chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rheumatoid arthritis flare up; Thyroid nodule; Dry skin; Painful nodule; Localized erythema;   This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4377018-00.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 01Jan2021 as dose 1, single (Batch/Lot number: unknown) and on 01Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 72 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (ongoing) (Batch/Lot number: unknown) at citrate free, subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "recovering", described as "Rheumatoid arthritis flare up"; THYROID MASS (non-serious), outcome "not recovered", described as "Thyroid nodule"; DRY SKIN (non-serious), outcome "not recovered"; NODULE (non-serious), outcome "recovering", described as "Painful nodule"; ERYTHEMA (non-serious), outcome "unknown", described as "Localized erythema". The patient underwent the following laboratory tests and procedures: Test: Five nodules on thyroid; Scan thyroid gland: Unknown Results. The action taken for adalimumab was unknown. Clinical course: Events of non-serious five nodules on thyroid/five nozzles in thyroids, dry skin, could not move or sleep due to painful nodules, rheumatoid arthritis/had flare up/affected left jaw and arm/rheumatoid arthritis flare up not as bad as before and finger and hand red at times with humira (adalimumab). It was unknown if patient was enrolled in a covid-19 vaccine trial.   Causality for Humira (Adalimumab): The reporter's causality for the event(s) of five nodules on thyroid/five nozzles in thyroids, dry skin, rheumatoid arthritis/had flare up/affected left jaw and arm/rheumatoid arthritis flare up not as bad as before and finger and hand red at times was not provided. The reporter's causality for the event(s) of could not move or sleep due to painful nodules with humira(adalimumab) was a reasonable possibility. The reporter considered "rheumatoid arthritis flare up", "thyroid nodule", "dry skin", "painful nodule" and "localized erythema" related to BNT162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the nature of the events Rheumatoid arthritis flare up ,dry skin,  thyroid nodule, erythema, painful nodule a causal relation between the reported events and the administration of the vaccine 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 RAs, Ethics Committees, and Investigators, as appropriate.
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was Acute hypoxemic respiratory failure
Patient was seen at Urgent Care facility after getting vaccinated due to a rash on right calf. Per patient, it was determined that patient had vasculitis that was potentially caused due to vaccine.
tired; trouble sleeping/she was up the entire night/ she slept a little/cannot sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 13:00 (Lot number: EN5318) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "MS", start date: 2001 (unspecified if ongoing), notes: Verbatim: MS; "allergies" (unspecified if ongoing); "compromised immune status" (unspecified if ongoing); "respiratory illness" (unspecified if ongoing); "chromosomal abnormalities" (unspecified if ongoing); "endocrine abnormalities" (unspecified if ongoing); "obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INSOMNIA (non-serious) with onset 04Mar2021, outcome "not recovered", described as "trouble sleeping/she was up the entire night/ she slept a little/cannot sleep"; FATIGUE (non-serious), outcome "unknown", described as "tired". Additional information: Received call from consumer regarding the Pfizer COVID vaccine. She received the first dose 2 weeks ago. That night she was up the entire night. She heard people just slept and she had the opposite. The next night, she slept a little. On the third night, she was up all night again. Now she is tired and cannot sleep. She had the reverse of what she has heard from everyone else. She is curious if this has happened to anyone else. There was no prescriber. It has improved but is still a problem. The injection did not hurt going in. She was unable to confirm if it was given intramuscularly. Time the vaccination was given: Unknown during day around 13:00. She has MS and read about lots of people with MS and no one had this. Everyone was just really tired afterwards. She does not have any information on any others that had those experiences. She was just speaking in generalities and did not have any further details to provide. Anatomical Location of Administration of Pfizer vaccine considered as suspect: Injected in left arm unable to confirm if in the muscle. Not a military facility. Was not able to sleep -21:00. She was up all night long tossing and turning. Felt wide awake and tired at the same time. She never slept the entire night. Really did not sleep again until the following night. The third night again, she did not sleep again.   No follow-up attempts are possible. No further information is expected.
Reportedly, the pt experienced an "immediate reaction-redness, itching, warm to touch and itching around mouth." The pt was seen by a physician.
7 hrs post vax, I exp a total hot flash, then chills and vomiting. It felt like an intense case of the flu but only lasted about 30 min.
