset included fever & rash pretty much @ same time, diarrhea, runny nose, dry cough;diarrhea lasted about 2wk;rash came & went 3 times;saw MD 8/9/99;no tx (meds) issued;
AT 8:45 NOTICED RASH ON R ARM FROM SHOULDER DOWN TO ELBOW. FELT WARM AND WAS GIVEN TYLENOL BY PARENT. CHILD WAS CRYING AND DIFFICULT TO CONSOLE. ACTIONS SEEMED UNUSUAL TO PARENT. CHILD SAYS HE HURTS ALL OVER. DOESN'T WANT TO MOVE AROUND IN HIS NORMAL FASHION.  PARENTS TOOK HIM TO PMD TODAY AND TEMP THERE WAS 101.5. MD SAID HE HAD AN ALLERGIC REACTION TO THE PNEUMOVAX 23. CHILD WAS PRESCRIBED PREDNISONE LIQUID STARTING AT 14 ML AND DECREASING BY 2 ML EVERY DAY UNTIL GONE. BENADRYL TWICE A DAY, 1 3/4 TSP.
Patient received her Pneumovax and Fluvirin in separate arms.  She said that around 4 hours after receiving her vaccines, her right arm in which she received her Pneumovax hurt so bad that she could no lift it and she was nauseous and dizzy.  She said that after getting her vaccines she did some yard work and thought that could have been the cause of some of her arm pain. She said her left arm where she got the Fluvirin did not hurt.
Information has been received from a physician concerning a 26 month old female with no pertinent medical history who in approximately 2005 (about two years ago) was vaccinated with varicella virus vaccine live (Oka/Merck) 0.5 mL. There was no concomitant medication. On 11-JUN-2007, the patient experienced multiple spots on thigh and abdomen ("more than 20 spots"). The patient sought unspecified medical attention. No diagnostic laboratory tests were performed. The patient's multiple spots on thigh and abdomen ('more than 20 spots") persisted at the time of the report. No product quality complaint was involved. Additional information has been requested.
Dizziness, dizziness is worse when standing. Oddly enough, the dizziness is worse at night. I feel better each morning, then it gets worse at night. Second night the chills really bad.
Fever of 99.7degrees F for about 36 hours Bad headache Muscle and joint pain
hives, red blotches, small blotches-size of quarter & 1/2 dollar on face & arms;
9 hours after the injection, I developed chills, the inability to regulate my body temperature, shaking, cold, red in the face and a server head ache.  Recovered the next day.
From date of booster my resting heart rate gradually increased each day from 62 bpm to 80 bpm. Weight loss weakness and rapid heart rate. Diagnosed with Thyroiditis based on inflammatory process. I have not been sick in two years and all symptoms began after booster
Acute pain in left arm. No Swelling. No redness. 3 hours after left Pharmacy.
been really tired all day; upset stomach; develop like a red welt in the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (develop like a red welt in the arm), FATIGUE (been really tired all day) and ABDOMINAL DISCOMFORT (upset stomach) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (develop like a red welt in the arm). On an unknown date, the patient experienced FATIGUE (been really tired all day) and ABDOMINAL DISCOMFORT (upset stomach). At the time of the report, VACCINATION SITE ERYTHEMA (develop like a red welt in the arm), FATIGUE (been really tired all day) and ABDOMINAL DISCOMFORT (upset stomach) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drugs were not reported. Treatment information was not provided.
Tiredness; Headache; Chills; Sore throat; don't feel well; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/lot number: Unknown, Expiry Date: Unknown) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that on an unspecified date patient experienced tiredness, headaches, chills, sore throat and don't feel well. Reporter stated he had the first shot of the Pfizer Covid injection, and he was having some of the symptoms, that are listed on the paper they gave him, the after effect and it had been 6 days that he had the shot, and these symptoms were seems to not go away. He was wondering how long he should wait before some these side effects go away. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Around 10 hours after the injection of the shot I began to feel fever and soon after began to hallucinate, hear voices and violently shake. I began to hurt myself by hitting and pulling my hair out. I then ran out into the street in my underwear and called 911 as I was very confused and concerned I would seriously harm myself and others. I was handcuffed by the police but ran away. After being secured and transported to hospital I was administered a sedative drug and released after I was no longer involuntarily shaking.
