chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Started feeling weakness at the back of her neck; red blotches; itchy; disorder sleep; Phone monitoring device and it stated it might be afib and something else (she cannot remember the term); Heart palpitations; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Phone monitoring device and it stated it might be afib and something else (she cannot remember the term)) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lupus erythematosus, Polymyalgia rheumatica, Sjogren's syndrome, Raynaud's syndrome and Hypothyroidism.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In June 2021, the patient experienced ARRHYTHMIA (Phone monitoring device and it stated it might be afib and something else (she cannot remember the term)) (seriousness criterion medically significant), PALPITATIONS (Heart palpitations), MUSCULAR WEAKNESS (Started feeling weakness at the back of her neck), RASH MACULAR (red blotches), PRURITUS (itchy) and SLEEP DISORDER (disorder sleep). At the time of the report, ARRHYTHMIA (Phone monitoring device and it stated it might be afib and something else (she cannot remember the term)), PALPITATIONS (Heart palpitations), MUSCULAR WEAKNESS (Started feeling weakness at the back of her neck), RASH MACULAR (red blotches), PRURITUS (itchy) and SLEEP DISORDER (disorder sleep) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment medication included an unspecified cream for an unknown indication.  A week after the 1st dose (??-Mar-2021), patient reportedly had red blotches on her arms, face, back, thigh and chest areas. She consulted with two doctors and was prescribed with an unspecified cream which did not help. The red blotches are still present - they are itchy and she cannot sleep. She also says that she has to explain to everyone she meets that they are not contagious. She has an appointment with her rheumatologist on the last week of September.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-248016 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
As I was driving, I noticed that my vision was becoming blurred.  I was ready to pull the car over to the side, when it cleared up.  Total time of blurred vision was probably one to two minutes.
Date and time adverse event started: 3-2-21 severe migraine lasted 3-4 days, took 2 aspirin and it went away
This spontaneous report as received from a medical assistant via a company representative refers to a 18 or 19 years old male patient. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown date, the patient was vaccinated with the third dose of GARDASIL 9 injection (dose, route of administration, anatomical location, lot # and expiry date were not specified). On an unknown date, an unspecified time after receiving the third dose of GARDASIL 9, the patient passed out and hit the back of his head. The outcome of the events and the causality assessment were not provided. Additional information has been requested.
I got really high 20 minutes after my shot/ euphoria; Heavy eyelids; Slightly sleepy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07May2021 09:00 (Batch/Lot number: unknown) at the age of 26 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Attention deficit disorder" (unspecified if ongoing), notes: Bipolar disorder, (anxiety, depression, attention issues); "Depression" (unspecified if ongoing), notes: Bipolar disorder, (anxiety, depression, attention issues); "Anxiety" (unspecified if ongoing), notes: Bipolar disorder, (anxiety, depression, attention issues); "Adhesive tape allergy" (unspecified if ongoing), notes: Known allergies: plastic medical tape; "Allergy to surgical sutures" (unspecified if ongoing), notes: Known allergies: black stitches; "Gluten intolerance" (unspecified if ongoing), notes: Known allergies: Gluten; "Tremor of hands" (unspecified if ongoing), notes: Hand tremors; "Insomnia" (unspecified if ongoing); "Bipolar disorder" (unspecified if ongoing), notes: Bipolar disorder, (anxiety, depression, attention issues). Concomitant medication(s) included: LAMOTRIGINE; WELLBUTRIN; PROPRANOLOL; KLONOPIN. Vaccination history included: Bnt162b2 (DOSE 1 SINGLE; Lot number: Unknown, I got really high after my shot. First dose lasting about 30 minute), administration date: Apr2021, when the patient was 26 years old, for COVID-19 immunisation, reaction(s): "got really high". The following information was reported: EUPHORIC MOOD (non-serious) with onset 07May2021 09:00, outcome "recovered" (07May2021 10:00), described as "I got really high 20 minutes after my shot/ euphoria"; ASTHENOPIA (non-serious) with onset 07May2021 09:00, outcome "recovered" (07May2021), described as "Heavy eyelids"; SOMNOLENCE (non-serious) with onset 07May2021 09:00, outcome "recovered" (07May2021), described as "Slightly sleepy". Therapeutic measures were not taken as a result of euphoric mood, asthenopia, somnolence.  Additional information: The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that, the second dose lasted about an hour. On 07May2021 at 09:00, the patient had heavy eyelids, euphoria, slightly sleepy, no disorientation or loss of reactivity or depth perception, no visual or audio changes, no light headedness or physical/body high. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 21-MAY-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally, lot # R034700, expiry date 16-JUN-2020 for prophylaxis. The vaccine was exposed to a temperature of 34.2 Fahrenheit degrees for 4 hours and 54 minutes. Digital data logger was involved. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011674: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000926: US-009507513-1907USA000927: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000928: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000892: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000895: US-009507513-1907USA000929: US-009507513-1907USA000936: US-009507513-1907USA000937: US-009507513-1907USA000938: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000903: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000862: US-009507513-1907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000911: US-009507513-1907USA000912: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000919: US-009507513-1907USA000920: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000882: US-009507513-1907USA000923: US-009507513-1907USA000924: US-009507513-1907USA000925:
On 20 March  2021I had itching, redness, and swelling on left arm.  this was 8 days after receiving the shot.  Contacted doctor office on Monday, 21 March 2021 and reported.  Will start taking fexofenadine (allegra eq) 180 mg TAB once per day
Rash started on thigh within hours of receiving vaccine. Progressed rapidly to torso and face. No resp. sxs. Rash was urticarial.