Around 1:30 am after shot, started getting restless, hard time sleeping, by morning on 3/7, had fever of 100.4, restless, no energy, lethargic, stomach felt nauseous, good tasted off, felt like I did the first day my covid symptoms started in Jan.
ADMINISTRATION OF VACCINE 1 HOUR AND HALF AFTER  EXPIRY TIME; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 26-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced administration of vaccine 1 hour and half after expiry time. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of vaccine 1 hour and half after expiry time was not reported. This report was non-serious.
This case was reported by a physician and described a pt who did not respond to the Twinrix immunization series. The physician initially reported "2 or 3 pts over the past couple of years"; however, no pt identifiers or dates were provided. On unspecified dates "several years ago", the pt received 3 doses of Twinrix. At an unspecified time after the 3rd injection, the pt "did not obtain an adequate titer level for hepatitis B". The physician reported that he "repeated the hepatitis B series and the pt did seroconvert". On follow-up received from the physician on 1/21/05, the physician stated, "No pts with complications from Twinrix".
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Medium, Systemic: Weakness-Medium
No patients experienced any adverse effects; Improperly stored dose of ROTATEQ; This spontaneous report was received from a physician concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, or drug reactions/allergies.     On 03-APR-2020, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) vial (product storage error), by oral route (lot # S006050, has been verified to be a valid lot number; expiration date 12-DEC-2020) as prophylaxis (dosage schedule and strength were not reported).   The administered dose of the vaccine experienced a multiple temperature excursions below highest temperature above 47 Fahrenheit degrees  to 66.6 Fahrenheit degrees for 2 hours and lowest temperature below 36 Fahrenheit degrees to 33.6 Fahrenheit degrees  for 45 minutes as recorded by a data logger. There was no previous temperature excursion. There was no adverse effect reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA001904: US-009507513-2006USA001905: US-009507513-2006USA001906: US-009507513-2006USA001907: US-009507513-2006USA001908: US-009507513-2006USA001909: US-009507513-006USA001910: US-009507513-2006USA001911: US-009507513-2006USA001912: US-009507513-2006USA001913: US-009507513-2006USA001875: US-009507513-2006USA001876: US-009507513-2006USA001892: US-009507513-2006USA001914: US-009507513-2006USA001915: US-009507513-2006USA001916: US-009507513-2006USA001917: US-009507513-2006USA001893: US-009507513-2006USA001918: US-009507513-2006USA001919: US-009507513-2006USA001894: US-009507513-2006USA001895: US-009507513-2006USA001896: US-009507513-2006USA001897: US-009507513-2006USA001877: US-009507513-2006USA001878: US-009507513-2006USA001879: US-009507513-2006USA001880: US-009507513-2006USA001881: US-009507513-2006USA001882: US-009507513-2006USA001898: US-009507513-2006USA001899: US-009507513-2006USA001883: US-009507513-2006USA001884: US-009507513-2006USA001885: US-009507513-2006USA001886: US-009507513-2006USA001900: US-009507513-2006USA001887: US-009507513-2006USA001888: US-009507513-2006USA001889: US-009507513-2006USA001890: US-009507513-2006USA001903: US-009507513-2006USA001901: US-009507513-2006USA001891: US-009507513-2006USA001902: US-009507513-2006USA001874:
Bad headache, fever, body aches, chills, and soreness in arm at injection site
Discharge Provider: DO Primary Care Provider: MD Admission Date: 9/1/2022 Discharge Date: 9/5/2022  PRESENTING PROBLEM: COPD exacerbation [J44.1] Acute on chronic respiratory failure with hypoxia [J96.21] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a pleasant 73-year-old male admitted with cough shortness of breath and hypoxia does have chronic obstructive pulmonary disease uses 5 L of oxygen at night patient also with history of pneumonias in the past and squamous cell cancer of the lung.  Patient admitted for COVID-19 with hypoxia and exacerbation of his underlying lung disease.  The patient was admitted placed on steroids bronchodilators antibiotics and started on remdesivir.  Patient did receive 5 doses of remdesivir during the hospitalization patient's steroids were weaned off as these were likely exacerbating his delirium.  Clinical condition improved hypoxia resolved lungs improved.  Patient did have some delirium likely on underlying dementia on day of discharge patient is oriented to his name where he is at the year it is in the month.  Patient will need further workup of his memory issues outpatient.  Patient also was supplemented for a potassium of 3.3 and potassium was added to his medications will need a repeat BMP later in the week for re-evaluation this patient discharged in stable condition home with home health care evaluation.