Arm started hurting  around three hours after the first shot. By 9pm that night the pain had spread to my neck and shoulder on the left side and I was not able to turn my head. My left breast also swelled up. This lasted for three days. The second day, I experienced blood pressure flutters if I stood up to fast or drank anything cold, this last only for a day.
A month after the second dose my menstrual cycle became irregular. I had my cycle in February and no again until April 27,2021 but it was irregular. May was also irregular and very heavy. July is when my period started back being normal.
Information was received on 05-APR-2019 from a lawyer regarding a case in litigation involving a female patient (age and history unknown) who in 2015 the patient was inoculated with ZOSTAVAX for routine health maintenance and prevention of shingles. Shortly after receiving vaccine, the patient broke out in a painful rash and presented to a medical provider and was diagnosed with herpes zoster and post herpetic neuralgia. As a result the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. As a result of ZOSTAVAX the patient's symptoms and diagnoses have resulted in physical limitations not present prior to using the product. As a direct result of ZOSTAVAX the patient sustained severe and permanent personal injuries. The patient suffered serious, progressive, permanent, and incurable injuries as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment, and injury. The patient incurred and will continue to incur medical expenses and other economic harm as a result of ZOSTAVAX. Herpes zoster and post herpetic neuralgia was considered to be disabling. Additional information has been requested.
pt recv vax & became pale & faint was laid out on exam table BP 80/60 breathing fast (hyperventilating) asked to breathe slowly & into paper bag;c/o h/a & tingling in rt arm & hand taken by amb to hosp;
Reporting is for a vaccine administration error where an adult patient was administered the Pfizer-BioTech vaccine  5-11 years   formulation(Orange cap),resulting in a lower than authorized dose for a booster. There is currently no symptoms or adverse event. Patient has been called and correct age appropriate dose of Pfizer-Biotech vaccine has been given as per CDC and vaccine manufacturers
Patient sat for 15 minutes after vaccination and shopped around the store with parent. Started to itch and came back to the pharmacy about 20 minutes after. Small itchy spots were located on both arms and calves area. After some time it was disappearing. But patient took Benadryl when itchy spots were fading. Recommended to see MD as soon as possible. Reported to supervisor and store manager.
Information has been received from the author of a literature. This literature marketed report as received from the authors refers to 14 male patients of unknown age with Human Immunodeficiency Virus HIV infection which was diagnosed in 2 patients before vaccination and in 12 after vaccination. On an unknown date, the patients were vaccinated with a dose of HepB vaccine (recombinant) (manufacturer unknown) (Lot numbers, expiration date, dose and route were not provided). Concomitant medication included combination antiretroviral therapy (cART). On an unspecified date, the patients experienced vaccination failure reported as "vaccine non-responder". The reporter stated that to assess and quantify the effect of HepB vaccine (recombinant) (manufacturer unknown) response on CD4 lymphocytes (CD4) reconstitution after cART initiation, all available CD4 counts for participants from cART initiation to one year post-cART were analyzed. The outcome of vaccination failure was unknown at the time of the report. The reporter considered vaccination failure to be related to HepB vaccine (Recombinant) (manufacturer unknown). This is one of several reports from the same literature. Additional information has been requested.
Hair was coming out/hair was shedding everywhere/hair loss/hair was thin; hair "limp"; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Hair was coming out/hair was shedding everywhere/hair loss/hair was thin) and HAIR TEXTURE ABNORMAL (hair "limp") in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 023C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ALOPECIA (Hair was coming out/hair was shedding everywhere/hair loss/hair was thin) and HAIR TEXTURE ABNORMAL (hair "limp"). At the time of the report, ALOPECIA (Hair was coming out/hair was shedding everywhere/hair loss/hair was thin) and HAIR TEXTURE ABNORMAL (hair "limp") outcome was unknown.            No relevant concomitant product were reported No treatment medication was provided   This case was linked to MOD-2021-414520 (Patient Link).
Axillary lymph node swelling, intense shooting & throbbing pain in underarm area, radiating pain to breast tissue- all above on injection side Large, hard, painful hematoma  at injection site.