Rash appeared on neck and chest approximately 8 days after injection.  I have 5 lesions and each lesion has tiny raised blisters bumps that itch and burn with occasion sharp pain in the lymph nodes. Lymph nodes on side of neck under rash are swollen as well.
Patient requested first dose of Pfizer Covid-19 vaccine.  Incentives were being provided.  Later it was discovered that the patient had completed his Modera series.
I have done nothing specific for it, and it continues to hurt now, worse when sleeping and laying on my L side.
Initial information received on 30-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse via phone. This case involves a 62 years old female patient who received a 0.5ml standard immunization of the FLUZONE HIGH DOSE (formulation Suspension for injection in pre-filled syringe) lot UJ052AB, Expiry date 09 June 2019, via unknown route in the left deltoid on 30 Nov 2018. The patient past medical history, medical treatments, vaccinations and family history were not provided. It was a case of actual medication error due to overdose and inappropriate age at vaccine administration. It was reported that 62 years old received a FLUZONE HD. No adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
This initial spontaneous report was received from a nurse referring to multiple unspecified patients of unknown ages and genders. There was no pertinent medical history, concomitant medications or drug allergies/drug reactions described. On unspecified dates, the patients were administered improperly stored doses of ROTATEQ (orally; dose, dose number, lot # and expiration date were not reported). The nurse was not sure what specific vaccines were give, date of administration or to what patients. No adverse effects were reported and a product quality complaint (PQC) was not involved. It was unknown if the patients sought medical attention. This is one of several reports received from the same reporter. Additional information has been requested.
"hives around injection site approx 1 1/2 wk after injection of ProQuad
allergic; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction 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 allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix.     Additional Information: GSK Receipt Date: 12-APR-2022 Reporter's Comment: The patient self-reported this case via digital media.. The patient received dose of Shingrix vaccine and experienced allergic reaction. The patient stated that GlaxoSmithKline should provide consumers with a sample of Shingrix so they could get an allergy test before they get the shot.  How else would anyone knew that they were allergic, GlaxoSmithKline was careless in this regard. The patient asked where could a consumer got an allergy treatment about Shingrix. The patient did not want to get Shingrix never again. Additional supportive information: The follow-up would not possible, as no contact details were available.
Vaccine administered 6/24/11 then developed intense watery stools Q 2-3 hours since then up until presentation today 6/29/11.
Information has been received from a licensed practical nurse concerning a patient who in 1996 was vaccinated with a dose of varicella virus vaccine live. It was reported that the mother of the child reported to the physician that the child developed chicken pox in 1999 following exposure to another unvaccinated sibling who had developed chicken pox after being exposed to the disease in school. The nurse noted that their office had no record of this event and could offer no further information on the matter. No medical attention was sought. No product quality complaint was involved. No further information is expected. It was also reported that the patient's sibling was vaccinated with a dose of varicella virus vaccine live and developed a varicella like rash.
Mild headache with tinnitus (high pitched ringing in ears).  Headache subsided after two days, but ear ringing persists.  I did not have a history of tinnitus prior to the second Moderna COVID19 vaccine dose.
Vesicular rash (L) arm and leg that burned and resembled zoster rash.
Onset of n,v,d w/t103 approx 30 min p/MMR onset of above sx x 4 days p/going to MD; Seen by MD on 13FEB92; pt given ATB? & suppositeries for vomiting sx relieved by 14FEB92;
Hives - over mon of bad - trunk, arms, legs, feet. Nearly fainting.
7 months pregnant, received booster dose. Baby was born at term with healthy weight. Night following the vaccination I woke in the middle of the night with very sore hands.  This continued every night for the duration of my pregnancy. The symptoms are now less but I continue to have sore hands during the night and upon waking and when driving, taking photos and other activities that require steady use of my hands.
