chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 10May2022 as dose 4 (booster), single (Lot number: fk9394), 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes mellitus" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Jun2022) Positive, notes: Positive Covid test results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Information: The patient received vaccine. Adverse event included Covid symptoms recur on 15Jun and positive covid test results. Other medication in 2 weeks were not reported. Anti-viral product included Paxlovid for Covid-19 treatment started from 03Jun2022 till 08Jun2022. The patient had no known allergies.   No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a medical assistant refers to an 11-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported. On 02-AUG-2018, the patient was inadvertently vaccinated with an adult dose of VAQTA (lot # N032753, expiration date 23-MAR-2019) 1 ml, intramuscularly as a second dose in immunization. The medical assistant stated that vaccinator (unspecified) inadvertently selected wrong strength of vaccine. No adverse effects reported.
Sinus and head congestion for 5 days, followed by shoulder pain, tinnitus, and profound hearing loss in left ear. Diagnosed as sudden sensorineural hearing loss. Treatment included steroids and hyperbaric chamber treatment.
Hives, airway swelling, and profound hypotension (systolic BP 70s to 80s, diastolic BP palpable only).
I had swelling of my shoulder and left arm. I also had pain down my neck and fingers in my left arm. This went away in about 4 days. The only remaining symptom was pain in my index finger on my left hand.
Adult patient received Hiberix; Patient completed series when younger; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 29-year-old male patient who received Hib (Hiberix) (batch number 97AP3, expiry date 09-NOV-2023) for prophylaxis.   On 06-APR-2023, the patient received Hiberix. On 06-APR-2023, an unknown time after receiving Hiberix, the patient experienced adult use of a child product (Verbatim: Adult patient received Hiberix) and extra dose administered (Verbatim: Patient completed series when younger). The outcome of the adult use of a child product and extra dose administered were unknown.   Additional Information: GSK Receipt Date: 21-APR-2023 The occupational medicine clinician called to inquire that how to proceed to make sure patient was protected?  The reporter reported they inadvertently administered Hiberix to an adult patient.  The vaccine was administered in their facility.  The reporter confirmed that the patient completed series when younger.  The reporter did not consent to follow-up. The adult patient received Hiberix, which led to adult use of a child product and extra dose administered.
Patient received 7th Anthrax booster on 13 Aug 2014 at around 10am. Patient complained that at 10pm that night he had hot and cold flashes, chills, felt feverish, difficulty breathing and moving. Patient said symptoms began to dissipate at around 5am the next day. Patient did not go to the E.R. ergo no treatment was made. Patient is overdue for next booster but is concerned due to prior reaction. Provider unsure to exempt the patient due to no documentation of treatment or reaction until now.
high fever for at least 4 days, shaking, chills, vomiting, fussiness, sleepliness, shallow labored breathing, racing heart beat, lack of hunger, weight loss
Breakthrough COVID infection in fully vaccinated patient. Positive date 09/12/2021.
Pulmonary embolism; This is a spontaneous report from a contactable nurse.   A 69-year-old male patient received the second dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. The patient was otherwise healthy. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. On an unspecified date, a few weeks after the second dose, the patient experienced pulmonary embolism (PE) and he was on anticoagulants. The reporter asked about reports of polychondritis, as a different patient reported this "many months after their dose". The outcome of event was unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Got Shingrix, 2 months later got COVID; This case was reported by a consumer via call center representative and described the occurrence of covid-19 in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2021, the patient received the 1st dose of Shingrix. In December 2021, 2 months after receiving Shingrix, the patient experienced covid-19. On an unknown date, the outcome of the covid-19 was recovered/resolved.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.  Additional details were provided as follows: The case was self reported by the patient. The patient received Shingrix vaccine mid of October then 2 months later contracted COVID.  They referred to health care professional.  The reporter did not consent to follow up.