G47.33 OBSTRUCTIVE SLEEP APNEA 4/3/2023 DM 2 W NEUROLOGICAL MANIFESTATION
After the second Covid Shot, my hair started falling out in the top of my head, and my scalp was tender to touch.   It persisted for quite some time.  After the 4th Dose, my scalp again became inflamed.  I eventually went to the dermatologist in July 2022 and was given  Fluocinolone Acetonide Body Oil.  It seemed to have been improving, but I had the last Booster shot on September 17, 2022, and the hair loss increased accompanied by a tender and itchy scalp.
This case was reported by a healthcare professional and described the occurrence of arm cellulitis in a 5-year-old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (Infanrix, GlaxoSmithKline) for prophylaxis. Concurrent vaccinations administered on 25 April 2007 included inactivated poliomyelitis virus vaccine (left deltoid) and live attenuated measles, mumps (strain not specified), rubella vaccine (subcutaneous; right deltoid). Concurrent medications included hydrochloride (Zyrtec). On 25 April 2007 the subject received the fifth dose of Infanrix (0.5 mL, unknown, right deltoid). On 26 April 2007, 1 day after vaccination with Infanrix, the subject experienced cellulitis that was characterized as a local reaction. On 27 April 2007, the subject presented to the physician's office and was diagnosed with cellulitis in his right arm. It was unspecified whether the subject received treatment for cellulitis. This case was assessed as medically serious by GSK. The reporter also identified a product quality complaint, questioning whether there was a problem with the Infanrix lot number that was administered to the subject. At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the event was possibly related to vaccination with Infanrix. Comment: the event "arm cellulitis" is considered to be medically significant by GSK.
Flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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: INFLUENZA (non-serious), outcome "unknown", described as "Flu".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Itching/puffiness at injection site even several days later. Scratches it a little tonight bc it was quite itchy and realized it?s kind of a giant hive (1 1/2?)
pt cried lustily w/the inj;father gave pt bottle to quiet him;w/in 2-3 min father observed that pt was very pale for the next 2hr;color gradually became more pink;questioned vaso-vagal response;
mom stated on 14JUL94 pt face became puffy, having difficulty breathing & listless; mom denies fever-mom called clinic on 15JUL94 & states pt is acting nl;
pt states began exp pain & swelling of rt upper arm down to elbow the evening of the day recv vax;states arm cont to be weak & has difficulty lifting;
4 hours following the yellow fever shot and 3 other shots, I felt dizzy, nauseous, hands and feet cold to the touch, pain in the calves and thighs, and a severe headache. I went to my clinic and they referred me to the Emergency Room. They checked my vitals and stated that they look fine. I was given TYLENOL and Ibuprofen and was discharged. The medicine helped thay night, but the very next day all the symptoms returned.
Started with numbness to the whole body, palpitation, Dyspnea, and increased heart rate. This began 20 minutes after the injection. Lasted about 25 minutes. After this episode subsided, I continued to have persistent Dyspnea, chest pain, palpitations and heart racing. Was unable to speak in full sentences, exercise. Walking short distances caused extreme SOB. These symptoms lasted about a week.