Received vaccine on 3/9/21 in my left arm.  On 3/17/21, I developed a raised red rash about 3 to 4 inches in diameter on my left arm in the vicinity of the vaccination site.  It does not appear to be spreading or getting worse.  I have applied Benedryl Gel to the site once and will either continue application or will purchase some Benedryl  pills.
patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion); patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 42-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter was an internal medicine manager.  Concomitant medication of the patient was not reported.  The reporter reported that because their facility had not been able to download the digital data logger, they had been put on hold by the State at the moment and cannot administer the Moderna COVID-19 vaccine to patients until an assessment by the state was made. There had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because the facility was unable to download the digital data logger, this issue was treated as a temperature excursion. The reporter was unable to download the data logger for the months of December 2021, January 2022 and February 2022. The reporter was filling out a temperature excursion assessment with the State.  The reporter mentioned that the patient had been administered dose while the temperature excursion assessment was ongoing. The reporter also reported that, no adverse reactions were reported by the patient.  No treatment information was provided by the reporter.
pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of pregnancy in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     The patient's past medical history included No adverse event (No reported medical history.).   On an unknown date, the patient received first dose of MRNA-1273 (Moderna covid-19 vaccine) (intramuscular).   Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced exposure during pregnancy (pregnancy).   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  At the time of the report, exposure during pregnancy (pregnancy) had resolved.; Reporter's Comments: This is a case of vaccine exposure during pregnancy with no associated AEs for this female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy
I was feverish, felt nauseous, and then passed out twice. My partner called the doctor who advised us to go to the ER. At the ER I passed out again.
30-40 minutes after injection my throat and tongue started to feel swollen and left side of face started to burn and itch followed by feeling of balloon inflating in my head, I had a panic attack and felt like i was separating from my body, extreme spiciness and scared and headache...effects only lasted about an hour, i did not report to hospital or site and recovered within a couple hours. Arm hurt at injection site for 24 hours then became extremely itchy, second night had flu symptoms for about 5 hours, nauseous, burning up, red face and dizziness and chills, subsided quickly. I'm nervous about second shot now.
red itchy rash all over my torso. Approximately around 7pm Sunday night I noticed the rash.
Moderna Covid Vaccine EUA:  Sent to ED from adult care facility (resides at home; PACE program participant with care center attendance multiple days per week.  Received vaccine on 2/3/21 at care center.  On 2/5/21 care center staff sent patient for ED evaluation due to decreased oral intake and activity, general weakness and lethargy, and fever.  Cannot determine exact onset of symptoms but ED presentation was 1 pm on 2/5/21.   Fever on ED presentation recorded as 101.9 F.  Patient  noted to be very sleepy/lethargic; appropriately responding to questions but requiring nearly constant stimulation to stay awake to answer questions.  Workup revealed procalcitonin 0.08, serum creatinine 1.3 (baseline 1.0 to 1.1). Blood cultures and urine culture negative.  CBC not available due to refusal of additional blood work.   Received IV acetaminophen with improvement in fever and mental status.  Discharged home.
burning when he urinates; sharp pain where his navel is; pain in his stomach; This is a spontaneous report from a contactable consumer reporting for himself. An 82-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EL1283), via an unspecified route of administration on 14Jan2021 at SINGLE DOSE for COVID-19 immunisation. Medical history included Parkinson's disease from an unknown date. The doctor told him to make an appointment with his Parkinson's doctor and tell him, maybe that has something do with it. There were no concomitant medications. The patient experienced burning when he urinates for 2 weeks, a sharp pain where his navel is, and pain in his stomach on Jan2021. He was wondering if it could be from the shot or if it is something else. He had an appointment with his doctor on Monday and he told him about it. The doctor gave him an antibiotic, Ciprofloxacin 500 mg that made him dizzy, he does not know if he will continue to take it but it helped the burning, the burning was not as bad. It was in a brown clear pharmacy bottle. The burning when he urinated is going away but the pain in his stomach comes and goes and it is right on his navel, it was described as a real hard pain. Patient would come back 03Feb2021 per vaccination card. Outcome of the event burning when he urinates was recovering while unknown for a sharp pain where his navel is, and pain in his stomach. The events were considered non-serious.
I had a seizure and I am not common to having seizure; This is a spontaneous report from a contactable consumer (patient). A 33-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 33-year-old, dose 2 via an unspecified route of administration, administered in left arm on 21Apr2021 (Lot Number: ER8735) as single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medication included bisoprolol 10 mg. The patient was previously vaccinated with the first dose of BNT162B2 on 31Mar2021 at the age of 33-year-old for COVID-19 immunisation. The patient stated that he had a seizure on 21Apr2021, and he was not common to having seizure. No treatment was received for the event. The outcome of the event was recovering.
Information has been received from a healthcare worker (Certified Medical Assistant) referring to a patient of unknown age. On 06-FEB-2015, the patient was inadvertently administered an expired dose of M-M-R II injection which had expired on 19-JAN-2015, 0.5 ml (unspecified dose series), subcutaneously. No adverse effect reported. No product quality complaint was involved. Additional information has been requested.
Swelling arm around Injection site Immediately after Shot- 10 Days Later Hives that eventually covered her entire Body - Welts and Hives and elevated skin on entire Back and Body Lasted 18 Days - Has Joint Pain Also and Fever of 100.2 deg. Took Benedryl 3x daily and Tylenol 3x daily - I HAVE PHOTO'S IF NEEDED - STILL GETTING FEW HIVES AND PAINFUL JOINTS (8 Weeks After)