Bell's palsy; shingles (3x's); This case was reported by a consumer via market research programs and described the occurrence of bell's palsy in a patient who received Flu unspecified (Flu vaccine unspecified) for prophylaxis.   On an unknown date, the patient received Flu vaccine unspecified. On an unknown date, unknown after receiving Flu vaccine unspecified, the patient experienced bell's palsy (serious criteria GSK medically significant) and shingles. Flu vaccine unspecified was discontinued. On an unknown date, the outcome of the bell's palsy and shingles were recovered/resolved.   It was unknown if the reporter considered the bell's palsy and shingles to be related to Flu vaccine unspecified.  Additional Information: GSK Receipt Date: 19-May-2022. Reporter's Comments: This case was reported by the patient. The patient used to get seasonal flu shots until the patient started having reactions shingles (3x's), Bell's palsy. So, the patient stopped getting vaccinations and the patient stopped having problems. Additional Supportive Information: The follow-up would not possible as no contact details were available.  This was 1 of the 18 cases reported by same reporter.
ABOUT 4 HOURS AFTER GETTING THE VACCINE, HER ARM STARTED HURTING REALLY BAD AND SHE SAID SHE COULDN'T MOVE IT. HER HUSBAND HELPED HER MOVE IT AROUND AND SHE SAID IT STILL HURT, BUT HAD LOOSENED UP A LITTLE. SHE WENT AND LAID DOWN. AFTER 1 HOUR, SHE STATED THAT SHE "COULDN'T FEEL HER ARM AT ALL." SHE WENT TO THE ER AND WAS TOLD THAT IT "WAS A PROBLEM WITH THE TENDON, AND LIKELY DUE TO THE PNEUMOVAX VACCINE." I'M NOT SURE WHAT THEY TREATED HER WITH IN THE ER, BUT SHE DID REGAIN FEELING IN HER ARM, BUT STILL STATES THAT HER ARM IS "VERY SORE."
Approximately 3 weeks after first COVID shot (Pfizer), noticed shortness of breath symptoms consistently that have lasted every single day for the past 7-8 weeks. Have been to Emergency Room, followed by Cardiologist, Pulmonologist, etc and my heart and lungs are fine... physical therapist I've been to multiple times says the intercostal muscles in my ribs keep getting inflammed for an unknown reason and that is making it to where my lungs can't fully expand.   Practically speaking, it means that for the last 2 months I've felt awful and felt like I can't breathe. I've never had any issues with this before and I was a healthy 30 year old. Even my general practitioner thinks that it was the vaccine at this point since nothing else changed.
Information has been received from a registered nurse concerning a 76 year old male insurance agent with no pertinent medical history who on 02-FEB-2010 was vaccinated intramuscularly with a dose of PNEUMOVAX 23 (664864/1365Y) into his left deltoid at 10:30 AM. On 03-FEB-2010 at the early morning the patient experienced swelling of left arm, tender and redness. It was reported that the patient did not require emergency room or doctor visit. On 06-FEB-2010 the patient recovered from these events. Additional information has been requested.
Weakness, ataxia, dysphasia, dysphagia, coarse tremor.  Dx:  Guillain-Barre, Miller-Fisher variant.
MILD ARM SORENESS THAT GOT SPIKED; This spontaneous report received from a patient concerned a 61 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203AZIA, expiry: 23/JUN/2021) dose was not reported, administered on 08-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced mild arm soreness that got spiked. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild arm soreness that got spiked on MAY-2021. This report was non-serious. This case, from the same reporter is linked to 20210518415.
No Adverse reaction to shot. Contracted positive Home test for COVID with symptoms Fever for 2 days high of 102.1 no loss of taste no loss of smell. Body aches during fever.
Patient has a rash that started with her thighs (which has now resolved) and is now on her neck, chest, and face. Patient being given topical steroid cream for her neck and chest and told to stop homeopathic treatments to face and use cool towels to reduce irritation and itching to face (patient has been trying a lot of different topical homeopathic treatments  to face, i.e. tea tree oil, flax see oil, etc. that may be worsening irritation to face. )
I got the shingles vaccine, and I had slight reaction to it with a fever. After about 5 days of feeling terrible, I called my doctor and said if the symptoms progressed, I should test for COVID-19. On day 9, I decided to test and came back positive for COVID-19. I lost my taste and sense of smell, higher fever, and terrible fatigue. The fever altered through the days, from low-grade to high-grade. I developed a terrible headache that lasted for 10 days. Currently, I still haven't regained my taste and smell back.