I'm reporting that my Covid symptoms re-occurred 4 days after I completed a 5-day course of Paxlovid.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I'm reporting that my Covid symptoms re-occurred 4 days after I completed a 5-day course of Paxlovid.) in a 71-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 046L21A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Patient medical history reported as no chronic health conditions and patient received unknown historical drug with reaction of allergy.  Previously administered products included for COVID-19 vaccination: PFIZER BIONTECH COVID-19 VACCINE on 31-Mar-2022. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE.   On 16-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In May 2022, the patient experienced COVID-19 (I'm reporting that my Covid symptoms re-occurred 4 days after I completed a 5-day course of Paxlovid.). At the time of the report, COVID-19 (I'm reporting that my Covid symptoms re-occurred 4 days after I completed a 5-day course of Paxlovid.) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication was reported. Covid symptoms re-occurred 4 days after I completed a 5-day course of Paxlovid. Recurrence was reported. No treatment medication was reported.  Company comment: This is a spontaneous case concerning a 71-year-old female patient with no reported medical history, who experienced the unexpected non-serious AESI event of Covid-19. It was reported that Covid symptoms re-occurred 4 days after the patient completed a 5-day course of Paxlovid. The patient received had received a dose of mRNA-1273 (Spikevax) on unknown date. The patient also had taken Pfizer BioNTech covid-19 vaccine on 31-Mar-2022. Outcome of the event was unknown at the time of this report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 71-year-old female patient with no reported medical history, who experienced the unexpected non-serious AESI event of Covid-19. It was reported that Covid symptoms re-occurred 4 days after the patient completed a 5-day course of Paxlovid. The patient received had received a dose of mRNA-1273 (Spikevax) on unknown date. The patient also had taken Pfizer BioNTech covid-19 vaccine on 31-Mar-2022. Outcome of the event was unknown at the time of this report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
urinating more frequently; lump under her chin on the left side/ lump has grown in size over the last hour; dizzy; her heart seems to be beating faster than normal; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), HEART RATE INCREASED (her heart seems to be beating faster than normal), MASS (lump under her chin on the left side/ lump has grown in size over the last hour) and POLLAKIURIA (urinating more frequently) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced DIZZINESS (dizzy) and HEART RATE INCREASED (her heart seems to be beating faster than normal). On 10-Feb-2021, the patient experienced MASS (lump under her chin on the left side/ lump has grown in size over the last hour). On an unknown date, the patient experienced POLLAKIURIA (urinating more frequently). At the time of the report, DIZZINESS (dizzy), HEART RATE INCREASED (her heart seems to be beating faster than normal), MASS (lump under her chin on the left side/ lump has grown in size over the last hour) and POLLAKIURIA (urinating more frequently) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-Feb-2021: No specific follow-up information recorded. On 24-Jun-2021:Significant follow up; Patient reported that AE's not resolved
2 days after the injection, I developed nausea, headache and extreme fatigue.  I slept for most of the following 2 days, and continued to be more fatigued than normal for about a week.  I then had flu-like symptoms  (lower GI, nausea, headache, fatigue) that lasted about 3 days and caused me to miss work.
Patient experienced cellulitis and is being treated by her primary care physician. She expressed concern the immunizing pharmacist did not change gloves between unlocking /opening the door to the consultation room, and injecting her.
Day of administration, could not lift arm, continued to ache randomly. Pain shoots down arm and up to neck. Pain comes and goes, still experiencing symptoms.
This spontaneous prospective pregnancy report was received from a medical assistant and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 09-OCT-2018, the patient was 9.5 weeks pregnant with last menstrual period on approximately 03-AUG-2018. On that day, she was inadvertently vaccinated with GARDASIL 9 intramuscularly, lot # N035955, expiration date on 09-OCT-2020 (dose, frequency and site of administration were not reported) for prophylaxis (Inadvertent exposure to vaccine, Vaccine exposure during pregnancy, Maternal exposure during pregnancy, first trimester). No adverse effect was reported. At the time of the report the pregnancy outcome was pending with estimated delivery date (EDD) on 10-MAY-2019. The outcome of Vaccine exposure during pregnancy and Maternal exposure during pregnancy was unknown.
pt recv vax 2OCT95 & 24hr p/vax devel h/a, fever, myalgia;
This spontaneous report as received from a certified medical assistant (C.M.A.) (also reported as a nurse) refers to an unspecified number of unspecified patients of unknown age and gender. On an unknown dates, the patients were vaccinated with doses of VARIVAX (Merck) (dose, frequency and therapy route were not specified by the reporter, lot# and expiration date were not reported) that were improperly stored. No adverse experienced were reported. Product quality complain (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Fever for 50 hrs with antipyretics,  headache for 4 days, stiff neck for 4 days,  sore arm for 4 days, leg cramps 24 hrs after injection on and off for 36 hrs , pain in joints started 12 hrs after injection and lasted for 48 hrs, difficulty sleeping for 3 nights post injection.
Info has been received from a physician concerning a female who was vaccinated with a dose of MMRII. In August 2005, the pt developed persistent rash. It was reported that "the rash has been present for more than 5 days". Unspecified medical attention was sought. At the time of the report, the pt had not yet recovered. No product quality complaint was involved. Additional info has been requested.
8/5/08 - Enlarged lymph nodes left neck - Submandibular and left axilla. 8/6/08 - Rash on chest, face and arms; fatigue