Patient 48y/o female was injected with Moderna 0.25ml IM to Left deltoid at Approximately 1030am . Patient then complains of difficulty breathing and throat closure. Patient presents with persistent vomiting. Initial VS B/P 160/67, HR 102, 02 Sat 97% @1035. Epinephrine 0.3ml injected to left thigh, and Benadryl injected to right arm by RN. EMS called. VS at 1040 114/83 HR 98, 02 sat 100%. EMS Arrived at approximately 1100 Received report from RN, assessed  patient and then transported Patient to ER.
screaming for 12 hrs (7PM-7AM); cranky following day; fever 100-101 for 24 hrs;
On July 27th patient's son went to her home and found patient unresponsive face down on the floor.  911 was called.  Per EMS report on their arrival to home, obvious signs of death were noted and patient was pronounced dead at 1214pm
Brown discoloration at the injection site; injection site itchy; injection site raised up; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE DISCOLOURATION (Brown discoloration at the injection site), INJECTION SITE PRURITUS (injection site itchy) and INJECTION SITE SWELLING (injection site raised up) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced INJECTION SITE DISCOLOURATION (Brown discoloration at the injection site), INJECTION SITE PRURITUS (injection site itchy) and INJECTION SITE SWELLING (injection site raised up). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and BETAMETHASONE (CELESTONE [BETAMETHASONE]) at an unspecified dose and frequency. At the time of the report, INJECTION SITE DISCOLOURATION (Brown discoloration at the injection site), INJECTION SITE PRURITUS (injection site itchy) and INJECTION SITE SWELLING (injection site raised up) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitants medications also included Birth control pills
got a shingle vaccine years ago. It didn't work/suspected vaccination failure; got a shingle vaccine years ago. It didn't work; This case was reported by a consumer via interactive digital media and described the occurrence of 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. The patient was treated with acyclovir. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR070612   Additional Information: GSK receipt date: 25-Apr-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got a shingle vaccine years ago from reporting and it did not work. The patient's friend told him/her about acyclovir and that worked. The patient stated that when you felt shingles coming on took an acyclovir 2 times a day for a couple of days and you would not break out with the shingles. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up could not be possible as no contact details were available. The case was linked with case US2022AMR070612, reported by same reporter for different product.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR070612:same patient
This is a spontaneous report from a contactable consumer. This is the second report of the two cases. A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration at single dose on unknown date. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced very sick and not able to go to work with outcome of unknown. Follow-up (27APR2016): Follow-up attempts are completed. No further information is expected.
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: swelling, hard, hot to touch at vaccine site
lt deltoid arm swelling & redness & warmth ? cellulitis;  Erythromycin 400mg tid x 10 days;
Shingles-symptoms 4/9/2021, diagnosed 4/14/2021
Warm; Red or pinkish at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Warm) and INJECTION SITE ERYTHEMA (Red or pinkish at injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 17-Mar-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 INJECTION SITE WARMTH (Warm) and INJECTION SITE ERYTHEMA (Red or pinkish at injection site). At the time of the report, INJECTION SITE WARMTH (Warm) and INJECTION SITE ERYTHEMA (Red or pinkish at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
This spontaneous report as received from a practice manager refers to an unspecified number of patients of unknown age and gender. On 25-FEB-2014 the unspecified number of patient might have been vaccinated with a doses of M-M-R II (hsa) (lot number, dose, frequency, route and site of administration were not reported) that were exposed to temperatures outside of prescribing information that were not supported. No adverse events were reported. Additional information has been requested.
Diagnosed with ductal carcinoma of the right breast in October 2002-T2N0MO, ER negative, PR negative, HER-2/neu positive. Lump noted in October 2002; mammogram and ultrasound confirmed mass. A sentinel node bx was done in November and in December 2002, a right segmental mastectomy with axillary node dissection was performed. She underwent chemotherapy in January 2003 through April 2003. She also had a 5-week course of full breast radiation therapy and pinpoint radiation therapy x 1 1/2 weeks.  8/10/07 Clinical summary from VHC accompanied VAERS report along w/vax record.  Will consider case closed as is.  Patient developed breast cancer in 2002.  Received anthrax vax 1999-2000.  Underwent mastectomy, chemotherapy & radiation therapy in 2003.  Continues f/u every other month w/oncologist. Per 60 day followup: Status unknown, no longer in the military.