First dose, experienced a dead arm in the injection arm, which was the right arm; Couldn't lift arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Aug2021 11:00 (Lot number: EW0182) at the age of 45 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Neurofibromatosis, type 1 (von Recklinghausen's disease)" (ongoing), notes: Diagnosed at 36 years old. Is a tumor condition inside of her body. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Aug2021, outcome "recovered" (Aug2021), described as "First dose, experienced a dead arm in the injection arm, which was the right arm"; MOBILITY DECREASED (non-serious) with onset Aug2021, outcome "recovered" (Aug2021), described as "Couldn't lift arm".  Additional information: After the first dose, the patient experienced a dead arm in the injection arm, which was the right arm. Couldn't lift arm because it hurt. Felt like was punched in the arm. Was continuous. Lasted only for a few hours and passed. Recovered completely. No medicine changes. No investigations were done.   No follow-up attempts are possible. No further information is expected.
This spontaneous case was reported by a patient and describes the occurrence of COUGH (phlegm cough) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The patient's past medical history included Bronchitis (yearly bronchitis when working in an office) and Cough (past before when patient gets sick (non Covid)). Concomitant products included PIROXICAM (ZICAM [PIROXICAM]) and CALCIUM ASCORBATE (VITAMIN C [CALCIUM ASCORBATE]) for an unknown indication. In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Jun-2022, the patient experienced COUGH (phlegm cough). At the time of the report, COUGH (phlegm cough) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: (Negative) Negative. No treatment drugs were reported. Patient got the original vaccine apr2021 and the booster in Dec2021. Patient wants to know when the booster dose becomes effective, if it's a few days after or a few weeks. Patient going for a PCR test on 12Jul2022. Patient states she got tired with the 1st dose and was concerned with traveling if patient will be stuck with side effects if patient does get the booster before she leaves. It was reported that consent not obtained. This case was linked to MOD-2022-606275 (Patient Link). Reporter did not allow further contact
Little side effect; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Little side effect) 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 Historical condition reported).    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Little side effect). At the time of the report, ADVERSE REACTION (Little side effect) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Information has been received from a nurse practitioner concerning a patient who in May 2007, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Concomitant vaccination on that same day included an unknown vaccine. In May 2007, the patient's arm swelled up. Pediatric office follow-up scheduled. Unknown present status for patient reported. No product quality complaint reported. No further information is available.
Mom states right upper arm swollen from shoulder to elbow red and warm.  She states arm started swelling same day as shot.  No fever per mom.  He will see his doctor today for evaluation.
Severe shoulder pain; fluid drawn, infection confirmed, arthroscopic surgery performed, shoulder "lavaged".
Mild rash c/w post vaccination break through case of VERICELLA 10 or less red papalar vesicular lesions on left foot, right thigh, abd, right hand and ahterun neck.
sore left arm; extreme fatigue starting 6 hours after her first dose and lasting for two days; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (sore left arm) and FATIGUE (extreme fatigue starting 6 hours after her first dose and lasting for two days) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore left arm) and FATIGUE (extreme fatigue starting 6 hours after her first dose and lasting for two days). In January 2021, FATIGUE (extreme fatigue starting 6 hours after her first dose and lasting for two days) had resolved. At the time of the report, VACCINATION SITE PAIN (sore left arm) outcome was unknown.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Patient reported that her left arm hurt so much that she had to ice her arm.   This case was linked to MOD-2022-583835, MOD-2022-583836 (Patient Link).
BREATHING RELATED SLEEP DISORDER 5/2/2023 OBSERVATION AND EVALUATION FOR SUSPECTED CONDITION
Vaccine was stored in refrigerator on 11-Jan-2022 and Vaccine administered on 20-Apr-2022; Vaccine was stored in refrigerator on 11-Jan-2022 and Vaccine administered on 20-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in refrigerator on 11-Jan-2022 and Vaccine administered on 20-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 11-Jan-2022 and Vaccine administered on 20-Apr-2022) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (Lot EN6203) on 01-Apr-2021, Pfizer (Lot EN6203) on 22-Apr-2021 and Pfizer (Lot FE3592) on 06-Oct-2021. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer.    On 20-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in refrigerator on 11-Jan-2022 and Vaccine administered on 20-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 11-Jan-2022 and Vaccine administered on 20-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in refrigerator on 11-Jan-2022 and Vaccine administered on 20-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 11-Jan-2022 and Vaccine administered on 20-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  The vial was initially stored in the refrigerator on 11-Jan-2022. Patient received second booster on 20-Apr-2022. The vial did not undergo any temperature excursions. The patient did not reported adverse reaction.  Treatment information was not provided by the reporter.
In September of 2022 I started experiencing dyspnea, this would happen either at rest or during exercise. I thought that it may just be caused by stress or allergies. In February the dyspnea got worse, I experienced chest pain, upset stomach, I felt pain in jaw, back pain, I had diarrhea. I went to the emergency room thinking I may be having a heart attack. They did a chest x-ray, blood work, EKG. I was discharged as they did not see that I was having a heart attack and told me I was fine. I made an appointment with my primary care physician. He ordered that I wear a Holter monitor, pulmonary stress test, echocardiogram, cardiac stress test. I failed the PFT and cardiac stress test, I was referred to a pulmonologist that I am awaiting to get into an appointment.
On 5/06, I had a very bad headache and felt nauseous. I have had similar headaches in the past so I did not connect it with Covid. On 5/07 I noticed some nasal sinus congestion with sniffling and sneezing that felt like I was getting a cold. The sinus symptoms persisted for the next week after that. I also feel like I may have had a fever a few times but did not take my temperature. Since I was going on 2 weeks with these cold like symptoms and dry cough, I decided to get tested for Covid on 5/16 and the positive results came in on 5/18. I then spoke with the Covid hotline and a nurse on 5/18 to get some general information about what I needed to do. I spoke with my doctor on 5/20. My doctor prescribed an inhaler which I have not used due to issues I have with my eye pressure. I have been taking Mucinex and over the counter cough syrup and my symptoms have been gradually improving.
PATIENT UPON ENTERING THE ROOM SAID HE WAS NERVOUS ABOUT NEEDLES. I PROCEEDED TO TALK TO HIM ABOUT IT AND GAVE HIM THE VACCINE, HE SEEMED FINE. A COUPLE MINUTES AFTER HE WENT TO WAITING AREA TO WAIT 15 MINUTES HIS MOTHER/FRIEND CAME AND SAID I SHOULD COME OUT THERE. HIS EYES WERE KINDA ROLLING AND I RUBBED HIS ARM AND HE CAME TO COMPLETELY. HE NEVER COMPLETELY PASSED OUT, BUT HE BECAME VERY SWEATY AND WAS VERY PALE. HE SAID HE HADN'T DRANK OR EATEN MUCH THAT DAY. WE GAVE HIM A BOTTLE OF WATER AND HE SEEMED TO BE FINE. HE WAITED ABOUT 20 MINUTES AND THEN LEFT
Significant pain in left arm shortly after injection.  Pain continued and on January 13th developed a rash and swelling at the injection site.   On January 17th, rash on left arm increased in size
(L) arm because very swollen and painful to move. Symptoms lasted approx 3 days, but were improved each day.
Shingrix cause swelling in axillary lymph nodes; This case was reported by a consumer via interactive digital media and described the occurrence of axillary lymph nodes enlarged in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced axillary lymph nodes enlarged. On an unknown date, the outcome of the axillary lymph nodes enlarged was unknown.   It was unknown if the reporter considered the axillary lymph nodes enlarged to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not provided. The patient received Shingrix and had swelling in axillary lymph nodes. The patient asked if this could be the side effect of Shingrix.
Myalgia, NauseaVomiting, FATIGUE, CHILLS, DRY MOUTH, FEELING TIRED Narrative:
Severe headache, nausea, diarrhea, tachycardia, shortness of breath, fluid in lower lobes of lungs, elevated O BNP, high temperature >103. Blood pressure increased
Severe Tinnitus that has not dissipated as of March 31, 2021